Periodontal Diseases, Chronic Periodontitis, Periodontal Pocket, Tooth Mobility, Gingival Diseases, Smoking, Cigarette
Conditions
Keywords
Oral Health, Smoking, Cigarette, Reduced risk product, Tobacco heating system, THS, Modified risk tobacco product, Clinical attachment level
Brief summary
The purpose of this study was to demonstrate in patients with generalized chronic periodontitis that switching from cigarette smoking to using IQOS improves the response to periodontal therapy and the overall oral health status compared to continuing cigarette smoking. Note: IQOS is the Tobacco Heating System (THS) with Marlboro Heatsticks, marketed in Japan under the brand name IQOS
Detailed description
This was a randomized, controlled, open-label, 2-arm, parallel group ambulatory study with the randomization stratified by daily cigarette consumption over the month (30 days) prior to Visit 1 (10-19 cigarettes/day vs. \> 19 cigarettes/day) and disease severity recorded at Visit 1 (\< 5 mm Pocket Depth \[PD\] vs. ≥ 5 mm PD) based on the most severely diseased tooth, in smokers with generalized chronic periodontitis who are randomized to either switch from cigarette smoking to IQOS use or continuing cigarette smoking.
Interventions
Sponsors
Philip Morris Products S.A.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Masking description
The Dentist (Investigator) or Dental Hygienist performing the periodontal assessments will be blinded to the arm allocation.
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: 1. Patient is aged ≥ 30 years old. 2. Patient has smoked on average at least 10 commercially available cigarettes per day for at least 5 years 3. Patient has generalized chronic periodontitis (i.e., more than 30% of diseased teeth with a PD ≥ 4 mm). Main
Exclusion criteria
1. Patient has self-reported history of diagnosed systemic diseases (e.g., stroke or acute cardiovascular event within the last 5 years, diabetes, active cancer). 2. Patient received root planing therapy within the 6 months prior to Visit 1. 3. Patient received surgical periodontal therapy within 3 years prior to Visit 4. Patient was treated within the 3 months prior to Visit 1 with systemic antibiotics or was treated with topical antibiotics applied in the mouth. 5. Continuous systemic use of steroidal or non-steroidal anti-inflammatory drugs for more than 20 days during the past 30-day period (except for low dose aspirin, i.e., ≤300 mg). 6. Female patients who are pregnant, breast-feeding, or planning a pregnancy within the course of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Periodontal Pocket Depth (PD) Change From Baseline at 6 Months | At 6 months | Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean Periodontal PD change from baseline will be measured in all sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) | At 3 months and 6 months | Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Mean CAL change from baseline will be measured in sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking. |
| Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics | From baseline to 3 months and 6 months | Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean Periodontal PD change from baseline will be measured in all sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking. |
| Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics | From baseline to 3 months and 6 months | Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Mean CAL change from baseline will be measured in sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking. |
| Full-mouth Periodontal PD Change Over Time. | From baseline to 3 months and 6 months | Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Change in mean full-mouth PD will be measured, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking. |
| Full-mouth Clinical Attachment Level (CAL) Over Time. | From baseline to 3 months and 6 months | Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Change in mean full-mouth CAL will be measured, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking. |
| Peridontal PD Reduction. | From baseline to 3 months and 6 months | Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean PD change will be measured in sites with initial PD \< 4 mm, and with initial PD of 4 mm to \<5 mm, 5 mm to \< 6 mm, 6 mm to \< 7 mm and ≥ 7 mm. |
| Clinical Attachment Level Improvement | From baseline to 3 months and 6 months | Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Mean CAL change will be measured in sites with initial PD \< 4 mm, and with initial PD of 4 mm to \<5 mm, 5 mm to \< 6 mm, 6 mm to \< 7 mm and ≥ 7 mm. |
| Number of Periodontally Diseased Sites. | From baseline to 3 months and 6 months | Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Any change will be recorded in the number of periodontally diseased sites with Pocket Depth (PD) \< 4 mm, with PD 4 mm to \< 5mm, with PD 5 mm to \< 6 mm , with PD 6 mm to \< 7 mm and with PD ≥ 7 mm. PD is the distance from the gingival margin to which a probe penetrates into the pocket. |
| Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) | At 3 months | Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean Periodontal PD change from baseline will be measured in all sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking. |
| Tooth Mobility | From baseline to 3 months and 6 months | Tooth mobility will be graded according to Miller's mobility index (MMI), which is the most widely accepted method for routine clinical examinations of tooth mobility. The tooth is held between the metallic handles of two instruments and moved in the buccolingual or buccopalatal direction, and the moved distance is visually estimated by the person conducting the examination. Grade 0: Physiologic movement within 0.2 mm; Grade 1: Slight mobility, tooth can be moved 0.2 - 1 mm labiolingually; Grade 2: Moderate mobility, tooth can be moved 1 - 2 mm labiolingually or mesiodistally; Grade 3: Severe mobility, tooth can be moved more than 2 mm labiolingually or mesiodistally, or ability to depress the tooth in a vertical direction. |
| Presence of Plaque on Tooth Surfaces in Full Mouth | From baseline to 3 months and 6 months | Plaque will be measured using the plaque control record (PCR) percentage. |
| Inflammatory Status in Periodontal Pockets | From baseline to 3 months and 6 months | Gum inflammation was measured using percentage of teeth bleeding on probing (BOP). BOP in full mouth was measured to assess inflammatory status in the pocket and was assessed as YES or NO of bleeding at 6 sites per tooth. Gently probing (approximately 20 g pressure), the bleeding site within 30 seconds was assessed as YES. |
| Concentrations of Urinary Nicotine Equivalents (NEQ) | From baseline to 3 months and 6 months | This biomarker of exposure to a tobacco smoke constituent will be measured in patients who switch to IQOS use and patients who continue cigarette smoking. Concentrations measured in urine and expressed as concentration adjusted for creatinine (mg/g creat). |
| Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | From baseline to 3 months and 6 months | This biomarker of exposure to a tobacco smoke constituent will be measured in patients who switch to IQOS use and patients who continue cigarette smoking. Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). |
| Concentrations of 2-cyanoethylmercapturic Acid (CEMA) | From baseline to 3 months and 6 months | This biomarker of exposure to a tobacco smoke constituent will be measured in patients who switch to IQOS use and patients who continue cigarette smoking. Concentrations measured in urine and expressed as concentration adjusted for creatinine (ng/mg creat). |
| Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking. | From baseline to 6 months | Self-reported use of tobacco or nicotine containing products will be measured over the study in patients switching to IQOS use and patients who continue cigarette smoking. |
| Gingival Inflammation | From baseline to 3 months and 6 months | Gingival inflammation will be measured by calculating the gingival index (GI) score for each target tooth. The gingival index (GI) scores each site on a 0 to 3 scale, with 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding. |
Countries
Japan
Participant flow
Pre-assignment details
179 subjects were enrolled in the study. 172 subjects were randomized to the IQOS arm (n=87) or to the cigarette arm (n=85). The analysis was performed according to subjects' exposure (Product Use Category, i.e., IQOS; Cigarette; Dual use; or Other) over the study period as detailed in the Arm/Group (Reporting Groups) table.
Participants by arm
| Arm | Count |
|---|---|
| IQOS IQOS Product Use Category | 70 |
| Cigarette Cigarette Product Use Category | 84 |
| Dual User Dual User Product Use Category | 17 |
| Other Other Product Use Category | 1 |
| Total | 172 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Cigarette | IQOS | Dual User | Other | Total |
|---|---|---|---|---|---|
| Age, Continuous | 46.5 years | 48.1 years | 54.4 years | 54.0 years | 48.0 years |
| Nationality Japanese | 84 Participants | 70 Participants | 17 Participants | 1 Participants | 172 Participants |
| Nationality Non-Japanese | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 84 Participants | 70 Participants | 17 Participants | 1 Participants | 172 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Japan | 84 participants | 70 participants | 17 participants | 1 participants | 172 participants |
| Sex: Female, Male Female | 17 Participants | 13 Participants | 3 Participants | 0 Participants | 33 Participants |
| Sex: Female, Male Male | 67 Participants | 57 Participants | 14 Participants | 1 Participants | 139 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 91 | 0 / 17 | 0 / 1 |
| other Total, other adverse events | 25 / 70 | 29 / 91 | 13 / 17 | 1 / 1 |
| serious Total, serious adverse events | 0 / 70 | 2 / 91 | 0 / 17 | 0 / 1 |
Outcome results
Primary
Periodontal Pocket Depth (PD) Change From Baseline at 6 Months
Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean Periodontal PD change from baseline will be measured in all sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
Time frame: At 6 months
Population: The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements). The Other reporting group, which included one subject, was not included in this analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| IQOS | Periodontal Pocket Depth (PD) Change From Baseline at 6 Months | -1.046 millimeters |
| Cigarette | Periodontal Pocket Depth (PD) Change From Baseline at 6 Months | -1.114 millimeters |
| Dual User | Periodontal Pocket Depth (PD) Change From Baseline at 6 Months | -1.177 millimeters |
Comparison: Month 6: Difference between Cigarette and IQOSp-value: 0.29795% CI: [-0.06, 0.196]Mixed Models Analysis
Comparison: Month 6: Difference between Cigarette and Dual Usep-value: 0.5595% CI: [-0.273, 0.146]Mixed Models Analysis
Secondary
Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm)
Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Mean CAL change from baseline will be measured in sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
Time frame: At 3 months and 6 months
Population: The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements). The Other reporting group, which included one subject, was not included in this analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| IQOS | Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) | Month 3: Change from Baseline | -0.820 millimeters |
| IQOS | Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) | Month 6: Change from Baseline | -0.903 millimeters |
| Cigarette | Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) | Month 3: Change from Baseline | -0.889 millimeters |
| Cigarette | Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) | Month 6: Change from Baseline | -0.995 millimeters |
| Dual User | Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) | Month 3: Change from Baseline | -0.865 millimeters |
| Dual User | Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) | Month 6: Change from Baseline | -1.100 millimeters |
Comparison: Month 6: Difference between Cigarette and Dual Usep-value: 0.41795% CI: [-0.359, 0.15]Mixed Models Analysis
Comparison: Month 3: Difference between Cigarette and IQOSp-value: 0.37695% CI: [-0.085, 0.224]Mixed Models Analysis
Comparison: Month 3: Difference between Cigarette and DualUsep-value: 0.84895% CI: [-0.229, 0.279]Mixed Models Analysis
Comparison: Month 6: Difference between Cigarette and IQOSp-value: 0.24695% CI: [-0.064, 0.247]Mixed Models Analysis
Secondary
Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics
Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Mean CAL change from baseline will be measured in sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
Time frame: From baseline to 3 months and 6 months
Population: The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| IQOS | Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics | Baseline | 4.65 millimeters |
| IQOS | Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics | Month 6 | 3.74 millimeters |
| IQOS | Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics | Month 3 | 3.82 millimeters |
| Cigarette | Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics | Baseline | 4.64 millimeters |
| Cigarette | Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics | Month 6 | 3.69 millimeters |
| Cigarette | Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics | Month 3 | 3.79 millimeters |
| Dual User | Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics | Month 3 | 3.87 millimeters |
| Dual User | Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics | Baseline | 4.60 millimeters |
| Dual User | Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics | Month 6 | 3.64 millimeters |
| Other | Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics | Baseline | 4.13 millimeters |
| Other | Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics | Month 6 | 3.21 millimeters |
| Other | Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics | Month 3 | 3.20 millimeters |
Secondary
Clinical Attachment Level Improvement
Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Mean CAL change will be measured in sites with initial PD \< 4 mm, and with initial PD of 4 mm to \<5 mm, 5 mm to \< 6 mm, 6 mm to \< 7 mm and ≥ 7 mm.
Time frame: From baseline to 3 months and 6 months
Population: The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| IQOS | Clinical Attachment Level Improvement | <4mm (Baseline) | 3.0 millimeters |
| IQOS | Clinical Attachment Level Improvement | 6mm-7mm (Month 6: Change from Baseline) | -1.3 millimeters |
| IQOS | Clinical Attachment Level Improvement | 5mm-6mm (Month 6: Change from Baseline) | -1.0 millimeters |
| IQOS | Clinical Attachment Level Improvement | <4mm (Month 6: Change from Baseline) | -0.2 millimeters |
| IQOS | Clinical Attachment Level Improvement | 6mm-7mm (Baseline) | 6.2 millimeters |
| IQOS | Clinical Attachment Level Improvement | 6mm-7mm (Month 3: Change from Baseline) | -1.0 millimeters |
| IQOS | Clinical Attachment Level Improvement | 4mm-5mm (Baseline) | 4.2 millimeters |
| IQOS | Clinical Attachment Level Improvement | <4mm (Month 3: Change from Baseline) | -0.2 millimeters |
| IQOS | Clinical Attachment Level Improvement | ≥7mm (Month 3: Change from Baseline) | -1.3 millimeters |
| IQOS | Clinical Attachment Level Improvement | 4mm-5mm (Month 3: Change from Baseline) | -0.7 millimeters |
| IQOS | Clinical Attachment Level Improvement | 4mm-5mm (Month 6: Change from Baseline) | -0.8 millimeters |
| IQOS | Clinical Attachment Level Improvement | ≥7mm (Baseline) | 7.5 millimeters |
| IQOS | Clinical Attachment Level Improvement | 5mm-6mm (Baseline) | 5.2 millimeters |
| IQOS | Clinical Attachment Level Improvement | ≥7mm (Month 6: Change from Baseline) | -1.6 millimeters |
| IQOS | Clinical Attachment Level Improvement | 5mm-6mm (Month 3: Change from Baseline) | -0.9 millimeters |
| Cigarette | Clinical Attachment Level Improvement | 5mm-6mm (Month 3: Change from Baseline) | -1.0 millimeters |
| Cigarette | Clinical Attachment Level Improvement | 6mm-7mm (Month 6: Change from Baseline) | -1.3 millimeters |
| Cigarette | Clinical Attachment Level Improvement | 4mm-5mm (Month 3: Change from Baseline) | -0.7 millimeters |
| Cigarette | Clinical Attachment Level Improvement | 5mm-6mm (Month 6: Change from Baseline) | -1.1 millimeters |
| Cigarette | Clinical Attachment Level Improvement | <4mm (Month 3: Change from Baseline) | -0.2 millimeters |
| Cigarette | Clinical Attachment Level Improvement | 6mm-7mm (Month 3: Change from Baseline) | -1.0 millimeters |
| Cigarette | Clinical Attachment Level Improvement | ≥7mm (Baseline) | 7.9 millimeters |
| Cigarette | Clinical Attachment Level Improvement | 6mm-7mm (Baseline) | 6.3 millimeters |
| Cigarette | Clinical Attachment Level Improvement | <4mm (Month 6: Change from Baseline) | -0.2 millimeters |
| Cigarette | Clinical Attachment Level Improvement | 5mm-6mm (Baseline) | 5.2 millimeters |
| Cigarette | Clinical Attachment Level Improvement | ≥7mm (Month 6: Change from Baseline) | -1.9 millimeters |
| Cigarette | Clinical Attachment Level Improvement | ≥7mm (Month 3: Change from Baseline) | -1.7 millimeters |
| Cigarette | Clinical Attachment Level Improvement | 4mm-5mm (Month 6: Change from Baseline) | -0.8 millimeters |
| Cigarette | Clinical Attachment Level Improvement | 4mm-5mm (Baseline) | 4.2 millimeters |
| Cigarette | Clinical Attachment Level Improvement | <4mm (Baseline) | 3.0 millimeters |
| Dual User | Clinical Attachment Level Improvement | 5mm-6mm (Month 3: Change from Baseline) | -0.8 millimeters |
| Dual User | Clinical Attachment Level Improvement | <4mm (Baseline) | 2.9 millimeters |
| Dual User | Clinical Attachment Level Improvement | <4mm (Month 3: Change from Baseline) | 0.0 millimeters |
| Dual User | Clinical Attachment Level Improvement | <4mm (Month 6: Change from Baseline) | -0.2 millimeters |
| Dual User | Clinical Attachment Level Improvement | 4mm-5mm (Baseline) | 4.3 millimeters |
| Dual User | Clinical Attachment Level Improvement | 4mm-5mm (Month 3: Change from Baseline) | -0.6 millimeters |
| Dual User | Clinical Attachment Level Improvement | 4mm-5mm (Month 6: Change from Baseline) | -0.8 millimeters |
| Dual User | Clinical Attachment Level Improvement | 5mm-6mm (Baseline) | 5.2 millimeters |
| Dual User | Clinical Attachment Level Improvement | 5mm-6mm (Month 6: Change from Baseline) | -1.2 millimeters |
| Dual User | Clinical Attachment Level Improvement | 6mm-7mm (Baseline) | 6.3 millimeters |
| Dual User | Clinical Attachment Level Improvement | 6mm-7mm (Month 3: Change from Baseline) | -1.2 millimeters |
| Dual User | Clinical Attachment Level Improvement | 6mm-7mm (Month 6: Change from Baseline) | -1.7 millimeters |
| Dual User | Clinical Attachment Level Improvement | ≥7mm (Baseline) | 8.8 millimeters |
| Dual User | Clinical Attachment Level Improvement | ≥7mm (Month 3: Change from Baseline) | -1.6 millimeters |
| Dual User | Clinical Attachment Level Improvement | ≥7mm (Month 6: Change from Baseline) | -2.0 millimeters |
| Other | Clinical Attachment Level Improvement | 5mm-6mm (Baseline) | 5.0 millimeters |
| Other | Clinical Attachment Level Improvement | <4mm (Month 3: Change from Baseline) | -0.1 millimeters |
| Other | Clinical Attachment Level Improvement | 6mm-7mm (Month 6: Change from Baseline) | NA millimeters |
| Other | Clinical Attachment Level Improvement | 4mm-5mm (Month 6: Change from Baseline) | -0.9 millimeters |
| Other | Clinical Attachment Level Improvement | 4mm-5mm (Month 3: Change from Baseline) | -0.9 millimeters |
| Other | Clinical Attachment Level Improvement | <4mm (Baseline) | 2.6 millimeters |
| Other | Clinical Attachment Level Improvement | ≥7mm (Baseline) | NA millimeters |
| Other | Clinical Attachment Level Improvement | 4mm-5mm (Baseline) | 4.1 millimeters |
| Other | Clinical Attachment Level Improvement | <4mm (Month 6: Change from Baseline) | -0.1 millimeters |
| Other | Clinical Attachment Level Improvement | ≥7mm (Month 6: Change from Baseline) | NA millimeters |
| Other | Clinical Attachment Level Improvement | 6mm-7mm (Baseline) | NA millimeters |
| Other | Clinical Attachment Level Improvement | 5mm-6mm (Month 6: Change from Baseline) | -1.8 millimeters |
| Other | Clinical Attachment Level Improvement | ≥7mm (Month 3: Change from Baseline) | NA millimeters |
| Other | Clinical Attachment Level Improvement | 6mm-7mm (Month 3: Change from Baseline) | NA millimeters |
| Other | Clinical Attachment Level Improvement | 5mm-6mm (Month 3: Change from Baseline) | -1.2 millimeters |
Secondary
Concentrations of 2-cyanoethylmercapturic Acid (CEMA)
This biomarker of exposure to a tobacco smoke constituent will be measured in patients who switch to IQOS use and patients who continue cigarette smoking. Concentrations measured in urine and expressed as concentration adjusted for creatinine (ng/mg creat).
Time frame: From baseline to 3 months and 6 months
Population: The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| IQOS | Concentrations of 2-cyanoethylmercapturic Acid (CEMA) | Month 6 | 7.56 ng/mg creat |
| IQOS | Concentrations of 2-cyanoethylmercapturic Acid (CEMA) | Month 3 | 9.94 ng/mg creat |
| IQOS | Concentrations of 2-cyanoethylmercapturic Acid (CEMA) | Baseline | 67.29 ng/mg creat |
| Cigarette | Concentrations of 2-cyanoethylmercapturic Acid (CEMA) | Month 6 | 76.65 ng/mg creat |
| Cigarette | Concentrations of 2-cyanoethylmercapturic Acid (CEMA) | Month 3 | 80.30 ng/mg creat |
| Cigarette | Concentrations of 2-cyanoethylmercapturic Acid (CEMA) | Baseline | 90.44 ng/mg creat |
| Dual User | Concentrations of 2-cyanoethylmercapturic Acid (CEMA) | Baseline | 92.10 ng/mg creat |
| Dual User | Concentrations of 2-cyanoethylmercapturic Acid (CEMA) | Month 6 | 69.02 ng/mg creat |
| Dual User | Concentrations of 2-cyanoethylmercapturic Acid (CEMA) | Month 3 | 50.36 ng/mg creat |
| Other | Concentrations of 2-cyanoethylmercapturic Acid (CEMA) | Month 6 | 1.97 ng/mg creat |
| Other | Concentrations of 2-cyanoethylmercapturic Acid (CEMA) | Month 3 | 5.19 ng/mg creat |
| Other | Concentrations of 2-cyanoethylmercapturic Acid (CEMA) | Baseline | 140.95 ng/mg creat |
Secondary
Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)
This biomarker of exposure to a tobacco smoke constituent will be measured in patients who switch to IQOS use and patients who continue cigarette smoking. Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat).
Time frame: From baseline to 3 months and 6 months
Population: The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| IQOS | Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | Baseline | 83.30 pg/mg creat |
| IQOS | Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | Month 6 | 22.55 pg/mg creat |
| IQOS | Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | Mionth 3 | 25.77 pg/mg creat |
| Cigarette | Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | Baseline | 112.52 pg/mg creat |
| Cigarette | Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | Month 6 | 96.70 pg/mg creat |
| Cigarette | Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | Mionth 3 | 100.67 pg/mg creat |
| Dual User | Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | Mionth 3 | 68.62 pg/mg creat |
| Dual User | Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | Baseline | 93.01 pg/mg creat |
| Dual User | Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | Month 6 | 77.17 pg/mg creat |
| Other | Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | Baseline | 159.05 pg/mg creat |
| Other | Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | Month 6 | 48.74 pg/mg creat |
| Other | Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | Mionth 3 | 124.39 pg/mg creat |
Secondary
Concentrations of Urinary Nicotine Equivalents (NEQ)
This biomarker of exposure to a tobacco smoke constituent will be measured in patients who switch to IQOS use and patients who continue cigarette smoking. Concentrations measured in urine and expressed as concentration adjusted for creatinine (mg/g creat).
Time frame: From baseline to 3 months and 6 months
Population: The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| IQOS | Concentrations of Urinary Nicotine Equivalents (NEQ) | Baseline | 6.777 mg/g creat |
| IQOS | Concentrations of Urinary Nicotine Equivalents (NEQ) | Month 6 | 6.471 mg/g creat |
| IQOS | Concentrations of Urinary Nicotine Equivalents (NEQ) | Month 3 | 6.766 mg/g creat |
| Cigarette | Concentrations of Urinary Nicotine Equivalents (NEQ) | Baseline | 7.649 mg/g creat |
| Cigarette | Concentrations of Urinary Nicotine Equivalents (NEQ) | Month 6 | 6.563 mg/g creat |
| Cigarette | Concentrations of Urinary Nicotine Equivalents (NEQ) | Month 3 | 6.699 mg/g creat |
| Dual User | Concentrations of Urinary Nicotine Equivalents (NEQ) | Month 3 | 5.911 mg/g creat |
| Dual User | Concentrations of Urinary Nicotine Equivalents (NEQ) | Baseline | 6.452 mg/g creat |
| Dual User | Concentrations of Urinary Nicotine Equivalents (NEQ) | Month 6 | 5.467 mg/g creat |
| Other | Concentrations of Urinary Nicotine Equivalents (NEQ) | Baseline | 8.527 mg/g creat |
| Other | Concentrations of Urinary Nicotine Equivalents (NEQ) | Month 6 | 5.213 mg/g creat |
| Other | Concentrations of Urinary Nicotine Equivalents (NEQ) | Month 3 | 7.681 mg/g creat |
Secondary
Full-mouth Clinical Attachment Level (CAL) Over Time.
Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Change in mean full-mouth CAL will be measured, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
Time frame: From baseline to 3 months and 6 months
Population: The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| IQOS | Full-mouth Clinical Attachment Level (CAL) Over Time. | Baseline | 3.48 millimeters |
| IQOS | Full-mouth Clinical Attachment Level (CAL) Over Time. | Month 6 | 3.10 millimeters |
| IQOS | Full-mouth Clinical Attachment Level (CAL) Over Time. | Month 3 | 3.10 millimeters |
| Cigarette | Full-mouth Clinical Attachment Level (CAL) Over Time. | Baseline | 3.52 millimeters |
| Cigarette | Full-mouth Clinical Attachment Level (CAL) Over Time. | Month 6 | 3.09 millimeters |
| Cigarette | Full-mouth Clinical Attachment Level (CAL) Over Time. | Month 3 | 3.13 millimeters |
| Dual User | Full-mouth Clinical Attachment Level (CAL) Over Time. | Month 3 | 3.15 millimeters |
| Dual User | Full-mouth Clinical Attachment Level (CAL) Over Time. | Baseline | 3.34 millimeters |
| Dual User | Full-mouth Clinical Attachment Level (CAL) Over Time. | Month 6 | 2.97 millimeters |
| Other | Full-mouth Clinical Attachment Level (CAL) Over Time. | Baseline | 2.99 millimeters |
| Other | Full-mouth Clinical Attachment Level (CAL) Over Time. | Month 6 | 2.70 millimeters |
| Other | Full-mouth Clinical Attachment Level (CAL) Over Time. | Month 3 | 2.70 millimeters |
Secondary
Full-mouth Periodontal PD Change Over Time.
Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Change in mean full-mouth PD will be measured, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
Time frame: From baseline to 3 months and 6 months
Population: The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| IQOS | Full-mouth Periodontal PD Change Over Time. | Baseline | 3.15 millimeters |
| IQOS | Full-mouth Periodontal PD Change Over Time. | Month 6 | 2.70 millimeters |
| IQOS | Full-mouth Periodontal PD Change Over Time. | Month 3 | 2.70 millimeters |
| Cigarette | Full-mouth Periodontal PD Change Over Time. | Baseline | 3.20 millimeters |
| Cigarette | Full-mouth Periodontal PD Change Over Time. | Month 6 | 2.72 millimeters |
| Cigarette | Full-mouth Periodontal PD Change Over Time. | Month 3 | 2.78 millimeters |
| Dual User | Full-mouth Periodontal PD Change Over Time. | Month 3 | 2.69 millimeters |
| Dual User | Full-mouth Periodontal PD Change Over Time. | Baseline | 2.99 millimeters |
| Dual User | Full-mouth Periodontal PD Change Over Time. | Month 6 | 2.62 millimeters |
| Other | Full-mouth Periodontal PD Change Over Time. | Baseline | 2.92 millimeters |
| Other | Full-mouth Periodontal PD Change Over Time. | Month 6 | 2.55 millimeters |
| Other | Full-mouth Periodontal PD Change Over Time. | Month 3 | 2.57 millimeters |
Secondary
Gingival Inflammation
Gingival inflammation will be measured by calculating the gingival index (GI) score for each target tooth. The gingival index (GI) scores each site on a 0 to 3 scale, with 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding.
Time frame: From baseline to 3 months and 6 months
Population: The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| IQOS | Gingival Inflammation | Month 3: Change from Baseline | -0.40 Gingival Index (GI) |
| IQOS | Gingival Inflammation | Month 6 | 1.03 Gingival Index (GI) |
| IQOS | Gingival Inflammation | Month 6: Change from Baseline | -0.43 Gingival Index (GI) |
| IQOS | Gingival Inflammation | Month 3 | 1.06 Gingival Index (GI) |
| IQOS | Gingival Inflammation | Baseline | 1.46 Gingival Index (GI) |
| Cigarette | Gingival Inflammation | Month 3 | 1.08 Gingival Index (GI) |
| Cigarette | Gingival Inflammation | Month 3: Change from Baseline | -0.40 Gingival Index (GI) |
| Cigarette | Gingival Inflammation | Baseline | 1.48 Gingival Index (GI) |
| Cigarette | Gingival Inflammation | Month 6 | 1.04 Gingival Index (GI) |
| Cigarette | Gingival Inflammation | Month 6: Change from Baseline | -0.44 Gingival Index (GI) |
| Dual User | Gingival Inflammation | Month 6: Change from Baseline | -0.41 Gingival Index (GI) |
| Dual User | Gingival Inflammation | Baseline | 1.46 Gingival Index (GI) |
| Dual User | Gingival Inflammation | Month 3 | 1.22 Gingival Index (GI) |
| Dual User | Gingival Inflammation | Month 3: Change from Baseline | -0.24 Gingival Index (GI) |
| Dual User | Gingival Inflammation | Month 6 | 1.05 Gingival Index (GI) |
| Other | Gingival Inflammation | Month 3 | 0.5 Gingival Index (GI) |
| Other | Gingival Inflammation | Month 6 | 1.38 Gingival Index (GI) |
| Other | Gingival Inflammation | Baseline | 1.38 Gingival Index (GI) |
| Other | Gingival Inflammation | Month 6: Change from Baseline | 0.00 Gingival Index (GI) |
| Other | Gingival Inflammation | Month 3: Change from Baseline | -0.88 Gingival Index (GI) |
Secondary
Inflammatory Status in Periodontal Pockets
Gum inflammation was measured using percentage of teeth bleeding on probing (BOP). BOP in full mouth was measured to assess inflammatory status in the pocket and was assessed as YES or NO of bleeding at 6 sites per tooth. Gently probing (approximately 20 g pressure), the bleeding site within 30 seconds was assessed as YES.
Time frame: From baseline to 3 months and 6 months
Population: The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| IQOS | Inflammatory Status in Periodontal Pockets | Month 6 | 26.90 BOP % |
| IQOS | Inflammatory Status in Periodontal Pockets | Month 3 | 26.68 BOP % |
| IQOS | Inflammatory Status in Periodontal Pockets | Month 6: Change from Baseline | -14.85 BOP % |
| IQOS | Inflammatory Status in Periodontal Pockets | Month 3: Change from Baseline | -14.57 BOP % |
| IQOS | Inflammatory Status in Periodontal Pockets | Baseline | 41.25 BOP % |
| Cigarette | Inflammatory Status in Periodontal Pockets | Month 3: Change from Baseline | -18.72 BOP % |
| Cigarette | Inflammatory Status in Periodontal Pockets | Month 6 | 23.80 BOP % |
| Cigarette | Inflammatory Status in Periodontal Pockets | Month 6: Change from Baseline | -18.71 BOP % |
| Cigarette | Inflammatory Status in Periodontal Pockets | Month 3 | 24.21 BOP % |
| Cigarette | Inflammatory Status in Periodontal Pockets | Baseline | 42.93 BOP % |
| Dual User | Inflammatory Status in Periodontal Pockets | Month 3: Change from Baseline | -11.78 BOP % |
| Dual User | Inflammatory Status in Periodontal Pockets | Baseline | 30.80 BOP % |
| Dual User | Inflammatory Status in Periodontal Pockets | Month 3 | 19.03 BOP % |
| Dual User | Inflammatory Status in Periodontal Pockets | Month 6 | 19.80 BOP % |
| Dual User | Inflammatory Status in Periodontal Pockets | Month 6: Change from Baseline | -11.00 BOP % |
| Other | Inflammatory Status in Periodontal Pockets | Month 6 | 38.10 BOP % |
| Other | Inflammatory Status in Periodontal Pockets | Month 3 | 53.57 BOP % |
| Other | Inflammatory Status in Periodontal Pockets | Baseline | 48.81 BOP % |
| Other | Inflammatory Status in Periodontal Pockets | Month 3: Change from Baseline | 4.76 BOP % |
| Other | Inflammatory Status in Periodontal Pockets | Month 6: Change from Baseline | -10.71 BOP % |
Secondary
Number of Periodontally Diseased Sites.
Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Any change will be recorded in the number of periodontally diseased sites with Pocket Depth (PD) \< 4 mm, with PD 4 mm to \< 5mm, with PD 5 mm to \< 6 mm , with PD 6 mm to \< 7 mm and with PD ≥ 7 mm. PD is the distance from the gingival margin to which a probe penetrates into the pocket.
Time frame: From baseline to 3 months and 6 months
Population: The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IQOS | Number of Periodontally Diseased Sites. | 6mm - 7mm: Baseline | 291 Number of sites |
| IQOS | Number of Periodontally Diseased Sites. | 5mm - 6mm: Month 6 | 333 Number of sites |
| IQOS | Number of Periodontally Diseased Sites. | 4mm - 5mm: Month 6 | 934 Number of sites |
| IQOS | Number of Periodontally Diseased Sites. | Missing/Not done: Month 6 | 7 Number of sites |
| IQOS | Number of Periodontally Diseased Sites. | 5mm - 6mm: Month 3 | 366 Number of sites |
| IQOS | Number of Periodontally Diseased Sites. | 5mm - 6mm: Baseline | 724 Number of sites |
| IQOS | Number of Periodontally Diseased Sites. | Missing/Not done: Baseline | 26 Number of sites |
| IQOS | Number of Periodontally Diseased Sites. | ≥7mm: Month 6 | 126 Number of sites |
| IQOS | Number of Periodontally Diseased Sites. | <4mm: Month 6 | 9241 Number of sites |
| IQOS | Number of Periodontally Diseased Sites. | <4mm: Baseline | 7688 Number of sites |
| IQOS | Number of Periodontally Diseased Sites. | ≥7mm: Month 3 | 124 Number of sites |
| IQOS | Number of Periodontally Diseased Sites. | ≥7mm: Baseline | 220 Number of sites |
| IQOS | Number of Periodontally Diseased Sites. | 4mm - 5mm: Baseline | 2067 Number of sites |
| IQOS | Number of Periodontally Diseased Sites. | Missing/Not done: Month 3 | 6 Number of sites |
| IQOS | Number of Periodontally Diseased Sites. | 6mm - 7mm: Month 6 | 189 Number of sites |
| IQOS | Number of Periodontally Diseased Sites. | 6mm - 7mm: Month 3 | 151 Number of sites |
| IQOS | Number of Periodontally Diseased Sites. | 4mm - 5mm: Month 3 | 1037 Number of sites |
| IQOS | Number of Periodontally Diseased Sites. | <4mm: Month 3 | 9332 Number of sites |
| Cigarette | Number of Periodontally Diseased Sites. | <4mm: Month 6 | 11199 Number of sites |
| Cigarette | Number of Periodontally Diseased Sites. | <4mm: Baseline | 9194 Number of sites |
| Cigarette | Number of Periodontally Diseased Sites. | <4mm: Month 3 | 11146 Number of sites |
| Cigarette | Number of Periodontally Diseased Sites. | 4mm - 5mm: Baseline | 2571 Number of sites |
| Cigarette | Number of Periodontally Diseased Sites. | 4mm - 5mm: Month 3 | 1393 Number of sites |
| Cigarette | Number of Periodontally Diseased Sites. | 4mm - 5mm: Month 6 | 1241 Number of sites |
| Cigarette | Number of Periodontally Diseased Sites. | 5mm - 6mm: Baseline | 1042 Number of sites |
| Cigarette | Number of Periodontally Diseased Sites. | 5mm - 6mm: Month 3 | 483 Number of sites |
| Cigarette | Number of Periodontally Diseased Sites. | 5mm - 6mm: Month 6 | 426 Number of sites |
| Cigarette | Number of Periodontally Diseased Sites. | 6mm - 7mm: Baseline | 333 Number of sites |
| Cigarette | Number of Periodontally Diseased Sites. | 6mm - 7mm: Month 3 | 238 Number of sites |
| Cigarette | Number of Periodontally Diseased Sites. | 6mm - 7mm: Month 6 | 219 Number of sites |
| Cigarette | Number of Periodontally Diseased Sites. | ≥7mm: Baseline | 222 Number of sites |
| Cigarette | Number of Periodontally Diseased Sites. | ≥7mm: Month 3 | 113 Number of sites |
| Cigarette | Number of Periodontally Diseased Sites. | ≥7mm: Month 6 | 120 Number of sites |
| Cigarette | Number of Periodontally Diseased Sites. | Missing/Not done: Baseline | 12 Number of sites |
| Cigarette | Number of Periodontally Diseased Sites. | Missing/Not done: Month 3 | 1 Number of sites |
| Cigarette | Number of Periodontally Diseased Sites. | Missing/Not done: Month 6 | 1 Number of sites |
| Dual User | Number of Periodontally Diseased Sites. | 4mm - 5mm: Month 3 | 261 Number of sites |
| Dual User | Number of Periodontally Diseased Sites. | 6mm - 7mm: Baseline | 55 Number of sites |
| Dual User | Number of Periodontally Diseased Sites. | 6mm - 7mm: Month 3 | 31 Number of sites |
| Dual User | Number of Periodontally Diseased Sites. | 4mm - 5mm: Baseline | 469 Number of sites |
| Dual User | Number of Periodontally Diseased Sites. | Missing/Not done: Month 6 | 0 Number of sites |
| Dual User | Number of Periodontally Diseased Sites. | 6mm - 7mm: Month 6 | 23 Number of sites |
| Dual User | Number of Periodontally Diseased Sites. | Missing/Not done: Month 3 | 1 Number of sites |
| Dual User | Number of Periodontally Diseased Sites. | ≥7mm: Baseline | 15 Number of sites |
| Dual User | Number of Periodontally Diseased Sites. | <4mm: Month 6 | 2227 Number of sites |
| Dual User | Number of Periodontally Diseased Sites. | ≥7mm: Month 3 | 10 Number of sites |
| Dual User | Number of Periodontally Diseased Sites. | <4mm: Baseline | 1911 Number of sites |
| Dual User | Number of Periodontally Diseased Sites. | ≥7mm: Month 6 | 7 Number of sites |
| Dual User | Number of Periodontally Diseased Sites. | <4mm: Month 3 | 2181 Number of sites |
| Dual User | Number of Periodontally Diseased Sites. | 5mm - 6mm: Baseline | 136 Number of sites |
| Dual User | Number of Periodontally Diseased Sites. | 4mm - 5mm: Month 6 | 259 Number of sites |
| Dual User | Number of Periodontally Diseased Sites. | 5mm - 6mm: Month 3 | 102 Number of sites |
| Dual User | Number of Periodontally Diseased Sites. | Missing/Not done: Baseline | 0 Number of sites |
| Dual User | Number of Periodontally Diseased Sites. | 5mm - 6mm: Month 6 | 76 Number of sites |
| Other | Number of Periodontally Diseased Sites. | 5mm - 6mm: Baseline | 4 Number of sites |
| Other | Number of Periodontally Diseased Sites. | Missing/Not done: Baseline | 0 Number of sites |
| Other | Number of Periodontally Diseased Sites. | ≥7mm: Month 3 | 0 Number of sites |
| Other | Number of Periodontally Diseased Sites. | 6mm - 7mm: Baseline | 0 Number of sites |
| Other | Number of Periodontally Diseased Sites. | 4mm - 5mm: Baseline | 37 Number of sites |
| Other | Number of Periodontally Diseased Sites. | <4mm: Baseline | 127 Number of sites |
| Other | Number of Periodontally Diseased Sites. | <4mm: Month 3 | 154 Number of sites |
| Other | Number of Periodontally Diseased Sites. | 6mm - 7mm: Month 3 | 0 Number of sites |
| Other | Number of Periodontally Diseased Sites. | 4mm - 5mm: Month 3 | 14 Number of sites |
| Other | Number of Periodontally Diseased Sites. | Missing/Not done: Month 6 | 0 Number of sites |
| Other | Number of Periodontally Diseased Sites. | ≥7mm: Month 6 | 0 Number of sites |
| Other | Number of Periodontally Diseased Sites. | 6mm - 7mm: Month 6 | 0 Number of sites |
| Other | Number of Periodontally Diseased Sites. | <4mm: Month 6 | 159 Number of sites |
| Other | Number of Periodontally Diseased Sites. | 4mm - 5mm: Month 6 | 8 Number of sites |
| Other | Number of Periodontally Diseased Sites. | 5mm - 6mm: Month 6 | 1 Number of sites |
| Other | Number of Periodontally Diseased Sites. | ≥7mm: Baseline | 0 Number of sites |
| Other | Number of Periodontally Diseased Sites. | 5mm - 6mm: Month 3 | 0 Number of sites |
| Other | Number of Periodontally Diseased Sites. | Missing/Not done: Month 3 | 0 Number of sites |
Secondary
Peridontal PD Reduction.
Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean PD change will be measured in sites with initial PD \< 4 mm, and with initial PD of 4 mm to \<5 mm, 5 mm to \< 6 mm, 6 mm to \< 7 mm and ≥ 7 mm.
Time frame: From baseline to 3 months and 6 months
Population: The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| IQOS | Peridontal PD Reduction. | <4mm (Baseline) | 2.5 millimeters |
| IQOS | Peridontal PD Reduction. | 6mm-7mm (Month 6: Change from Baseline) | -1.5 millimeters |
| IQOS | Peridontal PD Reduction. | 5mm-6mm (Month 6: Change from Baseline) | -1.2 millimeters |
| IQOS | Peridontal PD Reduction. | <4mm (Month 6: Change from Baseline) | -0.2 millimeters |
| IQOS | Peridontal PD Reduction. | 6mm-7mm (Baseline) | 6.0 millimeters |
| IQOS | Peridontal PD Reduction. | 6mm-7mm (Month 3: Change from Baseline) | -1.3 millimeters |
| IQOS | Peridontal PD Reduction. | 4mm-5mm (Baseline) | 4.0 millimeters |
| IQOS | Peridontal PD Reduction. | <4mm (Month 3: Change from Baseline) | -0.2 millimeters |
| IQOS | Peridontal PD Reduction. | ≥7mm (Month 3: Change from Baseline) | -2.1 millimeters |
| IQOS | Peridontal PD Reduction. | 4mm-5mm (Month 3: Change from Baseline) | -0.8 millimeters |
| IQOS | Peridontal PD Reduction. | 4mm-5mm (Month 6: Change from Baseline) | -0.9 millimeters |
| IQOS | Peridontal PD Reduction. | ≥7mm (Baseline) | 7.6 millimeters |
| IQOS | Peridontal PD Reduction. | 5mm-6mm (Baseline) | 5.0 millimeters |
| IQOS | Peridontal PD Reduction. | ≥7mm (Month 6: Change from Baseline) | -2.3 millimeters |
| IQOS | Peridontal PD Reduction. | 5mm-6mm (Month 3: Change from Baseline) | -1.2 millimeters |
| Cigarette | Peridontal PD Reduction. | 5mm-6mm (Month 3: Change from Baseline) | -1.1 millimeters |
| Cigarette | Peridontal PD Reduction. | 6mm-7mm (Month 6: Change from Baseline) | -1.4 millimeters |
| Cigarette | Peridontal PD Reduction. | 4mm-5mm (Month 3: Change from Baseline) | -0.8 millimeters |
| Cigarette | Peridontal PD Reduction. | 5mm-6mm (Month 6: Change from Baseline) | -1.2 millimeters |
| Cigarette | Peridontal PD Reduction. | <4mm (Month 3: Change from Baseline) | -0.2 millimeters |
| Cigarette | Peridontal PD Reduction. | 6mm-7mm (Month 3: Change from Baseline) | -1.2 millimeters |
| Cigarette | Peridontal PD Reduction. | ≥7mm (Baseline) | 7.5 millimeters |
| Cigarette | Peridontal PD Reduction. | 6mm-7mm (Baseline) | 6.0 millimeters |
| Cigarette | Peridontal PD Reduction. | <4mm (Month 6: Change from Baseline) | -0.2 millimeters |
| Cigarette | Peridontal PD Reduction. | 5mm-6mm (Baseline) | 5.0 millimeters |
| Cigarette | Peridontal PD Reduction. | ≥7mm (Month 6: Change from Baseline) | -1.7 millimeters |
| Cigarette | Peridontal PD Reduction. | ≥7mm (Month 3: Change from Baseline) | -1.6 millimeters |
| Cigarette | Peridontal PD Reduction. | 4mm-5mm (Month 6: Change from Baseline) | -0.9 millimeters |
| Cigarette | Peridontal PD Reduction. | 4mm-5mm (Baseline) | 4.0 millimeters |
| Cigarette | Peridontal PD Reduction. | <4mm (Baseline) | 2.6 millimeters |
| Dual User | Peridontal PD Reduction. | 5mm-6mm (Month 3: Change from Baseline) | -1.0 millimeters |
| Dual User | Peridontal PD Reduction. | <4mm (Baseline) | 2.5 millimeters |
| Dual User | Peridontal PD Reduction. | <4mm (Month 3: Change from Baseline) | -0.1 millimeters |
| Dual User | Peridontal PD Reduction. | <4mm (Month 6: Change from Baseline) | -0.1 millimeters |
| Dual User | Peridontal PD Reduction. | 4mm-5mm (Baseline) | 4.0 millimeters |
| Dual User | Peridontal PD Reduction. | 4mm-5mm (Month 3: Change from Baseline) | -0.8 millimeters |
| Dual User | Peridontal PD Reduction. | 4mm-5mm (Month 6: Change from Baseline) | -0.8 millimeters |
| Dual User | Peridontal PD Reduction. | 5mm-6mm (Baseline) | 5.0 millimeters |
| Dual User | Peridontal PD Reduction. | 5mm-6mm (Month 6: Change from Baseline) | -1.2 millimeters |
| Dual User | Peridontal PD Reduction. | 6mm-7mm (Baseline) | 6.0 millimeters |
| Dual User | Peridontal PD Reduction. | 6mm-7mm (Month 3: Change from Baseline) | -1.4 millimeters |
| Dual User | Peridontal PD Reduction. | 6mm-7mm (Month 6: Change from Baseline) | -1.8 millimeters |
| Dual User | Peridontal PD Reduction. | ≥7mm (Baseline) | 8.4 millimeters |
| Dual User | Peridontal PD Reduction. | ≥7mm (Month 3: Change from Baseline) | -2.5 millimeters |
| Dual User | Peridontal PD Reduction. | ≥7mm (Month 6: Change from Baseline) | -2.3 millimeters |
| Other | Peridontal PD Reduction. | 5mm-6mm (Baseline) | 5.0 millimeters |
| Other | Peridontal PD Reduction. | <4mm (Month 3: Change from Baseline) | -0.1 millimeters |
| Other | Peridontal PD Reduction. | 6mm-7mm (Month 6: Change from Baseline) | NA millimeters |
| Other | Peridontal PD Reduction. | 4mm-5mm (Month 6: Change from Baseline) | -0.9 millimeters |
| Other | Peridontal PD Reduction. | 4mm-5mm (Month 3: Change from Baseline) | -1.0 millimeters |
| Other | Peridontal PD Reduction. | <4mm (Baseline) | 2.6 millimeters |
| Other | Peridontal PD Reduction. | ≥7mm (Baseline) | NA millimeters |
| Other | Peridontal PD Reduction. | 4mm-5mm (Baseline) | 4.0 millimeters |
| Other | Peridontal PD Reduction. | <4mm (Month 6: Change from Baseline) | -0.1 millimeters |
| Other | Peridontal PD Reduction. | ≥7mm (Month 6: Change from Baseline) | NA millimeters |
| Other | Peridontal PD Reduction. | 6mm-7mm (Baseline) | NA millimeters |
| Other | Peridontal PD Reduction. | 5mm-6mm (Month 6: Change from Baseline) | -2.0 millimeters |
| Other | Peridontal PD Reduction. | ≥7mm (Month 3: Change from Baseline) | NA millimeters |
| Other | Peridontal PD Reduction. | 6mm-7mm (Month 3: Change from Baseline) | NA millimeters |
| Other | Peridontal PD Reduction. | 5mm-6mm (Month 3: Change from Baseline) | -1.8 millimeters |
Secondary
Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm)
Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean Periodontal PD change from baseline will be measured in all sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
Time frame: At 3 months
Population: The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements). The Other reporting group, which included one subject, was not included in this analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| IQOS | Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) | -0.972 millimeters |
| Cigarette | Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) | -1.016 millimeters |
| Dual User | Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) | -1.035 millimeters |
Comparison: Month 3: Difference between Cigarette and IQOSp-value: 0.50295% CI: [-0.084, 0.171]Mixed Models Analysis
Comparison: Month 3: Difference between Cigarette and Dual Usep-value: 0.85195% CI: [-0.229, 0.189]Mixed Models Analysis
Secondary
Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics
Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean Periodontal PD change from baseline will be measured in all sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
Time frame: From baseline to 3 months and 6 months
Population: The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| IQOS | Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics | Month 6 | 3.36 millimeters |
| IQOS | Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics | Baseline | 4.45 millimeters |
| IQOS | Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics | Month 3 | 3.44 millimeters |
| Cigarette | Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics | Month 3 | 3.47 millimeters |
| Cigarette | Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics | Baseline | 4.43 millimeters |
| Cigarette | Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics | Month 6 | 3.37 millimeters |
| Dual User | Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics | Month 3 | 4.34 millimeters |
| Dual User | Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics | Baseline | 4.34 millimeters |
| Dual User | Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics | Month 6 | 3.29 millimeters |
| Other | Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics | Baseline | 4.07 millimeters |
| Other | Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics | Month 6 | 3.09 millimeters |
| Other | Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics | Month 3 | 3.04 millimeters |
Secondary
Presence of Plaque on Tooth Surfaces in Full Mouth
Plaque will be measured using the plaque control record (PCR) percentage.
Time frame: From baseline to 3 months and 6 months
Population: The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| IQOS | Presence of Plaque on Tooth Surfaces in Full Mouth | Month 6 | 49.60 Plaque Control Record % |
| IQOS | Presence of Plaque on Tooth Surfaces in Full Mouth | Month 3 | 48.03 Plaque Control Record % |
| IQOS | Presence of Plaque on Tooth Surfaces in Full Mouth | Month 6: Change from Baseline | -13.27 Plaque Control Record % |
| IQOS | Presence of Plaque on Tooth Surfaces in Full Mouth | Month 3: Change from Baseline | -14.27 Plaque Control Record % |
| IQOS | Presence of Plaque on Tooth Surfaces in Full Mouth | Baseline | 62.07 Plaque Control Record % |
| Cigarette | Presence of Plaque on Tooth Surfaces in Full Mouth | Month 3: Change from Baseline | -12.34 Plaque Control Record % |
| Cigarette | Presence of Plaque on Tooth Surfaces in Full Mouth | Month 6 | 51.55 Plaque Control Record % |
| Cigarette | Presence of Plaque on Tooth Surfaces in Full Mouth | Month 6: Change from Baseline | -11.22 Plaque Control Record % |
| Cigarette | Presence of Plaque on Tooth Surfaces in Full Mouth | Month 3 | 50.14 Plaque Control Record % |
| Cigarette | Presence of Plaque on Tooth Surfaces in Full Mouth | Baseline | 62.48 Plaque Control Record % |
| Dual User | Presence of Plaque on Tooth Surfaces in Full Mouth | Month 3: Change from Baseline | -11.25 Plaque Control Record % |
| Dual User | Presence of Plaque on Tooth Surfaces in Full Mouth | Baseline | 55.81 Plaque Control Record % |
| Dual User | Presence of Plaque on Tooth Surfaces in Full Mouth | Month 3 | 44.56 Plaque Control Record % |
| Dual User | Presence of Plaque on Tooth Surfaces in Full Mouth | Month 6 | 47.92 Plaque Control Record % |
| Dual User | Presence of Plaque on Tooth Surfaces in Full Mouth | Month 6: Change from Baseline | -7.89 Plaque Control Record % |
| Other | Presence of Plaque on Tooth Surfaces in Full Mouth | Month 6 | 58.04 Plaque Control Record % |
| Other | Presence of Plaque on Tooth Surfaces in Full Mouth | Month 3 | 60.71 Plaque Control Record % |
| Other | Presence of Plaque on Tooth Surfaces in Full Mouth | Baseline | 77.68 Plaque Control Record % |
| Other | Presence of Plaque on Tooth Surfaces in Full Mouth | Month 3: Change from Baseline | -16.96 Plaque Control Record % |
| Other | Presence of Plaque on Tooth Surfaces in Full Mouth | Month 6: Change from Baseline | -19.64 Plaque Control Record % |
Secondary
Tooth Mobility
Tooth mobility will be graded according to Miller's mobility index (MMI), which is the most widely accepted method for routine clinical examinations of tooth mobility. The tooth is held between the metallic handles of two instruments and moved in the buccolingual or buccopalatal direction, and the moved distance is visually estimated by the person conducting the examination. Grade 0: Physiologic movement within 0.2 mm; Grade 1: Slight mobility, tooth can be moved 0.2 - 1 mm labiolingually; Grade 2: Moderate mobility, tooth can be moved 1 - 2 mm labiolingually or mesiodistally; Grade 3: Severe mobility, tooth can be moved more than 2 mm labiolingually or mesiodistally, or ability to depress the tooth in a vertical direction.
Time frame: From baseline to 3 months and 6 months
Population: The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| IQOS | Tooth Mobility | Month 3: Change from Baseline | -0.01 MMI |
| IQOS | Tooth Mobility | Baseline | 0.18 MMI |
| IQOS | Tooth Mobility | Month 6: Change from Baseline | 0.00 MMI |
| IQOS | Tooth Mobility | Month 6 | 0.18 MMI |
| IQOS | Tooth Mobility | Month 3 | 0.17 MMI |
| Cigarette | Tooth Mobility | Month 3 | 0.16 MMI |
| Cigarette | Tooth Mobility | Month 3: Change from Baseline | -0.03 MMI |
| Cigarette | Tooth Mobility | Month 6 | 0.17 MMI |
| Cigarette | Tooth Mobility | Month 6: Change from Baseline | -0.02 MMI |
| Cigarette | Tooth Mobility | Baseline | 0.19 MMI |
| Dual User | Tooth Mobility | Month 3 | 0.19 MMI |
| Dual User | Tooth Mobility | Month 6 | 0.16 MMI |
| Dual User | Tooth Mobility | Baseline | 0.23 MMI |
| Dual User | Tooth Mobility | Month 6: Change from Baseline | -0.07 MMI |
| Dual User | Tooth Mobility | Month 3: Change from Baseline | -0.04 MMI |
| Other | Tooth Mobility | Month 3: Change from Baseline | 0.00 MMI |
| Other | Tooth Mobility | Month 6: Change from Baseline | 0.00 MMI |
| Other | Tooth Mobility | Month 6 | 0 MMI |
| Other | Tooth Mobility | Month 3 | 0 MMI |
| Other | Tooth Mobility | Baseline | 0 MMI |
Secondary
Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking.
Self-reported use of tobacco or nicotine containing products will be measured over the study in patients switching to IQOS use and patients who continue cigarette smoking.
Time frame: From baseline to 6 months
Population: The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment analyzed by actual product use. Results were reported only for subjects with exposure to a specific tobacco or nicotine-containing product.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| IQOS | Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking. | E-cigarettes/day | 2.67 number of product units consumed |
| IQOS | Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking. | Cigarettes/day over the last five years (Baseline) | 18.2 number of product units consumed |
| IQOS | Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking. | IQOS Heatsticks/day | 16.60 number of product units consumed |
| IQOS | Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking. | Other Heat-Not-Burn/day | 1.67 number of product units consumed |
| IQOS | Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking. | Cigarettes/day | 0.22 number of product units consumed |
| Cigarette | Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking. | IQOS Heatsticks/day | 0.30 number of product units consumed |
| Cigarette | Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking. | Cigarettes/day over the last five years (Baseline) | 17.7 number of product units consumed |
| Cigarette | Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking. | Cigarettes/day | 17.06 number of product units consumed |
| Cigarette | Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking. | Other Heat-Not-Burn/day | 3.72 number of product units consumed |
| Cigarette | Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking. | Nicotine Replacement Therapy/day | 0.81 number of product units consumed |
| Dual User | Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking. | Cigarettes/day over the last five years (Baseline) | 18.1 number of product units consumed |
| Dual User | Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking. | Cigarettes/day | 8.16 number of product units consumed |
| Dual User | Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking. | IQOS Heatsticks/day | 9.06 number of product units consumed |
| Dual User | Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking. | Other Heat-Not-Burn/day | 0.01 number of product units consumed |
| Other | Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking. | Other Heat-Not-Burn/day | 30.00 number of product units consumed |
| Other | Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking. | Nicotine Replacement Therapy/day | 0.50 number of product units consumed |
| Other | Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking. | Cigarettes/day over the last five years (Baseline) | 20.0 number of product units consumed |