Halitosis
Conditions
Brief summary
The purpose of this study is to investigate the efficacy of an experimental dentifrice, containing 0.454 percent (%) stannous fluoride and 0.3% zinc chloride, to reduce oral malodor, compared to a marketed regular fluoride dentifrice after 3 weeks twice daily brushing in a population of clinically diagnosed gingivitis.
Detailed description
This will be a single center, single blind (to the examiners undertaking the oral malodor assessments), randomized (stratified by the participant's sex), controlled, two arm parallel study in volunteers with clinically diagnosed gingivitis and oral malodor. The study will evaluate the clinical efficacy of an experimental dentifrice containing 0.454% stannous fluoride and 0.3% zinc chloride to reduce oral malodor after 3 weeks of twice-daily use compared to a regular reference dentifrice. Sufficient participants will be screened to randomize approximately 106 participants to study treatment (approximately 53 per treatment group) to ensure approximately 100 evaluable participants complete the study.
Interventions
Dentifrice containing 0.454% stannous fluoride with 0.3% zinc chloride.
OTHERReference Dentifrice
Standard fluoride dentifrice containing 0.243% sodium fluoride.
Sponsors
HALEON
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed. * Participant who is willing and able to comply with scheduled visits, product usage requirements, study procedures and lifestyle restrictions. * Participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history (for example, a medical condition or medication confirmed to contribute to xerostomia),or upon oral examination, that would impact the participant's safety, wellbeing or the outcomes of the study, if they were to participate in the study, or affect the participant's ability to understand and follow study procedures and requirements. * Participant with generally good oral health that fulfil all of the following: 1. Having at least 20 natural (vital) teeth. 2. Good oral health without lesions in the oral cavity (including the tongue) that could interfere with the study evaluations. 3. Having clinically diagnosed, plaque-induced gingivitis defined as having 10-30% bleeding sites from the bleeding on probing assessment. 4. At Screening (Visit 1) and prior to brushing with assigned dentifrice at Baseline (Visit 2) participants must provide 2 samples of mouth air, which must have a mean hydrogen sulfide concentration greater than 150ppb. There must be less than or equal to (\<=)500ppb difference between the values measured at screening and baseline (pre-brushing). 5. At Baseline (Visit 2), prior to brushing with assigned dentifrice participants must provide a breath sample with a mean organoleptic score greater than or equal to (\>=)2.
Exclusion criteria
* Participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or an employee of the sponsor directly involved in the conduct of the study or a member of their immediate family. * Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days of study entry and/or during study participation or who has previously been enrolled in this study. * Participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study. * A Participant who is pregnant (self-reported) or intending to become pregnant during the study. * Participant who is breastfeeding. * Participant who habitually smokes, uses tobacco products or who vapes. * Participant with known or suspected intolerance or hypersensitivity to the study products or any of their stated ingredients (or closely related compounds). * Participant who is unwilling or, in the opinion of the investigator or medically qualified designee, unable to comply with the requirements and/or Lifestyle Considerations of the study. * Participant with a recent history (within the last year) of alcohol or other substance abuse. * General medical exclusions: 1. Participant with a medical history that may prevent the Participant from participating in the study until study conclusion. 2. Participant with, or having recent history of, bronchitis, tonsillitis or sinusitis (within 6 weeks) or any other systemic condition that can cause oral malodor for example, xerostomia, chronic acid reflux, Type 1 diabetes, Crohn's disease, celiac disease or liver/kidney conditions. 3. Participant with a significant infectious disease, such as hepatitis, COVID-19, flu, respiratory infection, tuberculosis, or any other condition which can be transmitted in saliva or salivary aerosols which, in the opinion of the examiner, could endanger the organoleptic assessors. 4. Participant with any condition that impacts gum health (for example, Type 2 Diabetes). * General medication exclusions: 1. Participant using any antibiotic medication within 14 days prior to screening or at any time during the study. 2. Participant using chlorhexidine, cetylpyridinium chloride (CPC) or stannous fluoride containing mouthwash or dentifrice within 14 days prior to Visit 2 or between Visit 2 and 3. 3. Participant taking medications which may impact oral mouth odor (for example, Diazepam, Alprazolam, Lorazepam and so on). * General oral exclusions: 1. Participant with orthodontic or prosthetic appliances (fixed or removable), including dental implants. 2. Participant having had professional dental cleaning (oral prophylaxis) within 3 months prior to the screening visit or at any time during the study. 3. Participant with signs of active periodontal disease (with probing depth greater than \[\>\]3 millimeter \[mm\]) or who is receiving or has received treatment for periodontal disease (including surgery) within 12 months of Screening. 4. Participant who has had oral surgery or tooth extraction within 6 weeks of the screening visit. 5. Participant who has dental conditions or disease under active dental treatment or requiring immediate treatment. 6. Participant with tongue or lip piercing. 7. Participant with Oral Soft Tissue (OST) examination findings at Screening which, in the opinion of the investigator, could interfere with the conduct of the study (for example, stomatitis, open sores, lesions, cavitied caries lesions, redness or swelling). 8. Participant who does not practice daily oral care. * Participant with oral malodor which, in the opinion of the investigator, is not expected to respond to treatment with an over-the-counter dentifrice. * Participant who, in the opinion of the investigator, should not participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Breath Organoleptic Scores | Baseline (Day 0, Pre-Brushing) and Week 3 (Pre-Brushing) | An organoleptic assessment was used to evaluate the oral odor and defined as a method that measures the strength of target odor and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The assessors evaluated the oral odor and scored from 0 (lowest score) to 5 (highest score), where 0= No appreciable odor, 1= Barely noticeable odor, 2= Slight but clearly noticeable odor, 3= Moderate odor, 4= Strong odor, 5= Extremely foul odor. Lower score indicates improvement. The change from Baseline was calculated as score at Week 3 (Pre-Brushing) minus score at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing). Analysis was performed using Analysis of Covariance (ANCOVA) method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Baseline (Day 0, Pre-Brushing) and Week 3 (Pre-Brushing) | The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately. The change from Baseline was calculated as value at Week 3 (Pre-Brushing) minus value at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing). |
| Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Breath Organoleptic Scores | Baseline (Week 3, Pre-Brushing) and Week 3 (1 Hour Post-Brushing) | An organoleptic assessment was used to evaluate the oral odor and defined as a method that measures the strength of target odor and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The assessors evaluated the oral odor and scored from 0 (lowest score) to 5 (highest score), where 0= No appreciable odor, 1= Barely noticeable odor, 2= Slight but clearly noticeable odor, 3= Moderate odor, 4= Strong odor, 5= Extremely foul odor. Lower score indicates improvement. The change from Baseline was calculated as score at Week 3 (1 Hour Post-Brushing) minus score at (Week 3, Pre-Brushing). Baseline was defined as Week 3 (Pre-Brushing). |
| Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Total VSC Concentration in Breath | Baseline (Day 0, Pre-Brushing) and Week 3 (1 Hour Post-Brushing) | The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately, and the adjusted mean of total VSCs concentration was reported. The change from Baseline was calculated as value at Week 3 (1 Hour Post-Brushing) minus value at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing). |
| Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post--Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Baseline (Day 0, Pre-Brushing) and Week 3 (1 Hour Post-Brushing) | The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately. The change from Baseline was calculated as value at Week 3 (1 Hour Post-Brushing) minus value at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing). |
| Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Breath Organoleptic Scores | Baseline (Day 0, Pre-Brushing) and Week 3 (1 Hour Post-Brushing) | An organoleptic assessment was used to evaluate the oral odor and defined as a method that measures the strength of target odor and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The assessors evaluated the oral odor and scored from 0 (lowest score) to 5 (highest score), where 0= No appreciable odor, 1= Barely noticeable odor, 2= Slight but clearly noticeable odor, 3= Moderate odor, 4= Strong odor, 5= Extremely foul odor. Lower score indicates improvement. The change from Baseline was calculated as score at Week 3 (1 Hour Post-Brushing) minus score at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing). |
| Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Total Volatile Sulfur Compounds (VSCs) Concentration in Breath | Baseline (Day 0, Pre-Brushing) and Week 3 (Pre-Brushing) | The VSCs concentration in breath sample was evaluated using OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methanethiol and dimethyl sulfide). The concentration values (in parts per billion \[ppb\]) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately, and the adjusted mean of total VSCs concentration was reported. The change from Baseline was calculated as value at Week 3 (Pre-Brushing) minus value at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing). |
| Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Baseline (Day 0, Pre-Brushing) and Day 0 (1 Hour Post-Brushing) | The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately. The change from Baseline was calculated as value at Day 0 (1 Hour Post-Brushing) minus value at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing). |
| Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Breath Organoleptic Scores | Baseline (Day 0, Pre-Brushing) and Day 0 (1 Hour Post-Brushing) | An organoleptic assessment was used to evaluate the oral odor and defined as a method that measures the strength of target odor and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The assessors evaluated the oral odor and scored from 0 (lowest score) to 5 (highest score), where 0= No appreciable odor, 1= Barely noticeable odor, 2= Slight but clearly noticeable odor, 3= Moderate odor, 4= Strong odor, 5= Extremely foul odor. Lower score indicates improvement. The change from Baseline was calculated as score at Day 0 (1 Hour Post-Brushing) minus score at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing). |
| Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Total VSC Concentration in Breath | Baseline (Week 3, Pre-Brushing) and Week 3 (1 Hour Post-Brushing) | The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately, and the adjusted mean of total VSCs concentration was reported. The change from Baseline was calculated as value at Week 3 (1 Hour Post-Brushing) minus value at Baseline (Week 3, Pre-Brushing). Baseline was defined as Week 3 (Pre-Brushing). |
| Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Baseline (Week 3, Pre-Brushing) and Week 3 (1 Hour Post-Brushing) | The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately. The change from Baseline was calculated as value at Week 3 (1 Hour Post-Brushing) minus value at Baseline (Week 3, Pre-Brushing). Baseline was defined as Week 3 (Pre-Brushing). |
| Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Total VSC Concentration in Breath | Baseline (Day 0, Pre-Brushing) and Day 0 (1 Hour Post-Brushing) | The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately, and the adjusted mean of total VSCs concentration was reported. The change from Baseline was calculated as value at Day 0 (1 Hour Post-Brushing) minus value at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing). |
Countries
United States
Participant flow
Recruitment details
All participants were recruited at a single center in United States of America (USA).
Pre-assignment details
A total of 104 participants were screened, enrolled and randomized (52 participants to the experimental dentifrice group and 52 participants to the reference dentifrice group) in the study, of which 101 participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Experimental Dentifrice In this arm, eligible participants applied a ribbon of experimental dentifrice (0.454% stannous fluoride with 0.3% zinc chloride) to the toothbrush head and brushed their teeth under supervision for one timed minute on Visit 2 (1 to 3 weeks after screening). One hour (+/-5 minutes) post-brushing, participants had their post-brushing assessments and were instructed to brush twice daily (for 1 minute, morning and evening) with experimental dentifrice for the next 3 weeks until their next visit (Visit 3). At Visit 3 (Week 3), participants received the experimental dentifrice and underwent pre-brushing and post-brushing assessments in the same manner as performed at the Visit 2. | 52 |
| Reference Dentifrice In this arm, eligible participants applied a ribbon of reference dentifrice (0.243% sodium fluoride) to the toothbrush head and brushed their teeth under supervision for one timed minute on Visit 2 (1 to 3 weeks after screening). One hour (+/-5 minutes) post-brushing, participants had their post-brushing assessments and were instructed to brush twice daily (for 1 minute, morning and evening) with reference dentifrice for the next 3 weeks until their next visit (Visit 3). At Visit 3 (Week 3), participants received the reference dentifrice and underwent pre-brushing and post-brushing assessments in the same manner as performed at the Visit 2. | 52 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Participant did not receive call or showed up for final visit | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Reference Dentifrice | Total | Experimental Dentifrice |
|---|---|---|---|
| Age, Continuous | 46.4 years STANDARD_DEVIATION 11.17 | 47.4 years STANDARD_DEVIATION 11.04 | 48.5 years STANDARD_DEVIATION 10.91 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 5 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 51 Participants | 99 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 19 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 43 Participants | 80 Participants | 37 Participants |
| Sex: Female, Male Female | 38 Participants | 76 Participants | 38 Participants |
| Sex: Female, Male Male | 14 Participants | 28 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 52 |
| other Total, other adverse events | 0 / 52 | 0 / 52 |
| serious Total, serious adverse events | 0 / 52 | 0 / 52 |
Outcome results
Primary
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Breath Organoleptic Scores
An organoleptic assessment was used to evaluate the oral odor and defined as a method that measures the strength of target odor and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The assessors evaluated the oral odor and scored from 0 (lowest score) to 5 (highest score), where 0= No appreciable odor, 1= Barely noticeable odor, 2= Slight but clearly noticeable odor, 3= Moderate odor, 4= Strong odor, 5= Extremely foul odor. Lower score indicates improvement. The change from Baseline was calculated as score at Week 3 (Pre-Brushing) minus score at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing). Analysis was performed using Analysis of Covariance (ANCOVA) method.
Time frame: Baseline (Day 0, Pre-Brushing) and Week 3 (Pre-Brushing)
Population: mlTT population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Breath Organoleptic Scores | -1.23 Score on a scale | Standard Error 0.146 |
| Reference Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Breath Organoleptic Scores | 0.07 Score on a scale | Standard Error 0.145 |
p-value: <0.000195% CI: [-1.71, -0.9]ANCOVA
Secondary
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Breath Organoleptic Scores
An organoleptic assessment was used to evaluate the oral odor and defined as a method that measures the strength of target odor and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The assessors evaluated the oral odor and scored from 0 (lowest score) to 5 (highest score), where 0= No appreciable odor, 1= Barely noticeable odor, 2= Slight but clearly noticeable odor, 3= Moderate odor, 4= Strong odor, 5= Extremely foul odor. Lower score indicates improvement. The change from Baseline was calculated as score at Day 0 (1 Hour Post-Brushing) minus score at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing).
Time frame: Baseline (Day 0, Pre-Brushing) and Day 0 (1 Hour Post-Brushing)
Population: mITT population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Breath Organoleptic Scores | -2.11 Score on a scale | Standard Error 0.098 |
| Reference Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Breath Organoleptic Scores | -0.56 Score on a scale | Standard Error 0.098 |
p-value: <0.000195% CI: [-1.83, -1.28]ANCOVA
Secondary
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath
The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately. The change from Baseline was calculated as value at Day 0 (1 Hour Post-Brushing) minus value at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing).
Time frame: Baseline (Day 0, Pre-Brushing) and Day 0 (1 Hour Post-Brushing)
Population: mITT population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Hydrogen Sulfide | -324.07 Parts per billion | Standard Error 50.984 |
| Experimental Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Methanethiol | -137.61 Parts per billion | Standard Error 14.737 |
| Experimental Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Dimethyl Sulfide | 31.79 Parts per billion | Standard Error 18.313 |
| Reference Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Hydrogen Sulfide | 17.30 Parts per billion | Standard Error 50.984 |
| Reference Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Methanethiol | -63.46 Parts per billion | Standard Error 14.737 |
| Reference Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Dimethyl Sulfide | 3.81 Parts per billion | Standard Error 18.313 |
p-value: <0.000195% CI: [-485.1, -197.64]ANCOVA
p-value: 0.000695% CI: [-115.62, -32.68]ANCOVA
p-value: 0.283495% CI: [-23.49, 79.45]ANCOVA
Secondary
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Total VSC Concentration in Breath
The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately, and the adjusted mean of total VSCs concentration was reported. The change from Baseline was calculated as value at Day 0 (1 Hour Post-Brushing) minus value at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing).
Time frame: Baseline (Day 0, Pre-Brushing) and Day 0 (1 Hour Post-Brushing)
Population: mITT population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Total VSC Concentration in Breath | -434.60 Parts per billion | Standard Error 67.213 |
| Reference Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Total VSC Concentration in Breath | -37.64 Parts per billion | Standard Error 67.213 |
p-value: <0.000195% CI: [-586.51, -207.41]ANCOVA
Secondary
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Breath Organoleptic Scores
An organoleptic assessment was used to evaluate the oral odor and defined as a method that measures the strength of target odor and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The assessors evaluated the oral odor and scored from 0 (lowest score) to 5 (highest score), where 0= No appreciable odor, 1= Barely noticeable odor, 2= Slight but clearly noticeable odor, 3= Moderate odor, 4= Strong odor, 5= Extremely foul odor. Lower score indicates improvement. The change from Baseline was calculated as score at Week 3 (1 Hour Post-Brushing) minus score at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing).
Time frame: Baseline (Day 0, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)
Population: mlTT population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Breath Organoleptic Scores | -2.55 Score on a scale | Standard Error 0.145 |
| Reference Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Breath Organoleptic Scores | -0.38 Score on a scale | Standard Error 0.143 |
p-value: <0.000195% CI: [-2.58, -1.77]ANCOVA
Secondary
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post--Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath
The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately. The change from Baseline was calculated as value at Week 3 (1 Hour Post-Brushing) minus value at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing).
Time frame: Baseline (Day 0, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)
Population: mlTT population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post--Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Hydrogen Sulfide | -507.84 Parts per billion | Standard Error 47.83 |
| Experimental Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post--Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Methanethiol | -176.69 Parts per billion | Standard Error 17.351 |
| Experimental Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post--Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Dimethyl Sulfide | -43.45 Parts per billion | Standard Error 18.568 |
| Reference Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post--Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Hydrogen Sulfide | 60.05 Parts per billion | Standard Error 47.348 |
| Reference Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post--Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Methanethiol | -71.30 Parts per billion | Standard Error 17.178 |
| Reference Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post--Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Dimethyl Sulfide | -5.42 Parts per billion | Standard Error 18.384 |
p-value: <0.000195% CI: [-703.03, -432.75]ANCOVA
p-value: <0.000195% CI: [-154.15, -56.62]ANCOVA
p-value: 0.149895% CI: [-90.04, 13.97]ANCOVA
Secondary
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Total VSC Concentration in Breath
The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately, and the adjusted mean of total VSCs concentration was reported. The change from Baseline was calculated as value at Week 3 (1 Hour Post-Brushing) minus value at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing).
Time frame: Baseline (Day 0, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)
Population: mlTT population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Total VSC Concentration in Breath | -733.17 Parts per billion | Standard Error 66.436 |
| Reference Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Total VSC Concentration in Breath | -11.59 Parts per billion | Standard Error 65.766 |
p-value: <0.000195% CI: [-909.31, -533.86]ANCOVA
Secondary
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath
The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately. The change from Baseline was calculated as value at Week 3 (Pre-Brushing) minus value at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing).
Time frame: Baseline (Day 0, Pre-Brushing) and Week 3 (Pre-Brushing)
Population: mlTT population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Hydrogen Sulfide | -348.60 Parts per billion | Standard Error 45.553 |
| Experimental Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Methanethiol | -118.88 Parts per billion | Standard Error 23.04 |
| Experimental Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Dimethyl Sulfide | -42.59 Parts per billion | Standard Error 16.234 |
| Reference Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Hydrogen Sulfide | 70.26 Parts per billion | Standard Error 45.093 |
| Reference Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Methanethiol | -9.97 Parts per billion | Standard Error 22.81 |
| Reference Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Dimethyl Sulfide | -16.42 Parts per billion | Standard Error 16.074 |
p-value: <0.000195% CI: [-547.56, -290.15]ANCOVA
p-value: 0.001295% CI: [-173.66, -44.15]ANCOVA
p-value: 0.256195% CI: [-71.64, 19.29]ANCOVA
Secondary
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Total Volatile Sulfur Compounds (VSCs) Concentration in Breath
The VSCs concentration in breath sample was evaluated using OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methanethiol and dimethyl sulfide). The concentration values (in parts per billion \[ppb\]) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately, and the adjusted mean of total VSCs concentration was reported. The change from Baseline was calculated as value at Week 3 (Pre-Brushing) minus value at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing).
Time frame: Baseline (Day 0, Pre-Brushing) and Week 3 (Pre-Brushing)
Population: mlTT population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Total Volatile Sulfur Compounds (VSCs) Concentration in Breath | -518.00 Parts per billion | Standard Error 68.469 |
| Reference Dentifrice | Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Total Volatile Sulfur Compounds (VSCs) Concentration in Breath | 51.64 Parts per billion | Standard Error 67.779 |
p-value: <0.000195% CI: [-763.11, -376.17]ANCOVA
Secondary
Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Breath Organoleptic Scores
An organoleptic assessment was used to evaluate the oral odor and defined as a method that measures the strength of target odor and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The assessors evaluated the oral odor and scored from 0 (lowest score) to 5 (highest score), where 0= No appreciable odor, 1= Barely noticeable odor, 2= Slight but clearly noticeable odor, 3= Moderate odor, 4= Strong odor, 5= Extremely foul odor. Lower score indicates improvement. The change from Baseline was calculated as score at Week 3 (1 Hour Post-Brushing) minus score at (Week 3, Pre-Brushing). Baseline was defined as Week 3 (Pre-Brushing).
Time frame: Baseline (Week 3, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)
Population: mlTT population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Dentifrice | Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Breath Organoleptic Scores | -1.49 Score on a scale | Standard Error 0.108 |
| Reference Dentifrice | Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Breath Organoleptic Scores | -0.29 Score on a scale | Standard Error 0.107 |
p-value: <0.000195% CI: [-1.52, -0.87]ANCOVA
Secondary
Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath
The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately. The change from Baseline was calculated as value at Week 3 (1 Hour Post-Brushing) minus value at Baseline (Week 3, Pre-Brushing). Baseline was defined as Week 3 (Pre-Brushing).
Time frame: Baseline (Week 3, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)
Population: mlTT population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Dentifrice | Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Hydrogen Sulfide | -210.39 Parts per billion | Standard Error 29.608 |
| Experimental Dentifrice | Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Methanethiol | -82.58 Parts per billion | Standard Error 16.472 |
| Experimental Dentifrice | Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Dimethyl Sulfide | -11.38 Parts per billion | Standard Error 18.47 |
| Reference Dentifrice | Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Hydrogen Sulfide | 39.94 Parts per billion | Standard Error 29.3 |
| Reference Dentifrice | Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Methanethiol | -37.05 Parts per billion | Standard Error 16.307 |
| Reference Dentifrice | Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | Dimethyl Sulfide | 21.31 Parts per billion | Standard Error 18.287 |
p-value: <0.000195% CI: [-335.35, -165.3]ANCOVA
p-value: 0.05595% CI: [-92.05, 0.99]ANCOVA
p-value: 0.212495% CI: [-84.36, 18.99]ANCOVA
Secondary
Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Total VSC Concentration in Breath
The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately, and the adjusted mean of total VSCs concentration was reported. The change from Baseline was calculated as value at Week 3 (1 Hour Post-Brushing) minus value at Baseline (Week 3, Pre-Brushing). Baseline was defined as Week 3 (Pre-Brushing).
Time frame: Baseline (Week 3, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)
Population: mlTT population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Dentifrice | Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Total VSC Concentration in Breath | -301.42 Parts per billion | Standard Error 47.053 |
| Reference Dentifrice | Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Total VSC Concentration in Breath | 21.33 Parts per billion | Standard Error 46.567 |
p-value: <0.000195% CI: [-457.27, -188.23]ANCOVA