Dentin Sensitivity
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of the 0.454 percentage (%) weight/weight (w/w) stannous fluoride (SnF2) toothpastes for the relief of dentine hypersensitivity (DH) in China.
Detailed description
This study will be a single center, randomized, controlled, examiner-blind, 3 treatment arm, parallel group design study, stratified by maximum baseline Schiff sensitivity score (of the 2 selected 'test teeth'), with a treatment period of 12 weeks, to investigate the clinical efficacy of a SnF2 toothpaste for the relief of DH in a Chinese population. The SnF2 test dentifrice will be compared to commercialized negative and positive control toothpastes.
Interventions
Sensodyne Sensitivity & Gum toothpaste is containing 0.454% w/w SnF2.
Crest Cavity Protection Fresh Lime is containing 1150 parts per million (ppm) fluoride as Sodium fluoride (NaF).
Sensodyne Repair and Protect toothpaste is containing 5.0% w/w calcium sodium phosphosilicate (CSPS).
Sponsors
HALEON
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant 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 study procedures are performed. * Participant who is willing and able to understand and comply with scheduled visits, product usage requirements and other study procedures. * A participant in good general, oral and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements. * Participant who owns a smartphone with the WeChat application installed. * A participant who presents the following oral and dental inclusions will apply at Screening (Visit 1): 1. Self-reported history of tooth sensitivity lasting more than six months but not more than 10 years and experience DH symptoms at least 'once a week' or more frequently (as mentioned in Screening questionnaire). 2. Good general oral health, with a minimum of 20 natural teeth. 3. Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, with clinically confirmed DH. * Each eligible tooth must meet all of the following criteria: 1. Exposed dentine due to facial/cervical erosion, abrasion or gingival recession (EAR). 2. Modified Gingival Index (MGI) = 0 directly adjacent to the exposed dentine (i.e., the test area) only 3. Clinical mobility = 0. 4. DH as evidenced by qualifying levels of tactile and evaporative (air) sensitivity (tactile threshold less than or equal to \[\<=\] 20 g and Schiff sensitivity score more than or equal to \[\>=\] 2). * A participant who presents the following oral and dental inclusions will apply at Baseline (Visit 2): * All teeth identified at Screening (Visit 1) as eligible for Baseline assessments will be reassessed for tactile sensitivity first; eligible teeth with Baseline tactile threshold \<= 20g will then be re-assessed for evaporative (air) sensitivity. * Participants must have a minimum of two non-adjacent, accessible teeth (incisors, canines, pre-molars), preferably in different quadrants, with clinically confirmed DH as evidenced by qualifying levels of tactile and evaporative (air) sensitivity: 1. Tactile threshold \<= 20 g at Screening and Baseline 2. Schiff sensitivity score \>= 2 at Screening and Baseline. 3. VAS \>= 40 mm at Baseline. * The clinical examiner will select two 'test teeth' from those eligible teeth which meet the tactile threshold and Schiff sensitivity score criteria at both Screening and Baseline, and the VAS criterion at Baseline. * Each test tooth must demonstrate a consistent DH response to the evaporative (air) stimulus at both Screening and Baseline: 1. Screening Schiff sensitivity score = 2 and Baseline Schiff sensitivity score = 2 or Screening Schiff sensitivity score = 3 and Baseline Schiff sensitivity score = 3.
Exclusion criteria
* Participant who is an employee of the study site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the study site otherwise supervised by the investigator; or a sponsor employee directly involved in the conduct of the study or a member of their immediate family. * Participant who has participated in, or has participated in, other studies (including non-medicinal studies) involving investigational product(s) within 30 days of Screening (Visit 1). * Participant who is participating in, has participated in, a study evaluating a tooth desensitizing treatment within 8 weeks of Screening (Visit 1). * Participant who is using, or has used, an oral care product indicated for DH relief within 8 weeks of Screening (Visit 1). Participant will be required to bring their current oral care products to Visit 1 for staff to verify the absence of known anti-sensitivity ingredients and DH claims. * Participant who has had a professional de-sensitizing treatment within 8 weeks of Screening (Visit 1). * Participant who habitually rinses with water during toothbrushing (self-reported at Screening Visit 1). * Participant who seen to rinse with water while brushing with the acclimatization toothpaste during review of their brushing compliance videos at Baseline (Visit 2). * 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 unable to comply with product usage instructions or Lifestyle Considerations as described in the protocol. * Female participant who is pregnant or intending to become pregnant during the study (self-reported). * Female participant who is breastfeeding. * Participant with a recent history (within the last year) of alcohol and/or substance abuse. * 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. * Participant taking daily doses of medications or traditional herbal treatments which, in the opinion of the investigator or medically qualified designee, could interfere with their perception of pain. 1. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood altering and anti-inflammatory drugs. 2. Examples of herbal treatments include clove oil, olive oil or other treatments directly applied to the oral cavity for the treatment of oral health conditions. * Participant taking daily doses of a medication which, in the opinion of the investigator or medically qualified designee, is causing xerostomia. * Participant who requires antibiotic prophylaxis for dental procedures. * At Screening (Visit 1): participant who has taken antibiotics within 2 weeks of their Screening visit. * At Baseline (Visit 2): participant who has taken antibiotics within 2 weeks of their Baseline visit (during the acclimatisation period). * Participant who has had a professional or self-applied tooth bleaching procedure within 8 weeks of Screening (Visit 1). * Participant who has had dental prophylaxis within 4 weeks of Screening (Visit 1). * Participant who has had treatment for periodontal disease (including surgery) within 12 months of Screening (Visit 1). * Participant who has had scaling or root planning within 3 months of Screening (Visit 1). * Participant with a tongue or lip piercing. * Participant with, in the opinion of the investigator or medically qualified designee, gross periodontal disease. * Participant with evidence of gross intra-oral neglect or the need for extensive dental therapy. * Participant with a fixed or removable partial prosthesis which, in the opinion of the investigator or medically qualified designee, would impact study outcomes. * Participant with multiple dental implants which, in the opinion of the investigator or medically qualified designee, would impact study outcomes. * Participant with fixed or removable orthodontic braces/bands or a fixed orthodontic retainer. * Participant with specific dentition exclusions for Test Teeth are as follows: 1. Tooth with evidence of current or recent caries or reported treatment of decay within 12 months of Screening (Visit 1). 2. Tooth with exposed dentin but with deep, defective or facial restorations. 3. Tooth with full crown or veneer. 4. Tooth adjacent to a bridge abutment or crown which, in the opinion of the investigator or medically qualified designee, would impact study outcomes. 5. Sensitive tooth with contributing aetiologies other than erosion, abrasion or recession to exposed dentine. 6. Sensitive tooth, in the opinion of the investigator or medically qualified designee, not expected to respond to treatment with an anti-sensitivity toothpaste. * Participant who has previously been enrolled in this study. * Any participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice Versus [vs.] Negative Control) | Baseline and Week 12 | Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. Participant's response was scored using Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0-3 where 0=Participant did not respond to air stimulation; 1=Participant responded to air stimulus but did not request discontinuation of stimulus; 2=Participant responded to air stimulus and requested discontinuation or moved from stimulus; 3=Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. Higher score indicated worse outcome (more sensitivity). Change from Baseline was calculated by subtracting the Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A negative change from Baseline indicated improvement in sensitivity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Mean Change From Baseline in Visual Analog Scale (VAS) Score (Millimeters [mm]) (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice vs. Negative Control) | Baseline and Week 12 | Evaporative (air) sensitivity was assessed on the facial surfaces of the two test teeth selected by the examiner at Baseline by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant's response to the stimulus was evaluated using Schiff sensitivity scale with scores ranging from 0 (Participant did not respond to air stimulation) to 3 (Responded to stimulus, considered stimulus to be painful, requested discontinuation of the stimulus). Participants then rated the intensity of their response to the evaporative (air) stimulus using a 100 mm VAS with scores ranging from 0 mm (No discomfort) to 100 mm (Extreme discomfort; worst imaginable). Higher score indicated worse outcome (higher sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A negative change from Baseline indicated an improvement in sensitivity. |
| Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control) | Baseline and Week 6 | Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. Participant's response was scored using Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0-3 where 0=Participant did not respond to air stimulation; 1=Participant responded to air stimulus but did not request discontinuation of stimulus; 2=Participant responded to air stimulus and requested discontinuation or moved from stimulus; 3=Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. Higher score indicated worse outcome (more sensitivity). Change from Baseline was calculated by subtracting the Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A negative change from Baseline indicated improvement in sensitivity. |
| Adjusted Mean Change From Baseline in Tactile Threshold (g) (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control) | Baseline and Week 6 | Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the upper force setting was 20 g. Tactile threshold (g) was derived as the mean value for the two 'Test Teeth' selected by the examiner at Baseline. Higher tactile threshold indicated better outcome (less sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A positive change from Baseline indicated an improvement in sensitivity. |
| Adjusted Mean Change From Baseline in Tactile Threshold (Gram [g]) (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice vs. Negative Control) | Baseline and Week 12 | Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application of the stimulus, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the upper force setting was 20 g. Tactile threshold (g) was derived as the mean value for the two 'Test Teeth' selected by the examiner at Baseline. Higher tactile threshold indicated better outcome (less sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A positive change from Baseline indicated an improvement in sensitivity. |
| Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control) | Baseline, Week 6 and Week 12 | Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. Participant's response was scored using Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0-3 where 0=Participant did not respond to air stimulation; 1=Participant responded to air stimulus but did not request discontinuation of stimulus; 2=Participant responded to air stimulus and requested discontinuation or moved from stimulus; 3=Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. Higher score indicated worse outcome (more sensitivity). Change from Baseline was calculated by subtracting the Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A negative change from Baseline indicated improvement in sensitivity. |
| Adjusted Mean Change From Baseline in Tactile Threshold (g) (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control) | Baseline, Week 6 and Week 12 | Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application of the stimulus, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the upper force setting was 20 g. Tactile threshold (g) was derived as the mean value for the two 'Test Teeth' selected by the examiner at Baseline. Higher tactile threshold indicated better outcome (less sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A positive change from Baseline indicated an improvement. |
| Adjusted Mean Change From Baseline in VAS Score (mm) (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control) | Baseline, Week 6 and Week 12 | Evaporative (air) sensitivity was assessed on the facial surfaces of the two test teeth selected by the examiner at Baseline by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant's response to the stimulus was evaluated using Schiff sensitivity scale with scores ranging from 0(Participant did not respond to air stimulation) to 3(Responded to stimulus, considered stimulus to be painful, requested discontinuation of the stimulus). Participant then rated the intensity of their response to the evaporative (air) stimulus using a 100 mm VAS with scores ranging from 0 mm (No discomfort) to 100 mm (Extreme discomfort; worst imaginable). Higher score indicated worse outcome (higher sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A negative change from Baseline indicated an improvement in sensitivity. |
| Adjusted Mean Change From Baseline in VAS Score (mm) (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control) | Baseline and Week 6 | Evaporative (air) sensitivity was assessed on the facial surfaces of the two test teeth selected by the examiner at Baseline by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant's response to the stimulus was evaluated using Schiff sensitivity scale with scores ranging from 0 (Participant did not respond to air stimulation) to 3 (Responded to stimulus, considered stimulus to be painful, requested discontinuation of the stimulus). Participant then rated the intensity of their response to the evaporative (air) stimulus using a 100 mm VAS with scores ranging from 0 mm (No discomfort) to 100 mm (Extreme discomfort; worst imaginable). Higher score indicated worse outcome (higher sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A negative change from Baseline indicated an improvement in sensitivity. |
Countries
China
Participant flow
Recruitment details
This study was conducted at a single center in China.
Pre-assignment details
A total of 720 participants were screened of which 416 participants were enrolled and 243 participants were randomized to receive treatment in 3 groups - Test group (97 participants), Positive Control group (50 participants) and Negative Control group (96 participants). A total of 240 randomized participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Test Dentifrice (Sensodyne Sensitivity and Gum) Participants brushed the two test teeth first, then the whole mouth (all teeth) with Sensodyne Sensitivity and Gum toothpaste containing 0.454% w/w SnF2 for 1-timed minute, twice daily (morning and evening) for up to 12 weeks. After brushing, participants rinsed once with 10mL of water using the measuring cup provided. | 95 |
| Positive Control (Sensodyne Repair and Protect) Participants brushed the two test teeth first, then the whole mouth (all teeth) with Sensodyne Repair and Protect toothpaste containing 5.0% w/w CSPS for 1-timed minute, twice daily (morning and evening) for up to 12 weeks. After brushing, participants rinsed once with 10 mL of water using the measuring cup provided. | 49 |
| Negative Control (Crest Cavity Protection Fresh Lime) Participants brushed the two test teeth first, then the whole mouth (all teeth) with Crest Cavity Protection Fresh Lime toothpaste (regular fluoride toothpaste) for 1-timed minute, twice daily (morning and evening) for up to 12 weeks. After brushing, participants rinsed once with 10 mL of water using the measuring cup provided. | 96 |
| Total | 240 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Test Dentifrice (Sensodyne Sensitivity and Gum) | Positive Control (Sensodyne Repair and Protect) | Negative Control (Crest Cavity Protection Fresh Lime) | Total |
|---|---|---|---|---|
| Age, Continuous | 42.4 years STANDARD_DEVIATION 7.64 | 43.7 years STANDARD_DEVIATION 7.55 | 43.2 years STANDARD_DEVIATION 7.57 | 43.0 years STANDARD_DEVIATION 7.58 |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 95 Participants | 49 Participants | 96 Participants | 240 Participants |
| Sex: Female, Male Female | 89 Participants | 47 Participants | 88 Participants | 224 Participants |
| Sex: Female, Male Male | 6 Participants | 2 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 97 | 0 / 50 | 0 / 96 |
| other Total, other adverse events | 16 / 97 | 9 / 50 | 11 / 96 |
| serious Total, serious adverse events | 0 / 97 | 0 / 50 | 0 / 96 |
Outcome results
Primary
Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice Versus [vs.] Negative Control)
Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. Participant's response was scored using Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0-3 where 0=Participant did not respond to air stimulation; 1=Participant responded to air stimulus but did not request discontinuation of stimulus; 2=Participant responded to air stimulus and requested discontinuation or moved from stimulus; 3=Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. Higher score indicated worse outcome (more sensitivity). Change from Baseline was calculated by subtracting the Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A negative change from Baseline indicated improvement in sensitivity.
Time frame: Baseline and Week 12
Population: mITT population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Dentifrice (Sensodyne Sensitivity and Gum) | Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice Versus [vs.] Negative Control) | -0.90 score on a scale | Standard Error 0.068 |
| Negative Control (Crest Cavity Protection Fresh Lime) | Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice Versus [vs.] Negative Control) | -0.74 score on a scale | Standard Error 0.068 |
p-value: 0.087195% CI: [-0.36, 0.02]Mixed Model with Repeated Measure (MMRM)
Secondary
Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control)
Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. Participant's response was scored using Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0-3 where 0=Participant did not respond to air stimulation; 1=Participant responded to air stimulus but did not request discontinuation of stimulus; 2=Participant responded to air stimulus and requested discontinuation or moved from stimulus; 3=Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. Higher score indicated worse outcome (more sensitivity). Change from Baseline was calculated by subtracting the Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A negative change from Baseline indicated improvement in sensitivity.
Time frame: Baseline, Week 6 and Week 12
Population: mITT population. Only those participants with data available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Dentifrice (Sensodyne Sensitivity and Gum) | Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control) | Change from Baseline at Week 6 | -0.36 score on a scale | Standard Error 0.069 |
| Test Dentifrice (Sensodyne Sensitivity and Gum) | Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control) | Change from Baseline at Week 12 | -0.67 score on a scale | Standard Error 0.095 |
| Negative Control (Crest Cavity Protection Fresh Lime) | Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control) | Change from Baseline at Week 6 | -0.38 score on a scale | Standard Error 0.049 |
| Negative Control (Crest Cavity Protection Fresh Lime) | Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control) | Change from Baseline at Week 12 | -0.74 score on a scale | Standard Error 0.068 |
Comparison: Change from Baseline at Week 6p-value: 0.825695% CI: [-0.15, 0.19]MMRM
Comparison: Change from Baseline at Week 12p-value: 0.531495% CI: [-0.16, 0.3]MMRM
Secondary
Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control)
Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. Participant's response was scored using Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0-3 where 0=Participant did not respond to air stimulation; 1=Participant responded to air stimulus but did not request discontinuation of stimulus; 2=Participant responded to air stimulus and requested discontinuation or moved from stimulus; 3=Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. Higher score indicated worse outcome (more sensitivity). Change from Baseline was calculated by subtracting the Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A negative change from Baseline indicated improvement in sensitivity.
Time frame: Baseline and Week 6
Population: mITT population. Only those participants with data available at the indicated timepoint were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Dentifrice (Sensodyne Sensitivity and Gum) | Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control) | -0.51 score on a scale | Standard Error 0.049 |
| Negative Control (Crest Cavity Protection Fresh Lime) | Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control) | -0.38 score on a scale | Standard Error 0.049 |
p-value: 0.067395% CI: [-0.27, 0.01]MMRM
Secondary
Adjusted Mean Change From Baseline in Tactile Threshold (g) (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control)
Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application of the stimulus, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the upper force setting was 20 g. Tactile threshold (g) was derived as the mean value for the two 'Test Teeth' selected by the examiner at Baseline. Higher tactile threshold indicated better outcome (less sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A positive change from Baseline indicated an improvement.
Time frame: Baseline, Week 6 and Week 12
Population: mITT population. Only those participants with data available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Dentifrice (Sensodyne Sensitivity and Gum) | Adjusted Mean Change From Baseline in Tactile Threshold (g) (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control) | Change from Baseline at Week 6 | 6.77 grams | Standard Error 2.883 |
| Test Dentifrice (Sensodyne Sensitivity and Gum) | Adjusted Mean Change From Baseline in Tactile Threshold (g) (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control) | Change from Baseline at Week 12 | 18.53 grams | Standard Error 3.83 |
| Negative Control (Crest Cavity Protection Fresh Lime) | Adjusted Mean Change From Baseline in Tactile Threshold (g) (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control) | Change from Baseline at Week 6 | 9.36 grams | Standard Error 2.357 |
| Negative Control (Crest Cavity Protection Fresh Lime) | Adjusted Mean Change From Baseline in Tactile Threshold (g) (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control) | Change from Baseline at Week 12 | 19.65 grams | Standard Error 2.977 |
Comparison: Change from Baseline at Week 6p-value: 0.557595% CI: [-8.48, 3.3]van Elteren Test
Comparison: Change from Baseline at Week 12p-value: 0.771795% CI: [-9.6, 7.37]van Elteren Test
Secondary
Adjusted Mean Change From Baseline in Tactile Threshold (g) (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control)
Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the upper force setting was 20 g. Tactile threshold (g) was derived as the mean value for the two 'Test Teeth' selected by the examiner at Baseline. Higher tactile threshold indicated better outcome (less sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A positive change from Baseline indicated an improvement in sensitivity.
Time frame: Baseline and Week 6
Population: mITT population. Only those participants with data available at the indicated timepoint were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Dentifrice (Sensodyne Sensitivity and Gum) | Adjusted Mean Change From Baseline in Tactile Threshold (g) (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control) | 11.74 grams | Standard Error 2.393 |
| Negative Control (Crest Cavity Protection Fresh Lime) | Adjusted Mean Change From Baseline in Tactile Threshold (g) (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control) | 9.36 grams | Standard Error 2.357 |
p-value: 0.40595% CI: [-2.44, 7.2]van Elteren Test
Secondary
Adjusted Mean Change From Baseline in Tactile Threshold (Gram [g]) (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice vs. Negative Control)
Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application of the stimulus, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the upper force setting was 20 g. Tactile threshold (g) was derived as the mean value for the two 'Test Teeth' selected by the examiner at Baseline. Higher tactile threshold indicated better outcome (less sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A positive change from Baseline indicated an improvement in sensitivity.
Time frame: Baseline and Week 12
Population: mITT population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Dentifrice (Sensodyne Sensitivity and Gum) | Adjusted Mean Change From Baseline in Tactile Threshold (Gram [g]) (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice vs. Negative Control) | 25.86 grams | Standard Error 3.008 |
| Negative Control (Crest Cavity Protection Fresh Lime) | Adjusted Mean Change From Baseline in Tactile Threshold (Gram [g]) (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice vs. Negative Control) | 19.65 grams | Standard Error 2.977 |
p-value: 0.097295% CI: [-0.78, 13.2]van Elteren Test
Secondary
Adjusted Mean Change From Baseline in VAS Score (mm) (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control)
Evaporative (air) sensitivity was assessed on the facial surfaces of the two test teeth selected by the examiner at Baseline by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant's response to the stimulus was evaluated using Schiff sensitivity scale with scores ranging from 0(Participant did not respond to air stimulation) to 3(Responded to stimulus, considered stimulus to be painful, requested discontinuation of the stimulus). Participant then rated the intensity of their response to the evaporative (air) stimulus using a 100 mm VAS with scores ranging from 0 mm (No discomfort) to 100 mm (Extreme discomfort; worst imaginable). Higher score indicated worse outcome (higher sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A negative change from Baseline indicated an improvement in sensitivity.
Time frame: Baseline, Week 6 and Week 12
Population: mITT population. Only those participants with data available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Dentifrice (Sensodyne Sensitivity and Gum) | Adjusted Mean Change From Baseline in VAS Score (mm) (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control) | Change from Baseline at Week 6 | -15.53 score on a scale | Standard Error 3.123 |
| Test Dentifrice (Sensodyne Sensitivity and Gum) | Adjusted Mean Change From Baseline in VAS Score (mm) (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control) | Change from Baseline at Week 12 | -29.30 score on a scale | Standard Error 3.542 |
| Negative Control (Crest Cavity Protection Fresh Lime) | Adjusted Mean Change From Baseline in VAS Score (mm) (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control) | Change from Baseline at Week 6 | -16.28 score on a scale | Standard Error 2.556 |
| Negative Control (Crest Cavity Protection Fresh Lime) | Adjusted Mean Change From Baseline in VAS Score (mm) (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control) | Change from Baseline at Week 12 | -33.02 score on a scale | Standard Error 2.83 |
Comparison: Change from Baseline at Week 6p-value: 0.81895% CI: [-5.63, 7.12]MMRM
Comparison: Change from Baseline at Week 12p-value: 0.332295% CI: [-3.83, 11.28]MMRM
Secondary
Adjusted Mean Change From Baseline in VAS Score (mm) (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control)
Evaporative (air) sensitivity was assessed on the facial surfaces of the two test teeth selected by the examiner at Baseline by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant's response to the stimulus was evaluated using Schiff sensitivity scale with scores ranging from 0 (Participant did not respond to air stimulation) to 3 (Responded to stimulus, considered stimulus to be painful, requested discontinuation of the stimulus). Participant then rated the intensity of their response to the evaporative (air) stimulus using a 100 mm VAS with scores ranging from 0 mm (No discomfort) to 100 mm (Extreme discomfort; worst imaginable). Higher score indicated worse outcome (higher sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A negative change from Baseline indicated an improvement in sensitivity.
Time frame: Baseline and Week 6
Population: mITT population. Only those participants with data available at the indicated timepoint were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Dentifrice (Sensodyne Sensitivity and Gum) | Adjusted Mean Change From Baseline in VAS Score (mm) (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control) | -21.92 score on a scale | Standard Error 2.603 |
| Negative Control (Crest Cavity Protection Fresh Lime) | Adjusted Mean Change From Baseline in VAS Score (mm) (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control) | -16.28 score on a scale | Standard Error 2.556 |
p-value: 0.034695% CI: [-10.88, -0.41]MMRM
Secondary
Adjusted Mean Change From Baseline in Visual Analog Scale (VAS) Score (Millimeters [mm]) (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice vs. Negative Control)
Evaporative (air) sensitivity was assessed on the facial surfaces of the two test teeth selected by the examiner at Baseline by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant's response to the stimulus was evaluated using Schiff sensitivity scale with scores ranging from 0 (Participant did not respond to air stimulation) to 3 (Responded to stimulus, considered stimulus to be painful, requested discontinuation of the stimulus). Participants then rated the intensity of their response to the evaporative (air) stimulus using a 100 mm VAS with scores ranging from 0 mm (No discomfort) to 100 mm (Extreme discomfort; worst imaginable). Higher score indicated worse outcome (higher sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A negative change from Baseline indicated an improvement in sensitivity.
Time frame: Baseline and Week 12
Population: mITT population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Dentifrice (Sensodyne Sensitivity and Gum) | Adjusted Mean Change From Baseline in Visual Analog Scale (VAS) Score (Millimeters [mm]) (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice vs. Negative Control) | -38.84 score on a scale | Standard Error 2.872 |
| Negative Control (Crest Cavity Protection Fresh Lime) | Adjusted Mean Change From Baseline in Visual Analog Scale (VAS) Score (Millimeters [mm]) (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice vs. Negative Control) | -33.02 score on a scale | Standard Error 2.83 |
p-value: 0.067195% CI: [-12.04, 0.41]MMRM