Gingivitis
Conditions
Brief summary
The aim of this study is to investigate the impact of a stannous fluoride containing toothpaste in reducing gingivitis when used twice daily for a maximum for 3 weeks, when compared to a standard sodium fluoride toothpaste (negative control).
Detailed description
This will be a single center, controlled, single blind (examiner blind), randomized, two-treatment arm, parallel design, clinical study in participants (aged 18-65 years), with good general health (non-smokers) and generalized mild-moderate plaque-induced gingivitis and greater than equal to (\>=) 20 natural teeth. The study consists of 4 study visits. At Visit 1, Screening, after signing informed consent, participants will be assessed for eligibility based on the inclusion/exclusion criteria and will undergo oral soft tissue (OST) and oral hard tissue (OHT) assessments. Participants will return between 1 and 28 days following the screening visit for the Visit 2, baseline where they will undergo, a full OST examination followed by assessments of gingival inflammation (MGI), gingival bleeding (BI) and supra-gingival plaque (TPI). Eligible participants will be stratified based on gender and baseline mean whole mouth MGI score (low: less than equal to (\<=) 2.00/High greater than (\>) 2.00), to ensure a balance of gingivitis across both treatment groups and then randomized to study product. All randomized participants will receive full mouth dental prophylaxis (followed by flossing) to remove sub and supra-gingival calculus, stain, plaque and debris from the teeth. All participants will enter the treatment period with no visible plaque (TPI=0). After all clinical assessments, participants will be instructed to brush for 1 timed minute at site with their assigned study product, after which they will be instructed to continue using this twice daily (morning and evening) for 2 weeks. After 2 weeks the participants will return to site for their Week 2 (Visit 3) assessments. They will then continue using their test dentifrice for a further week and will continue to record all brushing events in the diary provided, after which they will return for their Week 3 (Visit 4) assessments. All assessments will be carried out on the facial and lingual/palatal surfaces of each incisor, canine, pre-molar and molar, excluding third molars. After the Week 3 visit, study closeout procedures will take place and the participant may undergo an additional prophylaxis if it is deemed necessary by the examiner. Adverse events and incidents will be recorded from informed consent and at the end of each study visit.
Interventions
Participants will brush their teeth with Sensodyne Repair and Protect (containing 0.454% stannous fluoride) for 1 timed minute twice a day (morning and evening), for 3 weeks.
Participants will brush their teeth with Colgate Cavity Protection repair and protect (containing sodium fluoride) for 1 timed minute twice a day (morning and evening), for 3 weeks.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Single Blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
An individual must meet all the following inclusion criteria to be eligible for enrollment into the study: * 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 assessment is performed. * A participant who is willing and able to comply with scheduled visits, treatment plan and other study procedures. * A 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 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. * A participant at screening (Visit 1) with: a)at least 20 natural permanent teeth excluding 3rd molars; b)at least 40 evaluable surfaces (an evaluable surface is defined as having 2/3rds of the natural tooth surface gradable for the selected clinical indices. The following should not be included in the evaluable surface count- third molars; fully crowned/extensively restored, grossly carious, orthodontically banded/bonded or abutment teeth; surfaces with calculus deposits which, in the opinion of the clinical examiner, would interfere with the baseline assessments of the selected clinical indices); or c) participants with generalized mild-moderate plaque-induced gingivitis, in the opinion of the clinical examiner, as confirmed by visual examinations. * A participant at baseline (prior to dental prophylaxis, (Visit 2) with: a)ongoing hard tissue eligibility and, in the opinion of the clinical examiner, at least 40 evaluable surfaces; b) mean whole mouth Modified Gingival Index (MGI) greater than equal to (\>=) 1.75 to less than equal to (\<=) 2.30; c) mean whole mouth supra-gingival Turesky Plaque Index (TPI) score ≥ 1.5; d) ≥ 20 bleeding sites.
Exclusion criteria
An individual who meets any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Whole Mouth Mean Bleeding Index (BI) at Week 3 | Week 3 | BI method used to assess gingival bleeding as measure of gingival health for facial and lingual/palatal gingival surfaces of all evaluable teeth, six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Examiner inserted a round-end probe approximately(app.) 1millimeter(mm) into gingival sulcus (at app 60 degrees) and moved around tooth, from distal interproximal area to mesial interproximal area, gently stretching gingival epithelium. Gingival bleeding was assessed 30 seconds after probing. Assessments performed 1 quadrant at a time; BI scores recorded as per given scoring criteria: 0=absence of bleeding on probing,1=bleeding observed within 30 seconds of probing,2=bleeding observed immediately on probing. Lower scores indicate better results. Mean whole mouth BI score for each participant was derived from total BI score divided by number of tooth sites scored. Overall mean calculated for all participants was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Whole Mouth Mean Bleeding Index (BI) at Week 2 | Week 2 | BI method used to assess gingival bleeding as a measure of gingival health for facial and lingual/palatal gingival surfaces of all evaluable teeth, six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Examiner inserted a round-end probe app. 1 mm into gingival sulcus (at app. 60 degrees) and moved around tooth, from distal interproximal area to mesial interproximal area, gently stretching gingival epithelium. Gingival bleeding was assessed 30 seconds after probing. Assessments were performed 1 quadrant at a time; BI scores were recorded as per given scoring criteria: 0=absence of bleeding on probing,1=bleeding observed within 30 seconds of probing,2=bleeding observed immediately on probing. Lower scores indicate better results. Mean whole mouth BI score for each participant was derived from total BI score divided by number of tooth sites scored. Overall mean calculated for all participants was reported. |
| Mean Number of Bleeding Sites (NBS) at Week 2 and Week 3 | Week 2 and Week 3 | Number of bleeding sites were derived from the bleeding index (BI). BI method used to assess gingival bleeding as a measure of gingival health for facial and lingual/palatal gingival surfaces of all evaluable teeth, six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Examiner inserted a round-end probe app. 1 mm into gingival sulcus (at app. 60 degrees) and moved around tooth, from distal interproximal area to mesial interproximal area, gently stretching gingival epithelium. Gingival bleeding was assessed 30 seconds after probing. Assessments were performed 1 quadrant at a time; BI scores were recorded as per given scoring criteria: 0=absence of bleeding on probing,1=bleeding observed within 30 seconds of probing,2=bleeding observed immediately on probing. Lower scores indicate better results. A bleeding site was a site scored as 1 or 2. Mean of all bleeding sites was calculated and reported. |
| Mean Modified Gingival Index (MGI) at Week 2 and Week 3 | Week 2 and Week 3 | MGI used to assess for visual symptoms of gingivitis (redness, texture, edema) for all evaluable teeth, four sites per tooth (facial surface - papilla and margin; lingual/palatal surface - papilla and margin). MGI scores were recorded as per given scoring criteria: 0- Absence of inflammation, 1- Mild inflammation: slight change in color, little change in texture of any portion of marginal or papillary gingival unit, 2- Mild inflammation: criteria as \[1\] but involving entire marginal or papillary gingival unit, 3- Moderate inflammation: glazing, redness, edema, and/or hypertrophy of marginal or papillary gingival unit, 4- Severe inflammation: marked redness, edema and/or hypertrophy of marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Lower scores indicate better results. Mean whole mouth MGI score for each participant was derived from total MGI score divided by number of tooth sites scored. Overall mean calculated for all participants was reported. |
| Mean Overall Turesky Modification of the Quigley & Hein Plaque Index (TPI) Score at Week 2 and Week 3 | Week 2 and Week 3 | TPI assessed supra-gingival plaques on facial and lingual surfaces of all evaluable teeth. Each tooth divided into 3 areas;3 scores recorded facially (mesiofacial,facial,distofacial) and 3 scores lingually (mesiolingual,lingual,distolingual) generating a total of 6 scores per tooth. Plaque was identified using disclosing solution followed by rinsing with tap water(10 milliliters for 10 seconds) and scored as per given scoring criteria:0-no plaque,1-separate flecks of plaque at cervical margin,2-thin continuous band of plaque (up to 1mm) at cervical margin,3-band of plaque wider than 1mm but covering less than(\<)1/3 of tooth surface,4-plaque covering more than or equal to (\>=)1/3 but \<2/3 of tooth surface,5-plaque covering \>=2/3 of tooth surface. Lower scores indicate better results. Mean Overall TPI score for each participant was derived from total TPI score over all tooth sites divided by number of tooth sites scored. Overall mean calculated for all participants was reported. |
| Mean Interproximal Turesky Modification of the Quigley & Hein Plaque Index (TPI) at Week 2 and Week 3 | Week 2 and Week 3 | TPI assessed supra-gingival plaques on facial and lingual surfaces of all evaluable teeth. Each tooth was divided into 3 areas; 3 scores were recorded facially (mesiofacial,facial,distofacial) and 3 scores lingually (mesiolingual,lingual,distolingual) generating a total of 6 scores per tooth. Plaque was identified using disclosing solution followed by rinsing with tap water(10 milliliters for 10 seconds) and scored as per given scoring criteria: 0-no plaque,1-separate flecks of plaque at cervical margin,2-thin continuous band of plaque(up to 1 mm)at cervical margin,3-band of plaque wider than 1mm but covering \<1/3 of tooth surface,4-plaque covering \>=1/3 but \<2/3 of tooth surface,5-plaque covering \>=2/3 of tooth surface. Lower scores indicate better results. Mean Interproximal TPI score for each participant was derived from total TPI score over all interproximal tooth sites divided by number of interproximal tooth sites scored. Mean calculated for all participants was reported. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from one center in United States.
Pre-assignment details
A total of 154 participants were screened, of whom 130 were randomized for treatment, 17 were screen failures, 3 withdrew consent prior to randomization, and 4 were not randomized as sufficient participants were already enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Sensodyne Repair and Protect (Test Dentifrice) Participants randomized to this group brushed their teeth with Sensodyne Repair and Protect containing 0.454 % SnF2 (1100 ppm fluoride) for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit. | 65 |
| Colgate Cavity Protection (Negative Control Dentifrice) Participants randomized to this group brushed their teeth with Colgate Cavity Protection containing 1100 ppm fluoride as SMFP for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit. | 65 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Colgate Cavity Protection (Negative Control Dentifrice) | Total | Sensodyne Repair and Protect (Test Dentifrice) |
|---|---|---|---|
| Age, Continuous | 39.6 Years STANDARD_DEVIATION 12.48 | 39.4 Years STANDARD_DEVIATION 11.95 | 39.3 Years STANDARD_DEVIATION 11.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 34 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 96 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 10 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 34 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 11 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 32 Participants | 71 Participants | 39 Participants |
| Sex: Female, Male Female | 40 Participants | 79 Participants | 39 Participants |
| Sex: Female, Male Male | 25 Participants | 51 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 65 |
| other Total, other adverse events | 4 / 65 | 3 / 65 |
| serious Total, serious adverse events | 0 / 65 | 0 / 65 |
Outcome results
Primary
Whole Mouth Mean Bleeding Index (BI) at Week 3
BI method used to assess gingival bleeding as measure of gingival health for facial and lingual/palatal gingival surfaces of all evaluable teeth, six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Examiner inserted a round-end probe approximately(app.) 1millimeter(mm) into gingival sulcus (at app 60 degrees) and moved around tooth, from distal interproximal area to mesial interproximal area, gently stretching gingival epithelium. Gingival bleeding was assessed 30 seconds after probing. Assessments performed 1 quadrant at a time; BI scores recorded as per given scoring criteria: 0=absence of bleeding on probing,1=bleeding observed within 30 seconds of probing,2=bleeding observed immediately on probing. Lower scores indicate better results. Mean whole mouth BI score for each participant was derived from total BI score divided by number of tooth sites scored. Overall mean calculated for all participants was reported.
Time frame: Week 3
Population: Modified intent-to-treat (m-ITT) population was defined as all participants who were randomized, received at least one dose of the study treatments and provided at least one post-baseline assessment of efficacy. Here, number of participants analyzed indicates participants with available data for this outcome measure at specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Repair and Protect (Test Dentifrice) | Whole Mouth Mean Bleeding Index (BI) at Week 3 | 0.14 score on a scale | Standard Deviation 0.071 |
| Colgate Cavity Protection (Negative Control Dentifrice) | Whole Mouth Mean Bleeding Index (BI) at Week 3 | 0.20 score on a scale | Standard Deviation 0.066 |
p-value: <0.000195% CI: [-0.08, -0.04]ANCOVA
Secondary
Mean Interproximal Turesky Modification of the Quigley & Hein Plaque Index (TPI) at Week 2 and Week 3
TPI assessed supra-gingival plaques on facial and lingual surfaces of all evaluable teeth. Each tooth was divided into 3 areas; 3 scores were recorded facially (mesiofacial,facial,distofacial) and 3 scores lingually (mesiolingual,lingual,distolingual) generating a total of 6 scores per tooth. Plaque was identified using disclosing solution followed by rinsing with tap water(10 milliliters for 10 seconds) and scored as per given scoring criteria: 0-no plaque,1-separate flecks of plaque at cervical margin,2-thin continuous band of plaque(up to 1 mm)at cervical margin,3-band of plaque wider than 1mm but covering \<1/3 of tooth surface,4-plaque covering \>=1/3 but \<2/3 of tooth surface,5-plaque covering \>=2/3 of tooth surface. Lower scores indicate better results. Mean Interproximal TPI score for each participant was derived from total TPI score over all interproximal tooth sites divided by number of interproximal tooth sites scored. Mean calculated for all participants was reported.
Time frame: Week 2 and Week 3
Population: m-ITT population was defined as all participants who were randomized, received at least one dose of the study treatments and provided at least one post-baseline assessment of efficacy. Here, number analyzed indicates participants with available data at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensodyne Repair and Protect (Test Dentifrice) | Mean Interproximal Turesky Modification of the Quigley & Hein Plaque Index (TPI) at Week 2 and Week 3 | At Week 2 | 2.48 score on a scale | Standard Deviation 0.338 |
| Sensodyne Repair and Protect (Test Dentifrice) | Mean Interproximal Turesky Modification of the Quigley & Hein Plaque Index (TPI) at Week 2 and Week 3 | At Week 3 | 2.47 score on a scale | Standard Deviation 0.421 |
| Colgate Cavity Protection (Negative Control Dentifrice) | Mean Interproximal Turesky Modification of the Quigley & Hein Plaque Index (TPI) at Week 2 and Week 3 | At Week 2 | 2.90 score on a scale | Standard Deviation 0.279 |
| Colgate Cavity Protection (Negative Control Dentifrice) | Mean Interproximal Turesky Modification of the Quigley & Hein Plaque Index (TPI) at Week 2 and Week 3 | At Week 3 | 2.88 score on a scale | Standard Deviation 0.273 |
Secondary
Mean Modified Gingival Index (MGI) at Week 2 and Week 3
MGI used to assess for visual symptoms of gingivitis (redness, texture, edema) for all evaluable teeth, four sites per tooth (facial surface - papilla and margin; lingual/palatal surface - papilla and margin). MGI scores were recorded as per given scoring criteria: 0- Absence of inflammation, 1- Mild inflammation: slight change in color, little change in texture of any portion of marginal or papillary gingival unit, 2- Mild inflammation: criteria as \[1\] but involving entire marginal or papillary gingival unit, 3- Moderate inflammation: glazing, redness, edema, and/or hypertrophy of marginal or papillary gingival unit, 4- Severe inflammation: marked redness, edema and/or hypertrophy of marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Lower scores indicate better results. Mean whole mouth MGI score for each participant was derived from total MGI score divided by number of tooth sites scored. Overall mean calculated for all participants was reported.
Time frame: Week 2 and Week 3
Population: m-ITT population was defined as all participants who were randomized, received at least one dose of the study treatments and provided at least one post-baseline assessment of efficacy. Here, number analyzed indicates participants with available data at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensodyne Repair and Protect (Test Dentifrice) | Mean Modified Gingival Index (MGI) at Week 2 and Week 3 | At Week 2 | 2.08 score on a scale | Standard Deviation 0.142 |
| Sensodyne Repair and Protect (Test Dentifrice) | Mean Modified Gingival Index (MGI) at Week 2 and Week 3 | At Week 3 | 2.05 score on a scale | Standard Deviation 0.152 |
| Colgate Cavity Protection (Negative Control Dentifrice) | Mean Modified Gingival Index (MGI) at Week 2 and Week 3 | At Week 2 | 2.18 score on a scale | Standard Deviation 0.113 |
| Colgate Cavity Protection (Negative Control Dentifrice) | Mean Modified Gingival Index (MGI) at Week 2 and Week 3 | At Week 3 | 2.15 score on a scale | Standard Deviation 0.124 |
Secondary
Mean Number of Bleeding Sites (NBS) at Week 2 and Week 3
Number of bleeding sites were derived from the bleeding index (BI). BI method used to assess gingival bleeding as a measure of gingival health for facial and lingual/palatal gingival surfaces of all evaluable teeth, six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Examiner inserted a round-end probe app. 1 mm into gingival sulcus (at app. 60 degrees) and moved around tooth, from distal interproximal area to mesial interproximal area, gently stretching gingival epithelium. Gingival bleeding was assessed 30 seconds after probing. Assessments were performed 1 quadrant at a time; BI scores were recorded as per given scoring criteria: 0=absence of bleeding on probing,1=bleeding observed within 30 seconds of probing,2=bleeding observed immediately on probing. Lower scores indicate better results. A bleeding site was a site scored as 1 or 2. Mean of all bleeding sites was calculated and reported.
Time frame: Week 2 and Week 3
Population: m-ITT population was defined as all participants who were randomized, received at least one dose of the study treatments and provided at least one post-baseline assessment of efficacy. Here, number analyzed indicates participants with available data at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensodyne Repair and Protect (Test Dentifrice) | Mean Number of Bleeding Sites (NBS) at Week 2 and Week 3 | At Week 2 | 21.0 number of bleeding sites | Standard Deviation 10.14 |
| Sensodyne Repair and Protect (Test Dentifrice) | Mean Number of Bleeding Sites (NBS) at Week 2 and Week 3 | At Week 3 | 19.7 number of bleeding sites | Standard Deviation 10.17 |
| Colgate Cavity Protection (Negative Control Dentifrice) | Mean Number of Bleeding Sites (NBS) at Week 2 and Week 3 | At Week 3 | 28.0 number of bleeding sites | Standard Deviation 9.6 |
| Colgate Cavity Protection (Negative Control Dentifrice) | Mean Number of Bleeding Sites (NBS) at Week 2 and Week 3 | At Week 2 | 31.7 number of bleeding sites | Standard Deviation 10.93 |
Secondary
Mean Overall Turesky Modification of the Quigley & Hein Plaque Index (TPI) Score at Week 2 and Week 3
TPI assessed supra-gingival plaques on facial and lingual surfaces of all evaluable teeth. Each tooth divided into 3 areas;3 scores recorded facially (mesiofacial,facial,distofacial) and 3 scores lingually (mesiolingual,lingual,distolingual) generating a total of 6 scores per tooth. Plaque was identified using disclosing solution followed by rinsing with tap water(10 milliliters for 10 seconds) and scored as per given scoring criteria:0-no plaque,1-separate flecks of plaque at cervical margin,2-thin continuous band of plaque (up to 1mm) at cervical margin,3-band of plaque wider than 1mm but covering less than(\<)1/3 of tooth surface,4-plaque covering more than or equal to (\>=)1/3 but \<2/3 of tooth surface,5-plaque covering \>=2/3 of tooth surface. Lower scores indicate better results. Mean Overall TPI score for each participant was derived from total TPI score over all tooth sites divided by number of tooth sites scored. Overall mean calculated for all participants was reported.
Time frame: Week 2 and Week 3
Population: m-ITT population was defined as all participants who were randomized, received at least one dose of the study treatments and provided at least one post-baseline assessment of efficacy. Here, number analyzed indicates participants with available data at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensodyne Repair and Protect (Test Dentifrice) | Mean Overall Turesky Modification of the Quigley & Hein Plaque Index (TPI) Score at Week 2 and Week 3 | At Week 2 | 2.35 score on a scale | Standard Deviation 0.333 |
| Sensodyne Repair and Protect (Test Dentifrice) | Mean Overall Turesky Modification of the Quigley & Hein Plaque Index (TPI) Score at Week 2 and Week 3 | At Week 3 | 2.33 score on a scale | Standard Deviation 0.42 |
| Colgate Cavity Protection (Negative Control Dentifrice) | Mean Overall Turesky Modification of the Quigley & Hein Plaque Index (TPI) Score at Week 2 and Week 3 | At Week 3 | 2.76 score on a scale | Standard Deviation 0.303 |
| Colgate Cavity Protection (Negative Control Dentifrice) | Mean Overall Turesky Modification of the Quigley & Hein Plaque Index (TPI) Score at Week 2 and Week 3 | At Week 2 | 2.81 score on a scale | Standard Deviation 0.307 |
Secondary
Whole Mouth Mean Bleeding Index (BI) at Week 2
BI method used to assess gingival bleeding as a measure of gingival health for facial and lingual/palatal gingival surfaces of all evaluable teeth, six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Examiner inserted a round-end probe app. 1 mm into gingival sulcus (at app. 60 degrees) and moved around tooth, from distal interproximal area to mesial interproximal area, gently stretching gingival epithelium. Gingival bleeding was assessed 30 seconds after probing. Assessments were performed 1 quadrant at a time; BI scores were recorded as per given scoring criteria: 0=absence of bleeding on probing,1=bleeding observed within 30 seconds of probing,2=bleeding observed immediately on probing. Lower scores indicate better results. Mean whole mouth BI score for each participant was derived from total BI score divided by number of tooth sites scored. Overall mean calculated for all participants was reported.
Time frame: Week 2
Population: m-ITT population was defined as all participants who were randomized, received at least one dose of the study treatments and provided at least one post-baseline assessment of efficacy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Repair and Protect (Test Dentifrice) | Whole Mouth Mean Bleeding Index (BI) at Week 2 | 0.15 score on a scale | Standard Deviation 0.072 |
| Colgate Cavity Protection (Negative Control Dentifrice) | Whole Mouth Mean Bleeding Index (BI) at Week 2 | 0.22 score on a scale | Standard Deviation 0.073 |