Trial · NCT04050722
A Clinical Study Investigating the Efficacy of a Stannous Fluoride Dentifrice in Improving Gingival Health After Twice Daily Use for 3 Weeks
NCT04050722, Phase 4, Completed, GlaxoSmithKline; results first posted 2020-11-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Clinical Study Investigating the Efficacy of a Stannous Fluoride Dentifrice in Improving Gingival Health After Twice Daily Use for 3 Weeks. Trials, record NCT04050722. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04050722
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Study Investigating the Efficacy of a Stannous Fluoride Dentifrice in Improving Gingival Health After Twice Daily Use for 3 Weeks
- NCT number
- NCT04050722
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 130 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Gingivitis
- Interventions
- Sensodyne Repair and Protect, Colgate Cavity Protection
- First posted
- 2019-08-08
- Last updated
- 2020-11-19
- Results first posted
- 2020-11-19
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Whole Mouth Mean Bleeding Index (BI) at Week 3 | Week 3 | 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. | score on a scale | MEAN |
| SECONDARY | Whole Mouth Mean Bleeding Index (BI) at Week 2 | Week 2 | 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. | score on a scale | MEAN |
| SECONDARY | Mean Number of Bleeding Sites (NBS) at Week 2 and Week 3 | Week 2 and Week 3 | 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. | number of bleeding sites | MEAN |
| SECONDARY | Mean Modified Gingival Index (MGI) at Week 2 and Week 3 | Week 2 and Week 3 | 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. | score on a scale | MEAN |
| SECONDARY | Mean Overall Turesky Modification of the Quigley & Hein Plaque Index (TPI) Score at Week 2 and Week 3 | Week 2 and Week 3 | 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. | score on a scale | MEAN |
| SECONDARY | Mean Interproximal Turesky Modification of the Quigley & Hein Plaque Index (TPI) at Week 2 and Week 3 | Week 2 and Week 3 | 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. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Whole Mouth Mean Bleeding Index (BI) at Week 3 | Sensodyne Repair and Protect (Test Dentifrice) | 0.14 | Standard Deviation 0.071 | score on a scale | |
| Whole Mouth Mean Bleeding Index (BI) at Week 3 | Colgate Cavity Protection (Negative Control Dentifrice) | 0.20 | Standard Deviation 0.066 | score on a scale | |
| Whole Mouth Mean Bleeding Index (BI) at Week 2 | Sensodyne Repair and Protect (Test Dentifrice) | 0.15 | Standard Deviation 0.072 | score on a scale | |
| Whole Mouth Mean Bleeding Index (BI) at Week 2 | Colgate Cavity Protection (Negative Control Dentifrice) | 0.22 | Standard Deviation 0.073 | score on a scale | |
| Mean Number of Bleeding Sites (NBS) at Week 2 and Week 3 | Sensodyne Repair and Protect (Test Dentifrice) | At Week 2 | 21.0 | Standard Deviation 10.14 | number of bleeding sites |
| Mean Number of Bleeding Sites (NBS) at Week 2 and Week 3 | Colgate Cavity Protection (Negative Control Dentifrice) | At Week 2 | 31.7 | Standard Deviation 10.93 | number of bleeding sites |
| Mean Number of Bleeding Sites (NBS) at Week 2 and Week 3 | Sensodyne Repair and Protect (Test Dentifrice) | At Week 3 | 19.7 | Standard Deviation 10.17 | number of bleeding sites |
| Mean Number of Bleeding Sites (NBS) at Week 2 and Week 3 | Colgate Cavity Protection (Negative Control Dentifrice) | At Week 3 | 28.0 | Standard Deviation 9.60 | number of bleeding sites |
| Mean Modified Gingival Index (MGI) at Week 2 and Week 3 | Sensodyne Repair and Protect (Test Dentifrice) | At Week 2 | 2.08 | Standard Deviation 0.142 | score on a scale |
| Mean Modified Gingival Index (MGI) at Week 2 and Week 3 | Colgate Cavity Protection (Negative Control Dentifrice) | At Week 2 | 2.18 | Standard Deviation 0.113 | score on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sensodyne Repair and Protect (Test Dentifrice) | 65 | |
| Overall Study | STARTED | Colgate Cavity Protection (Negative Control Dentifrice) | 65 | |
| Overall Study | COMPLETED | Sensodyne Repair and Protect (Test Dentifrice) | 64 | |
| Overall Study | COMPLETED | Colgate Cavity Protection (Negative Control Dentifrice) | 65 | |
| Overall Study | NOT COMPLETED | Sensodyne Repair and Protect (Test Dentifrice) | 1 | |
| Overall Study | NOT COMPLETED | Colgate Cavity Protection (Negative Control Dentifrice) | 0 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gingival injury | Injury, poisoning and procedural complications | Sensodyne Repair and Protect (Test Dentifrice) | 1 | 65 | 1 |
| other | Gingival injury | Injury, poisoning and procedural complications | Colgate Cavity Protection (Negative Control Dentifrice) | 1 | 65 | 1 |
| other | Traumatic ulcer | Injury, poisoning and procedural complications | Sensodyne Repair and Protect (Test Dentifrice) | 2 | 65 | 2 |
| other | Traumatic ulcer | Injury, poisoning and procedural complications | Colgate Cavity Protection (Negative Control Dentifrice) | 0 | 65 | 0 |
| other | Dry mouth | Gastrointestinal disorders | Sensodyne Repair and Protect (Test Dentifrice) | 1 | 65 | 1 |
| other | Dry mouth | Gastrointestinal disorders | Colgate Cavity Protection (Negative Control Dentifrice) | 1 | 65 | 1 |
| other | Gingival ulceration | Gastrointestinal disorders | Sensodyne Repair and Protect (Test Dentifrice) | 0 | 65 | 0 |
| other | Gingival ulceration | Gastrointestinal disorders | Colgate Cavity Protection (Negative Control Dentifrice) | 1 | 65 | 3 |
| other | Angular cheilitis | Infections and infestations | Sensodyne Repair and Protect (Test Dentifrice) | 1 | 65 | 2 |
| other | Angular cheilitis | Infections and infestations | Colgate Cavity Protection (Negative Control Dentifrice) | 0 | 65 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sensodyne Repair and Protect (Test Dentifrice) | 0 | 65 |
| Total, all-cause mortality | Colgate Cavity Protection (Negative Control Dentifrice) | 0 | 65 |
| Total, other adverse events | Sensodyne Repair and Protect (Test Dentifrice) | 4 | 65 |
| Total, other adverse events | Colgate Cavity Protection (Negative Control Dentifrice) | 3 | 65 |
| Total, serious adverse events | Sensodyne Repair and Protect (Test Dentifrice) | 0 | 65 |
| Total, serious adverse events | Colgate Cavity Protection (Negative Control Dentifrice) | 0 | 65 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34511098 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sensodyne Repair and Protect (Test Dentifrice) vs Colgate Cavity Protection (Negative Control Dentifrice): deaths from any cause | Trial comparisons |
| Sensodyne Repair and Protect (Test Dentifrice) vs Colgate Cavity Protection (Negative Control Dentifrice): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04050722
GET https://conductscience.org/api/trials/v1/NCT04050722/registered