Trial · NCT02750943
Potential of Stannous Fluoride Toothpaste to Reduce Gum Disease
NCT02750943, Not applicable, Completed, GlaxoSmithKline; results first posted 2016-11-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Potential of Stannous Fluoride Toothpaste to Reduce Gum Disease. Trials, record NCT02750943. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02750943
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Potential of Stannous Fluoride Toothpaste to Reduce Gum Disease
- NCT number
- NCT02750943
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 253 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Gingivitis
- Interventions
- Stannous Fluoride, Sodium Monofluorophosphate
- First posted
- 2016-04-26
- Last updated
- 2017-10-26
- Results first posted
- 2016-11-11
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Bleeding Sites at Week 12 | Week 12 | Number of bleeding sites was measured as bleeding index (BI) via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth (7-7 in each arch). The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. Bleeding sites were assessed as the number of bleeding sites with a BI score of 1 or 2. |
| Secondary | Number of Bleeding Sites at Week 4 | Week 4 | Number of bleeding sites was measured as BI via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth (7-7 in each arch). The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. Bleeding sites were assessed as the number of bleeding sites with a BI score of 1 or 2. |
| Secondary | Bleeding Index (BI) at Week 4 and Week 12 | Week 4, Week 12 | BI was assessed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed |
| Secondary | Modified Gingival Index (MGI) at Week 4 and Week 12 | Week 4, Week 12 | MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. |
| Secondary | Number of Participants With Visible Blood in Expectorate (Presence [Trace, Substantial]/Absence) at Week4 and Week 12 | Week 4, Week 12 | Visible blood in expectorate for each participant was classified as (i) Present (Trace or Substantial) (ii) Absent. The number of participants with blood 'Present' (Trace or Substantial) or 'absent' in expectorate was analyzed. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Bleeding Sites at Week 12 | Week 12 | Intent to treat (ITT) population which included all participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. Number of participants analyzed is the number of participants from ITT population evaluated for this outcome at Week 12 for respective treatment arm. | number of bleeding sites | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Bleeding Sites at Week 4 | Week 4 | Intent to treat (ITT) population which included all participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. Number of participants analyzed is the number of participants from ITT population evaluated for this outcome at Week 4 for respective treatment arm. | number of bleeding sites | LEAST_SQUARES_MEAN |
| SECONDARY | Bleeding Index (BI) at Week 4 and Week 12 | Week 4, Week 12 | Intent to treat (ITT) population which included all participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. Number of participants analyzed is the number of participants from ITT population evaluated for this outcome at specific time points for respective treatment arm. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Modified Gingival Index (MGI) at Week 4 and Week 12 | Week 4, Week 12 | Intent to treat (ITT) population which included all participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. Number of participants analyzed is the number of participants from ITT population evaluated for this outcome at specific time points for respective treatment arm. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Visible Blood in Expectorate (Presence [Trace, Substantial]/Absence) at Week4 and Week 12 | Week 4, Week 12 | Intent to treat (ITT) population which included all participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. Number of participants analyzed is the number of participants from ITT population evaluated for this outcome at specific time points for respective treatment arm. | number of participants | NUMBER |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Bleeding Sites at Week 12 | Stannous Fluoride | 42.02 | Standard Error 1.91 | number of bleeding sites | |
| Number of Bleeding Sites at Week 12 | Sodium Monofluorophosphate | 67.36 | Standard Error 1.91 | number of bleeding sites | |
| Number of Bleeding Sites at Week 4 | Stannous Fluoride | 45.44 | Standard Error 1.92 | number of bleeding sites | |
| Number of Bleeding Sites at Week 4 | Sodium Monofluorophosphate | 68.30 | Standard Error 1.91 | number of bleeding sites | |
| Bleeding Index (BI) at Week 4 and Week 12 | Stannous Fluoride | BI at Week 4 (n=121, 122) | 0.29 | Standard Error 0.01 | score on a scale |
| Bleeding Index (BI) at Week 4 and Week 12 | Sodium Monofluorophosphate | BI at Week 4 (n=121, 122) | 0.44 | Standard Error 0.01 | score on a scale |
| Bleeding Index (BI) at Week 4 and Week 12 | Stannous Fluoride | BI at Week 12 (n=119, 119) | 0.27 | Standard Error 0.01 | score on a scale |
| Bleeding Index (BI) at Week 4 and Week 12 | Sodium Monofluorophosphate | BI at Week 12 (n=119, 119) | 0.43 | Standard Error 0.01 | score on a scale |
| Modified Gingival Index (MGI) at Week 4 and Week 12 | Stannous Fluoride | MGI at Week 4 | 2.27 | Standard Error 0.01 | score on a scale |
| Modified Gingival Index (MGI) at Week 4 and Week 12 | Sodium Monofluorophosphate | MGI at Week 4 | 2.40 | Standard Error 0.01 | score on a scale |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stannous Fluoride | 125 | |
| Overall Study | STARTED | Sodium Monofluorophosphate | 128 | |
| Overall Study | COMPLETED | Stannous Fluoride | 119 | |
| Overall Study | COMPLETED | Sodium Monofluorophosphate | 119 | |
| Overall Study | NOT COMPLETED | Stannous Fluoride | 6 | |
| Overall Study | NOT COMPLETED | Sodium Monofluorophosphate | 9 |
Source ClinicalTrials.gov
Adverse events20
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 | Oral hyperkeratosis | Gastrointestinal disorders | Stannous Fluoride | 15 | 125 | |
| other | Oral hyperkeratosis | Gastrointestinal disorders | Sodium Monofluorophosphate | 19 | 128 | |
| other | Gingival pain | Gastrointestinal disorders | Stannous Fluoride | 2 | 125 | |
| other | Gingival pain | Gastrointestinal disorders | Sodium Monofluorophosphate | 0 | 128 | |
| other | Nausea | Gastrointestinal disorders | Stannous Fluoride | 0 | 125 | |
| other | Nausea | Gastrointestinal disorders | Sodium Monofluorophosphate | 1 | 128 | |
| other | Face Injury | Injury, poisoning and procedural complications | Stannous Fluoride | 0 | 125 | |
| other | Face Injury | Injury, poisoning and procedural complications | Sodium Monofluorophosphate | 1 | 128 | |
| other | Gingival injury | Injury, poisoning and procedural complications | Stannous Fluoride | 1 | 125 | |
| other | Gingival injury | Injury, poisoning and procedural complications | Sodium Monofluorophosphate | 0 | 128 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stannous Fluoride | ||
| Total, all-cause mortality | Sodium Monofluorophosphate | ||
| Total, other adverse events | Stannous Fluoride | 20 | 125 |
| Total, other adverse events | Sodium Monofluorophosphate | 22 | 128 |
| Total, serious adverse events | Stannous Fluoride | 0 | 125 |
| Total, serious adverse events | Sodium Monofluorophosphate | 0 | 128 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Stannous Fluoride vs Sodium Monofluorophosphate: serious adverse events |
Source 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/NCT02750943
GET https://conductscience.org/api/trials/v1/NCT02750943/results?page=2