Trial · NCT04123665
A Phase 3 Clinical Study Investigating the Gingivitis Efficacy of a Test Dentifrice Containing Stannous Fluoride
NCT04123665, Phase 3, Completed, GlaxoSmithKline; results first posted 2020-01-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 3 Clinical Study Investigating the Gingivitis Efficacy of a Test Dentifrice Containing Stannous Fluoride. Trials, record NCT04123665. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04123665
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Clinical Study Investigating the Gingivitis Efficacy of a Test Dentifrice Containing Stannous Fluoride
- NCT number
- NCT04123665
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 98 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Gingivitis
- Interventions
- Stannous fluoride, Sodium monofluorophosphate
- First posted
- 2019-10-11
- Last updated
- 2020-01-31
- Results first posted
- 2020-01-31
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluation and Comparison of Gingival Health Measured by Bleeding Index (BI) at 24 Weeks | At Week 24 | BI-to assess bleeding elicited on probing as a measure of gingival condition. Gingivae were air dried and examiner assessed bleeding using a probe which was gently inserted into gingival crevice to depth of approximately(app)1millimeter(mm)and run around tooth(angle of app60\[degrees(deg)\] to long axis of tooth), gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium. BI assessed on facial and lingual gingival surfaces of each scorable tooth(7in each arch). 3scores were recorded buccally/labially,3scores lingually/palatally. All scorable teeth in one quadrant were probed first(app30seconds\[sec\])before recording number of gingival units which bled. Values presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values(i.e.,0-2).BI score:0=no bleeding after30sec,1=bleeding upon probing after30sec,2=immediate bleeding observed. Lower scores indicate better results. |
| Secondary | Evaluation and Comparison of Gingival Health Measured by BI at 12 Weeks | At Week 12 | BI-to assess bleeding elicited on probing as a measure of gingival condition. Gingivae were air dried and examiner assessed bleeding using a probe which was gently inserted into gingival crevice to depth of app 1 mm and run around tooth (angle of app 60 deg to long axis of tooth), gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium. BI assessed on facial and lingual gingival surfaces of each scorable tooth (7in each arch). 3 scores were recorded buccally/ labially, 3scores lingually/ palatally. All scorable teeth in one quadrant were probed first (app 30 sec) before recording number of gingival units which bled. Values presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e.,0-2). BI score:0=no bleeding after 30 sec, 1=bleeding upon probing after 30 sec,2=immediate bleeding observed. Lower scores indicate better results. |
| Secondary | Evaluation and Comparison of Gingival Health Measured by BI Indices in Low MGI Subgroups (<=2.00) After 12 and 24 Weeks | At Week 12 and Week 24 | BI-to assess bleeding elicited on probing as measure of gingival condition.Gingivae were air dried,examiner assessed bleeding using probe gently inserted into gingival crevice to depth of app.1mm and run around tooth(at angle of app.60deg to long axis of tooth),gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium.BI assessed on facial,lingual gingival surfaces of each scorable tooth(7in each arch).3scores recorded buccally/labially and 3lingually/palatally. All scorable teeth in 1quadrant probed first(app.30sec)before recording number of gingival units which bled.Participants stratified based upon gender and baseline MGI score(Low:\<=2.00,High: \>2.00).Whole mouth mean of BI calculated by-taking average overall tooth sites assessed;to compare magnitude of differences in two strata.BI scoring:0=no bleeding after 30sec,1=bleeding upon probing after 30sec,2=immediate bleeding observed. Lower scores- better results. |
| Secondary | Evaluation and Comparison of Gingival Health Measured by BI Indices in High MGI Subgroup (>2.00) at 12 and 24 Weeks | At Week 12 and Week 24 | BI-to assess bleeding elicited on probing as measure of gingival condition.Gingivae were air dried,examiner assessed bleeding using probe gently inserted into gingival crevice to depth of app.1mm and run around tooth(at angle of app.60deg to long axis of tooth),gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium.BI assessed on facial,lingual gingival surfaces of each scorable tooth(7in each arch).3scores recorded buccally/labially and 3lingually/palatally. All scorable teeth in 1quadrant probed first(app.30sec)before recording number of gingival units which bled.Participants stratified based upon gender and baseline MGI score(Low:\<=2.00,High: \>2.00).Whole mouth mean of BI calculated by-taking average overall tooth sites assessed;to compare magnitude of differences in two strata.BI scoring:0=no bleeding after 30sec,1=bleeding upon probing after 30sec,2=immediate bleeding observed. Lower scores- better results. |
| Secondary | Evaluation and Comparison of Gingival Health Measured by Modified Gingival Index (MGI) at 12 and 24 Weeks | At Week 12 and Week 24 | MGI- to assess visual symptoms of gingivitis on facial and lingual surfaces of each scorable tooth (7 in each arch). 2scores recorded buccally/labially, 2scores lingually/palatally. Values presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e.,0-4). Scoring was performed using standard dental light: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 plus the entire marginal or papillar gingival unit,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. Lower scores indicate better results. |
| Secondary | Evaluation and Comparison of Gingival Health Measured by MGI Indices in Low MGI Subgroup (<=2.00) at 12 and 24 Weeks | At Week 12 and Week 24 | MGI-to assess gingivitis symptoms on facial, lingual surfaces of each scorable tooth(7in each arch).2 scores recorded buccally/labially(papilla,margin),2lingually/palatally(papilla,margin).Participants stratified based upon gender and baseline MGI score(Low:\<=2.00,High:\>2.00).Whole mouth mean of MGI calculated by-taking average overall tooth sites assessed;to compare magnitude of differences in two strata.MGI scoring: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 plus the entire marginal or papillar gingival unit,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. Lower scores indicate better results. |
| Secondary | Evaluation and Comparison of Gingival Health Measured by MGI Indices in High MGI Subgroup (>2.00) at 12 and 24 Weeks | At Week 12 and Week 24 | MGI-to assess gingivitis symptoms on facial, lingual surfaces of each scorable tooth(7in each arch).2 scores recorded buccally/labially(papilla,margin),2lingually/palatally(papilla,margin).Participants stratified based upon gender and baseline MGI score(Low:\<=2.00,High:\>2.00).Whole mouth mean of MGI calculated by-taking average overall tooth sites assessed;to compare magnitude of differences in two strata.MGI scoring: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 plus the entire marginal or papillar gingival unit,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. Lower scores indicate better results. |
| Secondary | Evaluation and Comparison of Supra-gingival Plaque Levels Measured by Overall and Inter-proximal Plaque Index (PI) at 12 and 24 Weeks | At Week 12 and Week 24 | Turesky Modification of Quigley Hein Plaque Index-to assess plaque on all gradable teeth. Participants rinsed the plaque in dye solution of 5milliliters(mL)of solution for 10 sec, then expectorated and rinsed with 10 mL of water for 10 sec and then expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Values presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e.,0-5). Disclosed plaque scored as:0=no plaque, 1=slight flecks of plaque at the cervical margin of the tooth,2=a thin continuous band of plaque (1mm or smaller) at the cervical margin of the tooth, 3=a band of plaque wider than 1mm but covering less than 1/3 of the area, 4=plaque covering at least 1/3 but less than 2/3 of the area,5=plaque covering 2/3 or more of the crown of the tooth. Lower scores indicate better results. |
| Other | Number of Bleeding Sites After 12 and 24 Weeks | At Week 12 and Week 24 | Number of gingival bleeding sites were measured as part of bleeding index 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. For each participant, the scoring system used to measure bleeding sites is as follows: 0= no bleeding after 30 sec, 1= bleeding upon probing after 30 sec, 2= immediate bleeding observed. Lower bleeding sites indicate better results. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Evaluation and Comparison of Gingival Health Measured by Bleeding Index (BI) at 24 Weeks | At Week 24 | Intent-to-treat (ITT) population \[N=91\] included all participants who received study treatment and had at least one post-baseline efficacy measurement. Number analyzed in this outcome measure signifies those who were evaluated. | Score on scale | MEAN |
| SECONDARY | Evaluation and Comparison of Gingival Health Measured by BI at 12 Weeks | At Week 12 | ITT population \[N=91\] included all participants who were enrolled and randomly allocated to treatment and are analyzed in the groups to which they were randomized. | Score on scale | MEAN |
| SECONDARY | Evaluation and Comparison of Gingival Health Measured by BI Indices in Low MGI Subgroups (<=2.00) After 12 and 24 Weeks | At Week 12 and Week 24 | Analysis was performed on a subgroup of ITT population (included all participants who received study treatment and had at least one post-baseline efficacy measurement) that included participants with MGI \<=2.00 \[N=39\] . Number analyzed included participants with available data for each specified category. | Score on scale | MEAN |
| SECONDARY | Evaluation and Comparison of Gingival Health Measured by BI Indices in High MGI Subgroup (>2.00) at 12 and 24 Weeks | At Week 12 and Week 24 | Analysis was performed on a subgroup of ITT population (included all participants who received study treatment and had at least one post-baseline efficacy measurement) that included participants with MGI \>2.00 \[N=52\] . Number analyzed included participants with available data for each specified category. | Score on scale | MEAN |
| SECONDARY | Evaluation and Comparison of Gingival Health Measured by Modified Gingival Index (MGI) at 12 and 24 Weeks | At Week 12 and Week 24 | Analysis was performed on ITT population \[N=91\] which included all participants who received study treatment and had at least one post-baseline efficacy measurement. Number analyzed included participants with available data for each specified category. | Score on scale | MEAN |
| SECONDARY | Evaluation and Comparison of Gingival Health Measured by MGI Indices in Low MGI Subgroup (<=2.00) at 12 and 24 Weeks | At Week 12 and Week 24 | Analysis was performed on a subgroup of ITT population (included all participants who received study treatment and had at least one post-baseline efficacy measurement) that included participants with MGI \<=2.00 \[N=39\] . Number analyzed included participants with available data for each specified category. | Score on scale | MEAN |
| SECONDARY | Evaluation and Comparison of Gingival Health Measured by MGI Indices in High MGI Subgroup (>2.00) at 12 and 24 Weeks | At Week 12 and Week 24 | Analysis was performed on a subgroup of ITT population (included all participants who received study treatment and had at least one post-baseline efficacy measurement) that included participants with MGI \>2.00 \[N=52\] . Number analyzed included participants with available data for each specified category. | Score on scale | MEAN |
| SECONDARY | Evaluation and Comparison of Supra-gingival Plaque Levels Measured by Overall and Inter-proximal Plaque Index (PI) at 12 and 24 Weeks | At Week 12 and Week 24 | Analysis was performed on ITT population \[N=91\] which included all participants who received study treatment and had at least one post-baseline efficacy measurement. Number analyzed included participants with available data for each specified category. | Score on scale | MEAN |
| OTHER_PRE_SPECIFIED | Number of Bleeding Sites After 12 and 24 Weeks | At Week 12 and Week 24 | Analysis was performed on ITT population \[N=91\] which included all participants who received study treatment and had at least one post-baseline efficacy measurement. Number analyzed included participants with available data for each specified category. | Number of bleeding sites | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Evaluation and Comparison of Gingival Health Measured by Bleeding Index (BI) at 24 Weeks | Experimental Test Stannous Fluoride Dentifrice | 0.11 | Standard Deviation 0.094 | Score on scale | |
| Evaluation and Comparison of Gingival Health Measured by Bleeding Index (BI) at 24 Weeks | Control Sodium Monofluorophosphate Dentifrice | 0.19 | Standard Deviation 0.105 | Score on scale | |
| Evaluation and Comparison of Gingival Health Measured by BI at 12 Weeks | Experimental Test Stannous Fluoride Dentifrice | 0.11 | Standard Deviation 0.104 | Score on scale | |
| Evaluation and Comparison of Gingival Health Measured by BI at 12 Weeks | Control Sodium Monofluorophosphate Dentifrice | 0.23 | Standard Deviation 0.124 | Score on scale | |
| Evaluation and Comparison of Gingival Health Measured by BI Indices in Low MGI Subgroups (<=2.00) After 12 and 24 Weeks | Experimental Test Stannous Fluoride Dentifrice | At week 12 with baseline MGI <=2.00 | 0.11 | Standard Deviation 0.119 | Score on scale |
| Evaluation and Comparison of Gingival Health Measured by BI Indices in Low MGI Subgroups (<=2.00) After 12 and 24 Weeks | Control Sodium Monofluorophosphate Dentifrice | At week 12 with baseline MGI <=2.00 | 0.21 | Standard Deviation 0.093 | Score on scale |
| Evaluation and Comparison of Gingival Health Measured by BI Indices in Low MGI Subgroups (<=2.00) After 12 and 24 Weeks | Experimental Test Stannous Fluoride Dentifrice | At week 24 with baseline MGI <=2.00 | 0.10 | Standard Deviation 0.097 | Score on scale |
| Evaluation and Comparison of Gingival Health Measured by BI Indices in Low MGI Subgroups (<=2.00) After 12 and 24 Weeks | Control Sodium Monofluorophosphate Dentifrice | At week 24 with baseline MGI <=2.00 | 0.16 | Standard Deviation 0.082 | Score on scale |
| Evaluation and Comparison of Gingival Health Measured by BI Indices in High MGI Subgroup (>2.00) at 12 and 24 Weeks | Experimental Test Stannous Fluoride Dentifrice | At week 12 with baseline MGI >2.00 | 0.11 | Standard Deviation 0.094 | Score on scale |
| Evaluation and Comparison of Gingival Health Measured by BI Indices in High MGI Subgroup (>2.00) at 12 and 24 Weeks | Control Sodium Monofluorophosphate Dentifrice | At week 12 with baseline MGI >2.00 | 0.25 | Standard Deviation 0.144 | Score on scale |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Experimental Test Stannous Fluoride Dentifrice | 50 | |
| Overall Study | STARTED | Control Sodium Monofluorophosphate Dentifrice | 48 | |
| Overall Study | COMPLETED | Experimental Test Stannous Fluoride Dentifrice | 42 | |
| Overall Study | COMPLETED | Control Sodium Monofluorophosphate Dentifrice | 48 | |
| Overall Study | NOT COMPLETED | Experimental Test Stannous Fluoride Dentifrice | 8 | |
| Overall Study | NOT COMPLETED | Control Sodium Monofluorophosphate Dentifrice | 0 |
Source ClinicalTrials.gov
Adverse events2
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 | Mouth Ulceration | Gastrointestinal disorders | Experimental Test Stannous Fluoride Dentifrice | 0 | 50 | 0 |
| other | Mouth Ulceration | Gastrointestinal disorders | Control Sodium Monofluorophosphate Dentifrice | 1 | 48 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental Test Stannous Fluoride Dentifrice | 0 | 50 |
| Total, all-cause mortality | Control Sodium Monofluorophosphate Dentifrice | 0 | 48 |
| Total, other adverse events | Experimental Test Stannous Fluoride Dentifrice | 0 | 50 |
| Total, other adverse events | Control Sodium Monofluorophosphate Dentifrice | 1 | 48 |
| Total, serious adverse events | Experimental Test Stannous Fluoride Dentifrice | 0 | 50 |
| Total, serious adverse events | Control Sodium Monofluorophosphate Dentifrice | 0 | 48 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32216778 | 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 |
|---|---|
| Experimental Test Stannous Fluoride Dentifrice vs Control Sodium Monofluorophosphate Dentifrice: deaths from any cause | Trial comparisons |
| Experimental Test Stannous Fluoride Dentifrice vs Control Sodium Monofluorophosphate 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/NCT04123665
GET https://conductscience.org/api/trials/v1/NCT04123665/results?page=2