Trial · NCT06143670
A Clinical Study Investigating the Effects of a Dentifrice Containing 0.454% Stannous Fluoride on Gingivitis Treatment and Plaque Reduction When Used Twice Daily for 12 Weeks
NCT06143670, Not applicable, Completed, HALEON; results first posted 2025-03-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Clinical Study Investigating the Effects of a Dentifrice Containing 0.454% Stannous Fluoride on Gingivitis Treatment and Plaque Reduction When Used Twice Daily for 12 Weeks. Trials, record NCT06143670. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06143670
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Study Investigating the Effects of a Dentifrice Containing 0.454% Stannous Fluoride on Gingivitis Treatment and Plaque Reduction When Used Twice Daily for 12 Weeks
- NCT number
- NCT06143670
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 159 participants, actual
- Lead sponsor
- HALEON
- Conditions
- Gingivitis
- Interventions
- Stannous fluoride toothpaste, Sodium fluoride toothpaste
- First posted
- 2023-11-22
- Last updated
- 2025-03-21
- Results first posted
- 2025-03-21
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adjusted Mean Change From Baseline in the Number of Bleeding Sites (NBS) at Week 12 | Baseline and Week 12 | The NBS were calculated using the bleeding index (BI) assessment. BI assesses the number of bleeding points elicited on probing as a measure of gingival condition. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth using PCP11.5B Hu-Friedy Qulix Color Coded probe. The probe was gently inserted into the gingival crevice to a depth of approximately 1 millimeter (mm) and then run around the tooth gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. NBS for each participant was calculated as the number of evaluable tooth sites with bleeding observed immediately on probing or within 30 seconds of probing. Change from Baseline was calculated by subtracting the Baseline value from the value at Week 12. Baseline was defined as Day 0. A negative change from Baseline indicated improvement in gingival condition. |
| Secondary | Adjusted Mean Change From Baseline in the NBS at Week 12 (Test Product Versus [vs.] Reference Product) | Baseline and Week 12 | The NBS were calculated using the BI assessment. BI assesses the number of bleeding points elicited on probing as a measure of gingival condition. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth using PCP11.5B Hu-Friedy Qulix Color Coded probe. The probe was gently inserted into the gingival crevice to a depth of approximately 1 mm and then run around the tooth gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. NBS for each participant was calculated as the number of evaluable tooth sites with bleeding observed immediately on probing or within 30 seconds of probing. Change from Baseline was calculated by subtracting the Baseline value from the value at Week 12. Baseline was defined as Day 0. A negative change from Baseline indicated improvement in gingival condition. |
| Secondary | Adjusted Mean Change From Baseline in the NBS at Week 3 and Week 6 (Test Product vs. Reference Product) | Baseline, Week 3 and Week 6 | The NBS were calculated using the BI assessment. BI assesses the number of bleeding points elicited on probing as a measure of gingival condition. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth using PCP11.5B Hu-Friedy Qulix Color Coded probe. The probe was gently inserted into the gingival crevice to a depth of approximately 1 mm and then run around the tooth gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. NBS for each participant was calculated as the number of evaluable tooth sites with bleeding observed immediately on probing or within 30 seconds of probing. Change from Baseline was calculated by subtracting the Baseline value from the value at each indicated timepoint. Baseline was defined as Day 0. A negative change from Baseline indicated improvement in gingival condition. |
| Secondary | Adjusted Mean Change From Baseline in Mean Overall Turesky Plaque Index (TPI) at Weeks 3, 6 and 12 (Test Product vs. Reference Product) | Baseline, Weeks 3, 6 and 12 | TPI was used to assess plaque on the facial and lingual surfaces of each scorable tooth. The plaque was first disclosed using a plaque disclosing dye solution, disclosed plaque was then scored on a 6-point scale ranging from 0 to 5, where 0=No plaque; 1=Separate flecks of plaque at the cervical margin; 2=Thin continuous band of plaque (up to 1 mm) at the cervical margin; 3=Band of plaque wider than 1 mm but covering less than one third of the tooth surface; 4=Plaque covering more than one third but less than two thirds of the tooth surface; 5=Plaque covering more than two thirds of the tooth surface. Overall TPI score for each participant=Sum of index values over all evaluable tooth sites (sites scored as 0 to 5), divided by the number of evaluable tooth sites and ranged from 0 to 5. Lower score=better outcome. Change from Baseline=Value at each indicated timepoint minus Baseline value. Baseline=Day 0. A negative change from Baseline indicated improvement (less plaque accumulation). |
| Secondary | Adjusted Mean Change From Baseline in Mean Interproximal TPI at Weeks 3, 6 and 12 (Test Product vs. Reference Product) | Baseline, Weeks 3, 6 and 12 | TPI was used to assess plaque on the facial and lingual surfaces of each scorable tooth. The plaque was first disclosed using a plaque disclosing dye solution and scored on a 6-point scale ranging from 0 to 5, where 0=No plaque; 1=Separate flecks of plaque at the cervical margin; 2=Thin continuous band of plaque (up to 1 mm) at the cervical margin; 3=Band of plaque wider than 1 mm but covering less than one third of the tooth surface; 4=Plaque covering more than one third but less than two thirds of the tooth surface; 5=Plaque covering more than two thirds of the tooth surface. Interproximal TPI score for each participant=Sum of index values over all evaluable distal and mesial tooth sites, divided by the number of evaluable distal and mesial tooth sites and ranged from 0 to 5. Lower score=better outcome. Change from Baseline=Value at each indicated timepoint minus Baseline value. Baseline=Day 0. A negative change from Baseline indicated improvement (less plaque accumulation). |
| Secondary | Adjusted Mean Change From Baseline in BI at Weeks 3, 6 and 12 (Test Product vs. Reference Product) | Baseline, Weeks 3, 6 and 12 | BI assesses the number of bleeding points elicited on probing as a measure of gingival condition. BI was assessed on the facial and lingual gingival surfaces of each scorable tooth using PCP11.5B Hu-Friedy Qulix Color Coded probe. Gingival bleeding was scored on a 3-points scale with scores ranging from 0 to 2, where 0=No bleeding after 30 seconds, 1=Bleeding observed within 30 seconds of probing, 2=Bleeding observed immediately on probing. BI score for each participant=sum of index values over all evaluable tooth sites (those scored as 0, 1, or 2), divided by the number of evaluable tooth sites. Lower score=better outcome. Change from Baseline was calculated by subtracting the Baseline value from the value at each indicated timepoint. Baseline=Day 0. A negative change from Baseline indicated improvement in gingival condition. |
| Secondary | Adjusted Mean Change From Baseline in Modified Gingival Index (MGI) at Weeks 3, 6 and 12 (Test Product vs. Reference Product) | Baseline, Weeks 3, 6 and 12 | MGI assessment is a non-invasive evaluation which focuses on visual symptoms of gingivitis (example, redness, texture, edema). MGI was assessed on facial and lingual surfaces of each scorable tooth and scored on a 5-point scale ranging from 0 to 4, where 0=Absence of inflammation; 1=Mild inflammation; slight change in color, little 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 the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Lower score indicated better outcome. Change from Baseline=Value at each indicated timepoint minus Baseline \[Day 0\] value. A negative change from Baseline indicated improvement in symptoms. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Adjusted Mean Change From Baseline in the Number of Bleeding Sites (NBS) at Week 12 | Baseline and Week 12 | Modified Intent-To-Treat (mITT) population included all randomized participants who completed at least one use of study product and had at least one post baseline clinical performance assessment. | bleeding sites | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in the NBS at Week 12 (Test Product Versus [vs.] Reference Product) | Baseline and Week 12 | mITT population. Here, overall number analyzed is defined as the number of participants with data available for analysis of this outcome measure. | bleeding sites | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in the NBS at Week 3 and Week 6 (Test Product vs. Reference Product) | Baseline, Week 3 and Week 6 | mITT population. Only those participants available at the indicated timepoints were analyzed. | bleeding sites | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Mean Overall Turesky Plaque Index (TPI) at Weeks 3, 6 and 12 (Test Product vs. Reference Product) | Baseline, Weeks 3, 6 and 12 | mITT population. Only those participants available at the indicated timepoints were analyzed. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Mean Interproximal TPI at Weeks 3, 6 and 12 (Test Product vs. Reference Product) | Baseline, Weeks 3, 6 and 12 | mITT Population. Only those participants available at the indicated timepoints were analyzed. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in BI at Weeks 3, 6 and 12 (Test Product vs. Reference Product) | Baseline, Weeks 3, 6 and 12 | mITT Population. Only those participants available at the indicated timepoints were analyzed. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Modified Gingival Index (MGI) at Weeks 3, 6 and 12 (Test Product vs. Reference Product) | Baseline, Weeks 3, 6 and 12 | mITT Population. Only those participants available at the indicated timepoints were analyzed. | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group31
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Adjusted Mean Change From Baseline in the Number of Bleeding Sites (NBS) at Week 12 | Test Product | -14.6 | Standard Error 0.99 | bleeding sites | |
| Adjusted Mean Change From Baseline in the NBS at Week 12 (Test Product Versus [vs.] Reference Product) | Test Product | -14.6 | Standard Error 0.99 | bleeding sites | |
| Adjusted Mean Change From Baseline in the NBS at Week 12 (Test Product Versus [vs.] Reference Product) | Reference Product (Negative Control) | 2.2 | Standard Error 0.98 | bleeding sites | |
| Adjusted Mean Change From Baseline in the NBS at Week 3 and Week 6 (Test Product vs. Reference Product) | Test Product | Change from Baseline at Week 3 | -14.8 | Standard Error 1.05 | bleeding sites |
| Adjusted Mean Change From Baseline in the NBS at Week 3 and Week 6 (Test Product vs. Reference Product) | Reference Product (Negative Control) | Change from Baseline at Week 3 | 1.2 | Standard Error 1.01 | bleeding sites |
| Adjusted Mean Change From Baseline in the NBS at Week 3 and Week 6 (Test Product vs. Reference Product) | Test Product | Change from Baseline at Week 6 | -16.7 | Standard Error 0.84 | bleeding sites |
| Adjusted Mean Change From Baseline in the NBS at Week 3 and Week 6 (Test Product vs. Reference Product) | Reference Product (Negative Control) | Change from Baseline at Week 6 | 0.9 | Standard Error 0.82 | bleeding sites |
| Adjusted Mean Change From Baseline in Mean Overall Turesky Plaque Index (TPI) at Weeks 3, 6 and 12 (Test Product vs. Reference Product) | Test Product | Change from Baseline at Week 3 | -0.30 | Standard Error 0.026 | score on a scale |
| Adjusted Mean Change From Baseline in Mean Overall Turesky Plaque Index (TPI) at Weeks 3, 6 and 12 (Test Product vs. Reference Product) | Reference Product (Negative Control) | Change from Baseline at Week 3 | -0.02 | Standard Error 0.025 | score on a scale |
| Adjusted Mean Change From Baseline in Mean Overall Turesky Plaque Index (TPI) at Weeks 3, 6 and 12 (Test Product vs. Reference Product) | Test Product | Change from Baseline at Week 6 | -0.29 | Standard Error 0.023 | score on a scale |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Test Product | 76 | |
| Overall Study | STARTED | Reference Product (Negative Control) | 76 | |
| Overall Study | COMPLETED | Test Product | 73 | |
| Overall Study | COMPLETED | Reference Product (Negative Control) | 75 | |
| Overall Study | NOT COMPLETED | Test Product | 3 | |
| Overall Study | NOT COMPLETED | Reference Product (Negative Control) | 1 |
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 | ORAL MUCOSAL EXFOLIATION | Gastrointestinal disorders | Test Product | 4 | 76 | |
| other | ORAL MUCOSAL EXFOLIATION | Gastrointestinal disorders | Reference Product (Negative Control) | 2 | 76 | |
| other | APHTHOUS ULCER | Gastrointestinal disorders | Test Product | 1 | 76 | |
| other | APHTHOUS ULCER | Gastrointestinal disorders | Reference Product (Negative Control) | 2 | 76 | |
| other | HYPERAESTHESIA TEETH | Gastrointestinal disorders | Test Product | 0 | 76 | |
| other | HYPERAESTHESIA TEETH | Gastrointestinal disorders | Reference Product (Negative Control) | 1 | 76 | |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Test Product | 0 | 76 | |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Reference Product (Negative Control) | 1 | 76 | |
| other | MOUTH INJURY | Injury, poisoning and procedural complications | Test Product | 0 | 76 | |
| other | MOUTH INJURY | Injury, poisoning and procedural complications | Reference Product (Negative Control) | 1 | 76 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Test Product | 0 | 76 |
| Total, all-cause mortality | Reference Product (Negative Control) | 0 | 76 |
| Total, other adverse events | Test Product | 5 | 76 |
| Total, other adverse events | Reference Product (Negative Control) | 7 | 76 |
| Total, serious adverse events | Test Product | 0 | 76 |
| Total, serious adverse events | Reference Product (Negative Control) | 0 | 76 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Test Product vs Reference Product (Negative Control): deaths from any cause | Trial comparisons |
| Test Product vs Reference Product (Negative Control): 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.
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