Trial · NCT05654662
A Clinical Study Investigating the Effects of a Dentifrice Containing 67% Sodium Bicarbonate When Used Twice Daily for 12 Weeks on Gingivitis Treatment and Plaque Removal
NCT05654662, Not applicable, Completed, HALEON; results first posted 2025-01-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Clinical Study Investigating the Effects of a Dentifrice Containing 67% Sodium Bicarbonate When Used Twice Daily for 12 Weeks on Gingivitis Treatment and Plaque Removal. Trials, record NCT05654662. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05654662
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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 67% Sodium Bicarbonate When Used Twice Daily for 12 Weeks on Gingivitis Treatment and Plaque Removal
- NCT number
- NCT05654662
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 197 participants, actual
- Lead sponsor
- HALEON
- Conditions
- Gingivitis, Dental Plaque
- Interventions
- Corsodyl Original Dentifrice, Colgate Cavity Protection Dentifrice
- First posted
- 2022-12-16
- Last updated
- 2025-01-13
- Results first posted
- 2025-01-13
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 12 | Baseline and Week 12 | The number of bleeding sites was calculated using the bleeding index (BI) assessment. The BI was assessed for all evaluable surfaces (having two-thirds of the natural tooth surface gradable for the assessment) of the facial and lingual/palatal gingiva, 6 sites per tooth (mesiobuccal, buccal, and distobuccal; mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Evaluable tooth sites were probed, and gingival bleeding was assessed for approximately 30 seconds after probing. The number of bleeding sites 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 bleeding. |
| Secondary | Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 12 (Test Product Versus [vs.] Reference Product) | Baseline and Week 12 | The number of bleeding sites was calculated using the BI assessment. The BI was assessed for all evaluable surfaces (having two-thirds of the natural tooth surface gradable for the assessment) of the facial and lingual/palatal gingiva, 6 sites per tooth (mesiobuccal, buccal, and distobuccal; mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Evaluable tooth sites were probed, and gingival bleeding was assessed for approximately 30 seconds after probing. The number of bleeding sites 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 bleeding. |
| Secondary | Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 3 and Week 6 | Baseline, Week 3, and Week 6 | The number of bleeding sites was calculated using the BI assessment. The BI was assessed for all evaluable surfaces (having two-thirds of the natural tooth surface gradable for the assessment) of the facial and lingual/palatal gingiva, 6 sites per tooth (mesiobuccal, buccal, and distobuccal; mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Evaluable tooth sites were probed, and gingival bleeding was assessed for approximately 30 seconds after probing. The number of bleeding sites 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 bleeding. |
| Secondary | Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 3 and Week 6 (Test Product vs. Reference Product) | Baseline, Week 3, and Week 6 | The number of bleeding sites was calculated using the BI assessment. The BI was assessed for all evaluable surfaces (having two-thirds of the natural tooth surface gradable for the assessment) of the facial and lingual/palatal gingiva, 6 sites per tooth (mesiobuccal, buccal, and distobuccal; mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Evaluable tooth sites were probed, and gingival bleeding was assessed for approximately 30 seconds after probing. The number of bleeding sites 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 bleeding. |
| Secondary | Adjusted Mean Change From Baseline in Mean BI at Weeks 3, 6 and 12 | Baseline, Weeks 3, 6 and 12 | The BI was assessed for all evaluable surfaces (having two-thirds of the natural tooth surface gradable for the assessment) of the facial and lingual/palatal gingiva, 6 sites per tooth (mesiobuccal, buccal, and distobuccal; mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Evaluable tooth sites were probed, and gingival bleeding was assessed for approximately 30 seconds after probing and scored on a 3-point scale 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. Mean BI was calculated by taking the average over all tooth sites assessed for a participant. Lower score indicated better outcome. 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 bleeding. |
| Secondary | Adjusted Mean Change From Baseline in Mean BI at Weeks 3, 6 and 12 (Test Product vs. Reference Product) | Baseline, Weeks 3, 6 and 12 | The BI was assessed for all evaluable surfaces (having two-thirds of the natural tooth surface gradable for the assessment) of the facial and lingual/palatal gingiva, 6 sites per tooth (mesiobuccal, buccal, and distobuccal; mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Evaluable tooth sites were probed, and gingival bleeding was assessed for approximately 30 seconds after probing and scored on a 3-point scale 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. Mean BI was calculated by taking the average over all tooth sites assessed for a participant. Lower score indicated better outcome. 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 bleeding. |
| Secondary | Adjusted Mean Change From Baseline in Mean Mean Modified Gingival Index (MGI) at Weeks 3, 6 and 12 | 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 for all evaluable surfaces of facial and lingual/palatal gingiva,4 sites per 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 the 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 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. |
| Secondary | Adjusted Mean Change From Baseline in Mean 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 for all evaluable surfaces of facial and lingual/palatal gingiva,4 sites per 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 the 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 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. |
| Secondary | Adjusted Mean Change From Baseline in Mean Overall TPI (Turesky Plaque Index) at Weeks 3, 6 and 12 | Baseline, Weeks 3, 6 and 12 | TPI was used to assess plaque on the facial and lingual surfaces of each scorable tooth (7-7 in each arch). 3 scores were recorded facially(distal, body, mesial sites), and 3 scores were recorded lingually(distal, body, mesial sites). Plaque was first disclosed using a 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 millimeter\[mm\]) at the cervical margin; 3=Band of plaque wider than 1 mm but covering less than (\<)1/3 of the tooth surface; 4=Plaque covering greater than or equal to (\>=)1/3 but \<2/3 of the tooth surface; 5=Plaque covering \>=2/3 of the tooth surface. Mean overall TPI score=Average of TPI values over all tooth sites assessed for a participant. 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 Overall 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 (7-7 in each arch). 3 scores were recorded facially (distal, body, mesial sites), and 3 scores were recorded lingually (distal, body, mesial sites). Plaque was first disclosed using a 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 \<1/3 of the tooth surface; 4=Plaque covering \>=1/3 but \<2/3 of the tooth surface; 5=Plaque covering \>=2/3 of the tooth surface. Mean overall TPI score=Average of TPI values over all tooth sites assessed for a participant. 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). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
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 Number of Bleeding Sites at Week 12 | 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 Number of Bleeding Sites 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 Number of Bleeding Sites at Week 3 and Week 6 | 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 Number of Bleeding Sites 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 BI at Weeks 3, 6 and 12 | 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 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 Mean Mean Modified Gingival Index (MGI) at Weeks 3, 6 and 12 | 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 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 |
| SECONDARY | Adjusted Mean Change From Baseline in Mean Overall TPI (Turesky Plaque Index) at Weeks 3, 6 and 12 | 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 Overall 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 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group45
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 Number of Bleeding Sites at Week 12 | Test Product (Corsodyl Original Toothpaste) | -4.3 | Standard Error 1.44 | bleeding sites | |
| Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 12 (Test Product Versus [vs.] Reference Product) | Test Product (Corsodyl Original Toothpaste) | -4.3 | Standard Error 1.44 | bleeding sites | |
| Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 12 (Test Product Versus [vs.] Reference Product) | Reference Product (Colgate Cavity Protection Toothpaste) | 2.3 | Standard Error 1.42 | bleeding sites | |
| Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 3 and Week 6 | Test Product (Corsodyl Original Toothpaste) | Change from Baseline at Week 3 | -2.4 | Standard Error 1.02 | bleeding sites |
| Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 3 and Week 6 | Test Product (Corsodyl Original Toothpaste) | Change from Baseline at Week 6 | -2.4 | Standard Error 1.26 | bleeding sites |
| Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 3 and Week 6 (Test Product vs. Reference Product) | Test Product (Corsodyl Original Toothpaste) | Change from Baseline at Week 3 | -2.4 | Standard Error 1.02 | bleeding sites |
| Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 3 and Week 6 (Test Product vs. Reference Product) | Reference Product (Colgate Cavity Protection Toothpaste) | Change from Baseline at Week 3 | 1.4 | Standard Error 1.02 | bleeding sites |
| Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 3 and Week 6 (Test Product vs. Reference Product) | Test Product (Corsodyl Original Toothpaste) | Change from Baseline at Week 6 | -2.4 | Standard Error 1.26 | bleeding sites |
| Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 3 and Week 6 (Test Product vs. Reference Product) | Reference Product (Colgate Cavity Protection Toothpaste) | Change from Baseline at Week 6 | 2.9 | Standard Error 1.25 | bleeding sites |
| Adjusted Mean Change From Baseline in Mean BI at Weeks 3, 6 and 12 | Test Product (Corsodyl Original Toothpaste) | Change from Baseline at Week 3 | -0.04 | Standard Error 0.008 | score on a scale |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 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 (Corsodyl Original Toothpaste) | 94 | |
| Overall Study | STARTED | Reference Product (Colgate Cavity Protection Toothpaste) | 96 | |
| Overall Study | COMPLETED | Test Product (Corsodyl Original Toothpaste) | 92 | |
| Overall Study | COMPLETED | Reference Product (Colgate Cavity Protection Toothpaste) | 96 | |
| Overall Study | NOT COMPLETED | Test Product (Corsodyl Original Toothpaste) | 2 | |
| Overall Study | NOT COMPLETED | Reference Product (Colgate Cavity Protection Toothpaste) | 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 BLEEDING | Gastrointestinal disorders | Test Product (Corsodyl Original Toothpaste) | 0 | 94 | |
| other | GINGIVAL BLEEDING | Gastrointestinal disorders | Reference Product (Colgate Cavity Protection Toothpaste) | 1 | 96 | |
| other | TOOTHACHE | Gastrointestinal disorders | Test Product (Corsodyl Original Toothpaste) | 0 | 94 | |
| other | TOOTHACHE | Gastrointestinal disorders | Reference Product (Colgate Cavity Protection Toothpaste) | 1 | 96 | |
| other | VOMITING | Gastrointestinal disorders | Test Product (Corsodyl Original Toothpaste) | 0 | 94 | |
| other | VOMITING | Gastrointestinal disorders | Reference Product (Colgate Cavity Protection Toothpaste) | 1 | 96 | |
| other | GINGIVAL INJURY | Injury, poisoning and procedural complications | Test Product (Corsodyl Original Toothpaste) | 2 | 94 | |
| other | GINGIVAL INJURY | Injury, poisoning and procedural complications | Reference Product (Colgate Cavity Protection Toothpaste) | 0 | 96 | |
| other | MIGRAINE | Nervous system disorders | Test Product (Corsodyl Original Toothpaste) | 0 | 94 | |
| other | MIGRAINE | Nervous system disorders | Reference Product (Colgate Cavity Protection Toothpaste) | 1 | 96 |
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 (Corsodyl Original Toothpaste) | 0 | 94 |
| Total, all-cause mortality | Reference Product (Colgate Cavity Protection Toothpaste) | 0 | 96 |
| Total, other adverse events | Test Product (Corsodyl Original Toothpaste) | 2 | 94 |
| Total, other adverse events | Reference Product (Colgate Cavity Protection Toothpaste) | 4 | 96 |
| Total, serious adverse events | Test Product (Corsodyl Original Toothpaste) | 0 | 94 |
| Total, serious adverse events | Reference Product (Colgate Cavity Protection Toothpaste) | 0 | 96 |
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 (Corsodyl Original Toothpaste) vs Reference Product (Colgate Cavity Protection Toothpaste): deaths from any cause | Trial comparisons |
| Test Product (Corsodyl Original Toothpaste) vs Reference Product (Colgate Cavity Protection Toothpaste): 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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Read this trial from software.
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