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The main goal of this study is to evaluate and compare the efficacy of an on-market dentifrice containing 67 percent (%) sodium bicarbonate and 0.31% sodium fluoride to a reference regular fluoride dentifrice on treating gingival bleeding and gingival inflammation as well as reducing plaque accumulation in population with gingivitis after 12 weeks use.
This will be a single center, controlled, single blind (examiner blind), randomized, two treatment arm, parallel study in volunteers with clinically measurable levels of gingivitis (defined as those with 10-30% bleeding sites on probing). Approximately 200 participants (100 per group) will be randomized to ensure 188 evaluable participants (94 per group) complete the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corsodyl Original Dentifrice | Experimental | Participants will be instructed to brush their teeth using test product for at least a minute twice a day (morning and evening) for 12 weeks. Participants will dose the toothbrush provided with a ribbon of paste to cover the brush head (a full brush head) on each brushing occasion. |
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| Colgate Cavity Protection Dentifrice | Active Comparator | Participants will be instructed to brush their teeth using reference product for at least a minute twice a day (morning and evening) for 12 weeks. Participants will dose the toothbrush provided with a ribbon of paste to cover the brush head (a full brush head) on each brushing occasion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corsodyl Original Dentifrice | Drug | It contains 67% weight/weight (w/w) Sodium Bicarbonate and 0.310% w/w Sodium Fluoride (1400 parts per million [ppm] Fluoride ion [F]) |
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| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change From Baseline in Number of Bleeding Sites at 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. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 12 (Test Product Versus [vs.] Reference Product) | 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. |
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Inclusion Criteria:
At Screening (Visit 1):
At Baseline (Visit 2):
Exclusion Criteria:
Medication Exclusions At Screening (Visit 1):
Medication Exclusions at Baseline (visit 2):
Periodontal Exclusions
Dental Exclusions
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bristol, Bristol Dental School and Hospital | Bristol | BS1 2LY | United Kingdom |
Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.
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A total of 204 participants were screened of which 197 participants were enrolled, and 190 participants were randomized to receive treatment in 2 groups: Test Product group (94 participants) and Reference Product group (96 participants). 14 participants were not randomized (9 participants did not meet study criteria; 2 participants were lost to follow-up; and 3 participants withdrew their consent). A total of 188 randomized participants completed the study.
This study was conducted at a single center in the United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Product (Corsodyl Original Toothpaste) | Participants were instructed to dose the toothbrush provided with full ribbon of test product (Corsodyl Original Toothpaste) containing 67 percent (%) weight/weight (w/w) Sodium Bicarbonate and 0.310% w/w Sodium Fluoride and brush their teeth for at least a minute, twice daily (morning and evening) for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 10, 2023 | Nov 20, 2024 |
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| Colgate Cavity Protection Dentifrice | Drug | It contains 0.76% w/w Sodium Monofluorophosphate (1000 ppm F) and 0.1% w/w Sodium Fluoride (450 ppm F) |
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| Baseline and Week 12 |
| Adjusted Mean Change From Baseline in Number of Bleeding Sites at 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. | Baseline, Week 3, and Week 6 |
| Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 3 and Week 6 (Test Product vs. Reference Product) | 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. | Baseline, Week 3, and Week 6 |
| Adjusted Mean Change From Baseline in Mean BI at 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. | Baseline, Weeks 3, 6 and 12 |
| Adjusted Mean Change From Baseline in Mean BI at Weeks 3, 6 and 12 (Test Product vs. Reference Product) | 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. | Baseline, Weeks 3, 6 and 12 |
| Adjusted Mean Change From Baseline in Mean Mean Modified Gingival Index (MGI) at 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. | Baseline, Weeks 3, 6 and 12 |
| Adjusted Mean Change From Baseline in Mean MGI at Weeks 3, 6 and 12 (Test Product vs. Reference Product) | 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. | Baseline, Weeks 3, 6 and 12 |
| Adjusted Mean Change From Baseline in Mean Overall TPI (Turesky Plaque Index) at 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). | Baseline, Weeks 3, 6 and 12 |
| Adjusted Mean Change From Baseline in Mean Overall TPI at Weeks 3, 6 and 12 (Test Product vs. Reference Product) | 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). | Baseline, Weeks 3, 6 and 12 |
| Adjusted Mean Change From Baseline in Mean Interproximal TPI at 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, mesial sites), and 3 scores were recorded lingually (distal, 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 interproximal TPI score=Average of TPI values over distal and mesial tooth sites assessed for a participant. Lower score indicated 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). | Baseline, Weeks 3, 6 and 12 |
| Adjusted Mean Change From Baseline in Mean Interproximal TPI at Weeks 3, 6 and 12 (Test Product vs. Reference Product) | 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, mesial sites), and 3 scores were recorded lingually (distal, 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 interproximal TPI score=Average of TPI values over distal and mesial tooth sites assessed for a participant. Lower score indicated 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). | Baseline, Weeks 3, 6 and 12 |
| FG001 |
| Reference Product (Colgate Cavity Protection Toothpaste) |
Participants were instructed to dose the toothbrush provided with full ribbon of reference product (Colgate Cavity Protection Toothpaste) containing 0.76% w/w Sodium Monofluorophosphate and 0.1% w/w Sodium Fluoride and brush their teeth for at least a minute, twice daily (morning and evening) for 12 weeks. |
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Modified Intent-to-Treat (mITT) Population included all randomized participants who completed at least 1 dose of the study product and had at least 1 post-Baseline clinical performance assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Product (Corsodyl Original Toothpaste) | Participants were instructed to dose the toothbrush provided with full ribbon of test product (Corsodyl Original Toothpaste) containing 67% w/w Sodium Bicarbonate and 0.310% w/w Sodium Fluoride and brush their teeth for at least a minute, twice daily (morning and evening) for 12 weeks. |
| BG001 | Reference Product (Colgate Cavity Protection Toothpaste) | Participants were instructed to dose the toothbrush provided with full ribbon of reference product (Colgate Cavity Protection Toothpaste) containing 0.76% w/w Sodium Monofluorophosphate and 0.1% w/w Sodium Fluoride and brush their teeth for at least a minute, twice daily (morning and evening) for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Adjusted Mean Change From Baseline in Number of Bleeding Sites at 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. | mITT Population. Here, overall number analyzed is defined as the number of participants with data available for analysis of this outcome measure. | Posted | Least Squares Mean | Standard Error | bleeding sites | Baseline and Week 12 |
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| Secondary | Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 12 (Test Product Versus [vs.] Reference Product) | 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. | mITT Population. Here, overall number analyzed is defined as the number of participants with data available for analysis of this outcome measure. | Posted | Least Squares Mean | Standard Error | bleeding sites | Baseline and Week 12 |
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| Secondary | Adjusted Mean Change From Baseline in Number of Bleeding Sites at 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. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Least Squares Mean | Standard Error | bleeding sites | Baseline, Week 3, and Week 6 |
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| Secondary | Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 3 and Week 6 (Test Product vs. Reference Product) | 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. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Least Squares Mean | Standard Error | bleeding sites | Baseline, Week 3, and Week 6 |
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| Secondary | Adjusted Mean Change From Baseline in Mean BI at 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. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 3, 6 and 12 |
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| Secondary | Adjusted Mean Change From Baseline in Mean BI at Weeks 3, 6 and 12 (Test Product vs. Reference Product) | 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. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 3, 6 and 12 |
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| Secondary | Adjusted Mean Change From Baseline in Mean Mean Modified Gingival Index (MGI) at 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. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 3, 6 and 12 |
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| Secondary | Adjusted Mean Change From Baseline in Mean MGI at Weeks 3, 6 and 12 (Test Product vs. Reference Product) | 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. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 3, 6 and 12 |
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| Secondary | Adjusted Mean Change From Baseline in Mean Overall TPI (Turesky Plaque Index) at 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). | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 3, 6 and 12 |
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| Secondary | Adjusted Mean Change From Baseline in Mean Overall TPI at Weeks 3, 6 and 12 (Test Product vs. Reference Product) | 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). | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 3, 6 and 12 |
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| Secondary | Adjusted Mean Change From Baseline in Mean Interproximal TPI at 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, mesial sites), and 3 scores were recorded lingually (distal, 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 interproximal TPI score=Average of TPI values over distal and mesial tooth sites assessed for a participant. Lower score indicated 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). | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 3, 6 and 12 |
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| Secondary | Adjusted Mean Change From Baseline in Mean Interproximal TPI at Weeks 3, 6 and 12 (Test Product vs. Reference Product) | 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, mesial sites), and 3 scores were recorded lingually (distal, 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 interproximal TPI score=Average of TPI values over distal and mesial tooth sites assessed for a participant. Lower score indicated 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). | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 3, 6 and 12 |
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From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 111 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of one of the study products including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Product (Corsodyl Original Toothpaste) | Participants were instructed to dose the toothbrush provided with full ribbon of test product (Corsodyl Original Toothpaste) containing 67% w/w Sodium Bicarbonate and 0.310% w/w Sodium Fluoride and brush their teeth for at least a minute, twice daily (morning and evening) for 12 weeks. | 0 | 94 | 0 | 94 | 2 | 94 |
| EG001 | Reference Product (Colgate Cavity Protection Toothpaste) | Participants were instructed to dose the toothbrush provided with full ribbon of reference product (Colgate Cavity Protection Toothpaste) containing 0.76% w/w Sodium Monofluorophosphate and 0.1% w/w Sodium Fluoride and brush their teeth for at least a minute, twice daily (morning and evening) for 12 weeks. | 0 | 96 | 0 | 96 | 4 | 96 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GINGIVAL BLEEDING | Gastrointestinal disorders | Systematic Assessment |
| ||
| TOOTHACHE | Gastrointestinal disorders | Systematic Assessment |
| ||
| VOMITING | Gastrointestinal disorders | Systematic Assessment |
| ||
| GINGIVAL INJURY | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| MIGRAINE | Nervous system disorders | Systematic Assessment |
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HALEON agreements may vary with individual investigators but will not prohibit any investigator from publishing. HALEON supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Haleon Response Center | HALEON | +441932959500 | ww.clinical-trial-register@haleon.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 8, 2023 | Nov 20, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D003773 | Dental Plaque |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian - Central/South Asian Heritage |
|
| Asian - East Asian Heritage |
|
| Asian - South East Asian Heritage |
|
| White - White/Caucasian/European Heritage |
|
| Multiple |
|
| Reference Product (Colgate Cavity Protection Toothpaste) |
Participants were instructed to dose the toothbrush provided with full ribbon of reference product (Colgate Cavity Protection Toothpaste) containing 0.76% w/w Sodium Monofluorophosphate and 0.1% w/w Sodium Fluoride and brush their teeth for at least a minute, twice daily (morning and evening) for 12 weeks. |
|
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|
| Units | Counts |
|---|
| Participants |
|
|
|
Participants were instructed to dose the toothbrush provided with full ribbon of reference product (Colgate Cavity Protection Toothpaste) containing 0.76% w/w Sodium Monofluorophosphate and 0.1% w/w Sodium Fluoride and brush their teeth for at least a minute, twice daily (morning and evening) for 12 weeks. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Reference Product (Colgate Cavity Protection Toothpaste) |
Participants were instructed to dose the toothbrush provided with full ribbon of reference product (Colgate Cavity Protection Toothpaste) containing 0.76% w/w Sodium Monofluorophosphate and 0.1% w/w Sodium Fluoride and brush their teeth for at least a minute, twice daily (morning and evening) for 12 weeks. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| OG001 | Reference Product (Colgate Cavity Protection Toothpaste) | Participants were instructed to dose the toothbrush provided with full ribbon of reference product (Colgate Cavity Protection Toothpaste) containing 0.76% w/w Sodium Monofluorophosphate and 0.1% w/w Sodium Fluoride and brush their teeth for at least a minute, twice daily (morning and evening) for 12 weeks. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Reference Product (Colgate Cavity Protection Toothpaste) |
Participants were instructed to dose the toothbrush provided with full ribbon of reference product (Colgate Cavity Protection Toothpaste) containing 0.76% w/w Sodium Monofluorophosphate and 0.1% w/w Sodium Fluoride and brush their teeth for at least a minute, twice daily (morning and evening) for 12 weeks. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| OG001 |
| Reference Product (Colgate Cavity Protection Toothpaste) |
Participants were instructed to dose the toothbrush provided with full ribbon of reference product (Colgate Cavity Protection Toothpaste) containing 0.76% w/w Sodium Monofluorophosphate and 0.1% w/w Sodium Fluoride and brush their teeth for at least a minute, twice daily (morning and evening) for 12 weeks. |
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