Trial · NCT06660069
A Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste With a Cetylpyridinium Chloride Mouthwash in Improving Gingival Health and Reducing Plaque Accumulation
NCT06660069, Not applicable, Completed, HALEON; results first posted 2026-03-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste With a Cetylpyridinium Chloride Mouthwash in Improving Gingival Health and Reducing Plaque Accumulation. Trials, record NCT06660069. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06660069
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste With a Cetylpyridinium Chloride Mouthwash in Improving Gingival Health and Reducing Plaque Accumulation
- NCT number
- NCT06660069
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 199 participants, actual
- Lead sponsor
- HALEON
- Conditions
- Dental Plaque, Gingivitis
- Interventions
Stannous Fluoride Toothpaste (Parodontax Complete Protection Toothpaste), CPC Mouthwash (Parodontax Active Gum Health Mouthwash), Regular Fluoride Toothpaste (Crest Cavity Protection), Stannous Fluoride Toothpaste (Parodontax Complete Protection Toothpaste)
- First posted
- 2024-10-26
- Last updated
- 2026-03-18
- Results first posted
- 2026-03-18
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Number of Bleeding Sites (NBS) at Week 12 (Toothpaste/Mouthwash Versus [vs.] Negative Control Toothpaste) | Week 12 | Gingival bleeding was assessed according to the expanded bleeding index (EBI), by inserting a periodontal probe into the gingival crevice and sweeping from distal to mesial around the tooth at an approximate angle of 60 degrees, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth were assessed. Presence/absence of gingival bleeding was assessed for 30 seconds after probing. The NBS for each participant was calculated as the number of evaluable tooth sites (having two-thirds of the natural tooth surface gradable for the assessment) with bleeding observed immediately on probing or within 30 seconds of probing. |
| Secondary | Interproximal NBS at Week 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Week 12 | Gingival bleeding was assessed according to the EBI, by inserting a periodontal probe into the gingival crevice and sweeping from distal to mesial around the tooth at an approximate angle of 60 degrees, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth was assessed. Presence/absence of gingival bleeding was assessed for 30 seconds after probing. The NBS for each participant was calculated as the number of evaluable tooth sites (having two-thirds of the natural tooth surface gradable for the assessment) with bleeding observed immediately on probing or within 30 seconds of probing. |
| Secondary | Overall NBS at Week 6 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Week 6 | Gingival bleeding was assessed according to the EBI, by inserting a periodontal probe into the gingival crevice and sweeping from distal to mesial around the tooth at an approximate angle of 60 degrees, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth was assessed. Presence/absence of gingival bleeding was assessed for 30 seconds after probing. The NBS for each participant was calculated as the number of evaluable tooth sites (having two-thirds of the natural tooth surface gradable for the assessment) with bleeding observed immediately on probing or within 30 seconds of probing. |
| Secondary | Interproximal NBS at Week 6 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Week 6 | Gingival bleeding was assessed according to the EBI, by inserting a periodontal probe into the gingival crevice and sweeping from distal to mesial around the tooth at an approximate angle of 60 degrees, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth was assessed. Presence/absence of gingival bleeding was assessed for 30 seconds after probing. The NBS for each participant was calculated as the number of evaluable tooth sites (having two-thirds of the natural tooth surface gradable for the assessment) with bleeding observed immediately on probing or within 30 seconds of probing. |
| Secondary | Mean Overall Bleeding Index (Bl) at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Week 6 and Week 12 | Gingival bleeding was assessed according to the EBI, by inserting a periodontal probe into the gingival crevice and sweeping from distal to mesial around the tooth at an approximate angle of 60 degrees, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth was assessed. Presence/absence of gingival bleeding was assessed for 30 seconds after probing and scored on a 3-points scale ranging from 0 to 2, where 0 equal to (=) 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 improvement in the symptoms. |
| Secondary | Mean Interproximal BI at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Week 6 and Week 12 | Gingival bleeding was assessed according to the EBI, by inserting a periodontal probe into the gingival crevice and sweeping from distal to mesial around the tooth at an approximate angle of 60 degrees, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth was assessed. Presence/absence of gingival bleeding was assessed for 30 seconds after probing and scored on a 3-points 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 improvement in the symptoms. |
| Secondary | Mean Overall Modified Gingival Index (MGI) at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Week 6 and Week 12 | The MGI assessment was a non-invasive evaluation which focused on the visual symptoms of gingivitis (for example, redness, texture, edema). MGI was assessed on the buccal and lingual marginal gingiva and interdental papillae of all scorable teeth (second permanent molar to second permanent molar in each arch) and scored on a 5-point scale ranging from 0 to 4, where 0=Absence of inflammation; 1=Mild inflammation; slight change in colour, little change in colour; little change in texture of any portion of the 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 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 score indicated improvement in the symptoms. |
| Secondary | Mean Interproximal MGI at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Week 6 and Week 12 | The MGI assessment was a non-invasive evaluation which focused on the visual symptoms of gingivitis (for example, redness, texture, edema). MGI was assessed on the buccal and lingual marginal gingiva and interdental papillae of all scorable teeth (second permanent molar to second permanent molar in each arch) and scored on a 5-point scale ranging from 0 to 4, where 0=Absence of inflammation; 1=Mild inflammation; slight change in colour, little change in colour; little change in texture of any portion of the 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 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 score indicated improvement in the symptoms. |
| Secondary | Mean Overall Turesky Plaque Index (TPI) at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Week 6 and Week 12 | The TPI was used to assess plaque on the facial and lingual surfaces of each scorable tooth (second molar to second molar). Three scores were recorded buccally/labially (distal, body, mesial sites) and three scores lingually/ palatally (distal, body, mesial sites) and mean was calculated. The plaque was first be disclosed using a plaque disclosing dye solution and the disclosed plaque was 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. Lower score indicated improvement in the symptoms. |
| Secondary | Mean Interproximal TPI at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Week 6 and Week 12 | The TPI was used to assess plaque on the facial and lingual surfaces of each scorable tooth (second molar to second molar). Three scores were recorded buccally/labially (distal, body, mesial sites) and three scores lingually/palatally (distal, body, mesial sites) and mean was calculated. The plaque was first be disclosed using a plaque disclosing dye solution and the disclosed plaque was 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. Lower score indicated improvement in the symptoms. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Number of Bleeding Sites (NBS) at Week 12 (Toothpaste/Mouthwash Versus [vs.] Negative Control Toothpaste) | Week 12 | The modified Intention-To-Treat (mITT) population comprised of all randomized participants who received at least one dose of investigational product and completed at least one-post Baseline efficacy assessment. Only those participants with data available at the specified timepoint were analyzed. | bleeding sites | LEAST_SQUARES_MEAN |
| SECONDARY | Interproximal NBS at Week 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Week 12 | mITT Population. Only those participants with data available at the specified timepoint were analyzed. | bleeding sites | LEAST_SQUARES_MEAN |
| SECONDARY | Overall NBS at Week 6 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Week 6 | mITT Population. Only those participants with data available at the specified timepoint were analyzed. | bleeding sites | LEAST_SQUARES_MEAN |
| SECONDARY | Interproximal NBS at Week 6 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Week 6 | mITT Population. | bleeding sites | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Overall Bleeding Index (Bl) at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Week 6 and Week 12 | mITT Population. Only those participants with data available at the specified timepoint were analyzed. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Interproximal BI at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Week 6 and Week 12 | mITT Population. Only those participants with data available at the specified timepoint were analyzed. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Overall Modified Gingival Index (MGI) at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Week 6 and Week 12 | mITT Population. Only those participants with data available at the specified timepoint were analyzed. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Interproximal MGI at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Week 6 and Week 12 | mITT Population. Only those participants with data available at the specified timepoint were analyzed. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Overall Turesky Plaque Index (TPI) at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Week 6 and Week 12 | mITT Population. Only those participants with data available at the specified timepoint were analyzed. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Interproximal TPI at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Week 6 and Week 12 | mITT Population. Only those participants with data available at the specified timepoint were analyzed. | score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Number of Bleeding Sites (NBS) at Week 12 (Toothpaste/Mouthwash Versus [vs.] Negative Control Toothpaste) | Toothpaste/Mouthwash (SnF2 Toothpaste Followed by CPC Mouthwash) | 10.1 | Standard Error 1.03 | bleeding sites | |
| Overall Number of Bleeding Sites (NBS) at Week 12 (Toothpaste/Mouthwash Versus [vs.] Negative Control Toothpaste) | Negative Control Toothpaste (Sodium Fluoride Toothpaste) | 24.1 | Standard Error 1.05 | bleeding sites | |
| Interproximal NBS at Week 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Toothpaste/Mouthwash (SnF2 Toothpaste Followed by CPC Mouthwash) | 4.5 | Standard Error 0.72 | bleeding sites | |
| Interproximal NBS at Week 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Negative Control Toothpaste (Sodium Fluoride Toothpaste) | 15.0 | Standard Error 0.74 | bleeding sites | |
| Overall NBS at Week 6 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Toothpaste/Mouthwash (SnF2 Toothpaste Followed by CPC Mouthwash) | 10.6 | Standard Error 1.09 | bleeding sites | |
| Overall NBS at Week 6 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Negative Control Toothpaste (Sodium Fluoride Toothpaste) | 25.0 | Standard Error 1.09 | bleeding sites | |
| Interproximal NBS at Week 6 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Toothpaste/Mouthwash (SnF2 Toothpaste Followed by CPC Mouthwash) | 5.1 | Standard Error 0.76 | bleeding sites | |
| Interproximal NBS at Week 6 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Negative Control Toothpaste (Sodium Fluoride Toothpaste) | 15.4 | Standard Error 0.76 | bleeding sites | |
| Mean Overall Bleeding Index (Bl) at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Toothpaste/Mouthwash (SnF2 Toothpaste Followed by CPC Mouthwash) | Week 6 | 0.08 | Standard Error 0.009 | score on a scale |
| Mean Overall Bleeding Index (Bl) at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Negative Control Toothpaste (Sodium Fluoride Toothpaste) | Week 6 | 0.20 | Standard Error 0.009 | score on a scale |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Toothpaste/Mouthwash (SnF2 Toothpaste Followed by CPC Mouthwash) | 65 | |
| Overall Study | STARTED | Reference Toothpaste (SnF2 Toothpaste) | 65 | |
| Overall Study | STARTED | Negative Control Toothpaste (Sodium Fluoride Toothpaste) | 66 | |
| Overall Study | COMPLETED | Toothpaste/Mouthwash (SnF2 Toothpaste Followed by CPC Mouthwash) | 63 | |
| Overall Study | COMPLETED | Reference Toothpaste (SnF2 Toothpaste) | 61 | |
| Overall Study | COMPLETED | Negative Control Toothpaste (Sodium Fluoride Toothpaste) | 59 | |
| Overall Study | NOT COMPLETED | Toothpaste/Mouthwash (SnF2 Toothpaste Followed by CPC Mouthwash) | 2 | |
| Overall Study | NOT COMPLETED | Reference Toothpaste (SnF2 Toothpaste) | 4 | |
| Overall Study | NOT COMPLETED | Negative Control Toothpaste (Sodium Fluoride Toothpaste) | 7 |
Source ClinicalTrials.gov
Adverse events21
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 | Tooth Discolouration | Gastrointestinal disorders | Toothpaste/Mouthwash (SnF2 Toothpaste Followed by CPC Mouthwash) | 14 | 65 | |
| other | Tooth Discolouration | Gastrointestinal disorders | Reference Toothpaste (SnF2 Toothpaste) | 1 | 65 | |
| other | Tooth Discolouration | Gastrointestinal disorders | Negative Control Toothpaste (Sodium Fluoride Toothpaste) | 0 | 66 | |
| other | Aphthous Ulcer | Gastrointestinal disorders | Toothpaste/Mouthwash (SnF2 Toothpaste Followed by CPC Mouthwash) | 2 | 65 | |
| other | Aphthous Ulcer | Gastrointestinal disorders | Reference Toothpaste (SnF2 Toothpaste) | 2 | 65 | |
| other | Aphthous Ulcer | Gastrointestinal disorders | Negative Control Toothpaste (Sodium Fluoride Toothpaste) | 0 | 66 | |
| other | Oral Mucosal Exfoliation | Gastrointestinal disorders | Toothpaste/Mouthwash (SnF2 Toothpaste Followed by CPC Mouthwash) | 2 | 65 | |
| other | Oral Mucosal Exfoliation | Gastrointestinal disorders | Reference Toothpaste (SnF2 Toothpaste) | 1 | 65 | |
| other | Oral Mucosal Exfoliation | Gastrointestinal disorders | Negative Control Toothpaste (Sodium Fluoride Toothpaste) | 1 | 66 | |
| other | Tongue Coated | Gastrointestinal disorders | Toothpaste/Mouthwash (SnF2 Toothpaste Followed by CPC Mouthwash) | 2 | 65 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Toothpaste/Mouthwash (SnF2 Toothpaste Followed by CPC Mouthwash) | 0 | 65 |
| Total, all-cause mortality | Reference Toothpaste (SnF2 Toothpaste) | 0 | 65 |
| Total, all-cause mortality | Negative Control Toothpaste (Sodium Fluoride Toothpaste) | 0 | 66 |
| Total, other adverse events | Toothpaste/Mouthwash (SnF2 Toothpaste Followed by CPC Mouthwash) | 19 | 65 |
| Total, other adverse events | Reference Toothpaste (SnF2 Toothpaste) | 6 | 65 |
| Total, other adverse events | Negative Control Toothpaste (Sodium Fluoride Toothpaste) | 2 | 66 |
| Total, serious adverse events | Toothpaste/Mouthwash (SnF2 Toothpaste Followed by CPC Mouthwash) | 0 | 65 |
| Total, serious adverse events | Reference Toothpaste (SnF2 Toothpaste) | 0 | 65 |
| Total, serious adverse events | Negative Control Toothpaste (Sodium Fluoride Toothpaste) | 0 | 66 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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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