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Efficacy of a Stannous Fluoride Toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in Reducing Established Dental Plaque and Gingivitis.

NCT07398846 — Phase 3, Completed, 134 participants, Colgate Palmolive

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A 12-Week Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in Reducing Established Dental Plaque and Gingivitis.

RegistryNCT07398846
StatusCompleted
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment134 (Actual)
SponsorColgate Palmolive (Industry)
ConditionsPlaque
Interventions0.454%Stannous fluoride toothpaste, 0.075% Cetylpyridinium Chloride (CPC) and 0.28% zinc lactatmouthwashe, 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste, 0.022% Sodium Fluoride mouthwash (Drug)
Datesstart 2026-01-26, primary completion 2026-04-29, completion 2026-04-29, first posted 2026-02-10, last updated 2026-05-22
Locations1 site in United States

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All trials for Plaque All trials of 0.454%Stannous fluoride toothpaste All trials of 0.075% Cetylpyridinium Chloride (CPC) and 0.28% zinc lactatmouthwashe

-Summary

To evaluate the efficacy of a stannous fluoride toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in Reducing Established Dental Plaque and Gingivitis.

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+Arms and interventions

ArmTypeInterventionsDescription
Test 1ExperimentalDrug: 0.454%Stannous fluoride toothpaste; Drug: 0.075% Cetylpyridinium Chloride (CPC) and 0.28% zinc lactatmouthwasheinstructed to brush w/ full ribbon, 2x day / 2mins with toothpaste and battery toothbrush provided instructed to 2x day / Swish 20mL for 30 secs with mouthwash provided
Test 2ExperimentalDrug: 0.454%Stannous fluoride toothpaste; Drug: 0.022% Sodium Fluoride mouthwashinstructed to brush w/ full ribbon, 2x day / 2mins with toothpaste and battery toothbrush provided instructed to 2x day / Swish 10mL for 1min with mouthwash provided
Test 3Active comparatorDrug: 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste; Drug: 0.022% Sodium Fluoride mouthwashinstructed to brush w/ full ribbon, 2x day / 2mins with toothpaste and manual toothbrush provided instructed to 2x day / Swish 10mL for 1min with mouthwash provided
  • 0.454%Stannous fluoride toothpaste (Drug): toothpaste
  • 0.075% Cetylpyridinium Chloride (CPC) and 0.28% zinc lactatmouthwashe (Drug): mouthwash
  • 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste (Drug): toothpaste
  • 0.022% Sodium Fluoride mouthwash (Drug): mouthwash

+Outcome measures

Primary outcomes

  • Loe-Silness Gingival Index [Baseline, 6-weeks, and 12-weeks]: score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces
  • Rustogi Modification of the Navy Plaque Index [Baseline, 6-weeks, and 12-weeks]: a red disclosing solution will be used to make plaque visible and improve scoring accuracy. Subjects will be instructed to swish approximately 10 drops of the solution in their mouth for 10-15 seconds before expectorating.

+Eligibility

Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers

Inclusion Criteria:

* Signed Informed Consent Form.
* Male and female subjects aged 18-70 years, inclusive.
* Availability for the twelve-week duration of the clinical research study.
* Good general health based on the opinion of the study investigator
* Minimum of 20 permanent natural teeth (excluding third molars).
* Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
* Initial mean plaque index of at least 0.6 as determined by Rustogi Modification of the Navy plaque index.

Exclusion Criteria:

* Presence of orthodontic appliances;
* Presence of partial removable dentures;
* Oral pathology, chronic disease or tumor(s) of the soft or hard tissues of the oral cavity; 4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone);
* Five or more carious lesions requiring immediate restorative treatment;
* Use of anticonvulsants, sedatives, tranquilizers, anti-inflammatory or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study;
* Use of antibiotics any time during the one-month period prior to entry into the study;
* Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine) and/or on any prescription medicines that might interfere with the study outcome;
* Participation in any other clinical study;
* Self-reported pregnancy and/or breastfeeding;
* Dental prophylaxis within the past three weeks prior to baseline examinations;
* Current allergies and/or history of allergic reactions to oral care products, personal care consumer products, or any of their ingredients;
* An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours;
* Current smokers and/or a history of alcohol or drug abuse

+Locations (1)

FacilityCityCountryStatus
Consumer Research Consulting, LLCMelbourne, FloridaUnited States

My Notes