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

NCT07398846 | Completed Phase 3 FDA Drug

• 1 other identifier: CRO-2025-05-PG-BTB-FL-BGS
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Plaque

Keywords

gingivitis

Outcome Measures

Primary Outcomes (2)

• Loe-Silness Gingival Index

  score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces

  Baseline, 6-weeks, and 12-weeks

• Rustogi Modification of the Navy Plaque Index

  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.

  Baseline, 6-weeks, and 12-weeks

Study Arms (3)

Test 1

EXPERIMENTAL

instructed 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

Drug: 0.454%Stannous fluoride toothpaste; Drug: 0.075% Cetylpyridinium Chloride (CPC) and 0.28% zinc lactatmouthwashe

Test 2

EXPERIMENTAL

instructed 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

Drug: 0.454%Stannous fluoride toothpaste; Drug: 0.022% Sodium Fluoride mouthwash

Test 3

ACTIVE COMPARATOR

instructed 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

Drug: 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste; Drug: 0.022% Sodium Fluoride mouthwash

Interventions

0.454%Stannous fluoride toothpaste DRUG

toothpaste

Test 1; Test 2

0.075% Cetylpyridinium Chloride (CPC) and 0.28% zinc lactatmouthwashe DRUG

mouthwash

Test 1

0.76% Sodium Monofluorophosphate (Na MFP) toothpaste DRUG

toothpaste

Test 3

0.022% Sodium Fluoride mouthwash DRUG

mouthwash

Test 2; Test 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Consumer Research Consulting, LLC

Melbourne, Florida, 32935, United States

Location

MeSH Terms

Conditions

Plaque, Amyloid; Gingivitis

Interventions

Cetylpyridinium; cytidylyl-(3'-5')-cytidine; fluorophosphate; Supersmile; Toothpastes

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Pyridinium Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dentifrices; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 10, 2026
• Study Start: January 26, 2026
• Primary Completion: April 29, 2026
• Study Completion: April 29, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

US (1)