The Efficacy of a Battery Toothbrush in the Reduction of Established Plaque and Gingivitis

Clinical Investigation to Assess the Efficacy of a Battery Toothbrush in the Reduction of Established Plaque and Gingivitis: a 12-week Clinical Study.

A clinical research study design to compare the effectiveness of a battery toothbrush and dentifrice in reducing gingivitis and dental plaque in adults.

Study Overview

• Status: Completed
• Conditions: Gingivitis; Plaque
• Intervention / Treatment: Drug: Total Active Prevention Fresh Toothpaste + Colgate Total Active Prevention Battery Toothbrush; Drug: Colgate Great Regular + Total Active Prevention Battery Toothbrush; Drug: Colgate Great Regular + standard reference flat trim toothpaste

Detailed Description

This is a Phase III, randomized, single-center, parallel group, double blind, clinical research study design to compare the effectiveness of a battery toothbrush and dentifrice in reducing gingivitis and dental plaque in adults. This study will have 3 arms to determine the efficacy of a battery toothbrush vs a positive control regimen and a negative control regimen to reduce plaque and gingivitis.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00927
    • Dental Research Associates, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male and Female, age 18-70, inclusive.
• Availability for the 12-week duration of the clinical research study.
• Good general health at the discretion of the dental examiner or study investigators.
• 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.
• Signed Informed Consent Form

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.
• 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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test 1; instructed to brush their teeth for two (2) minutes twice a day (morning and evening) with the toothpaste and toothbrush provided.	Drug: Total Active Prevention Fresh Toothpaste + Colgate Total Active Prevention Battery Toothbrush; 0.454 Stannous Fluoride toothpaste with battery toothbrush
Active Comparator: Test 2; instructed to brush their teeth for two (2) minutes twice a day (morning and evening) with the toothpaste and toothbrush provided.	Drug: Colgate Great Regular + Total Active Prevention Battery Toothbrush; regular fluoride toothpaste with battery toothbrush
Active Comparator: Test 3; instructed to brush their teeth for two (2) minutes twice a day (morning and evening) with the toothpaste and toothbrush provided.	Drug: Colgate Great Regular + standard reference flat trim toothpaste; regular fluoride toothpaste with manual toothbrush

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Löe and Silness Gingival Index	score from 0 to 3 will be assigned by the examining dentist to all scorable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scorable surface and dividing that number by the total number of surfaces scored.	baseline,6 week, 12 week
Rustogi Mod. Navy Plaque Index	An expanded form of the Rustogi Modified Navy Plaque Index, used to measure plaque on different surfaces of teeth. Plaque disclosing solution used	baseline, 6 week, 12 week

Collaborators and Investigators

• Sponsor: Colgate Palmolive
• Investigators: Principal Investigator: Augusto R. Elias-Boneta, DMD.MSD, Dental Research Associates

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2025
• Primary Completion (Actual): January 28, 2026
• Study Completion (Actual): January 28, 2026

Study Registration Dates

• First Submitted: November 4, 2025
• First Submitted That Met QC Criteria: November 4, 2025
• First Posted (Actual): November 5, 2025

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Infections; Gingival Diseases; Pathological Conditions, Signs and Symptoms; Plaque, Amyloid; Gingivitis
• Other Study ID Numbers: CRO-2025-4-PG-BTB-PR-DR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No