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

NCT07224828 | Completed Phase 3 FDA Drug

• 1 other identifier: CRO-2025-4-PG-BTB-PR-DR
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Plaque; Gingivitis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Test 1

EXPERIMENTAL

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

Test 2

ACTIVE COMPARATOR

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

Test 3

ACTIVE COMPARATOR

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

Interventions

Total Active Prevention Fresh Toothpaste + Colgate Total Active Prevention Battery Toothbrush DRUG

0.454 Stannous Fluoride toothpaste with battery toothbrush

Test 1

Colgate Great Regular + Total Active Prevention Battery Toothbrush DRUG

regular fluoride toothpaste with battery toothbrush

Test 2

Colgate Great Regular + standard reference flat trim toothpaste DRUG

regular fluoride toothpaste with manual toothbrush

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:

• 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

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.
• 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.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Dental Research Associates, Inc.

San Juan, 00927, Puerto Rico

Location

MeSH Terms

Conditions

Plaque, Amyloid; Gingivitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Augusto R. Elias-Boneta, DMD.MSD

  Dental Research Associates

  PRINCIPAL INVESTIGATOR

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: November 4, 2025
• First Posted: November 5, 2025
• Study Start: October 14, 2025
• Primary Completion: January 28, 2026
• Study Completion: January 28, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

PR (1)