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

NCT ID: NCT07224828

Last Updated: 2025-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-14

Study Completion Date

2026-01-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Plaque Gingivitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Test 3

instructed to brush their teeth for two (2) minutes twice a day (morning and evening) with the toothpaste and toothbrush provided.

Group Type ACTIVE_COMPARATOR

Colgate Great Regular

Intervention Type DRUG

Colgate Cavity Protection Standard reference Flat Trim toothbrush

Test 1

instructed to brush their teeth for two (2) minutes twice a day (morning and evening) with the toothpaste and toothbrush provided.

Group Type EXPERIMENTAL

Total Active Prevention Fresh Toothpaste Colgate Total Active Prevention Battery Toothbrush

Intervention Type DRUG

0.454 Stannous Fluoride Toothpaste

Test 2

instructed to brush their teeth for two (2) minutes twice a day (morning and evening) with the toothpaste and toothbrush provided.

Group Type ACTIVE_COMPARATOR

Colgate Great Regular

Intervention Type DRUG

Colgate Cavity Protection Colgate Total Active Prevention Battery Toothbrush

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Total Active Prevention Fresh Toothpaste Colgate Total Active Prevention Battery Toothbrush

0.454 Stannous Fluoride Toothpaste

Intervention Type DRUG

Colgate Great Regular

Colgate Cavity Protection Colgate Total Active Prevention Battery Toothbrush

Intervention Type DRUG

Colgate Great Regular

Colgate Cavity Protection Standard reference Flat Trim toothbrush

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Colgate Palmolive

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Augusto R. Elias-Boneta, DMD.MSD

Role: PRINCIPAL_INVESTIGATOR

Dental Research Associates

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dental Research Associates, Inc.

San Juan, , Puerto Rico

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Puerto Rico

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Augusto R. Elias-Boneta, DMD, MSD

Role: CONTACT

(787) 554-0559

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Augusto R Elias-Boneta, DMD, MSD

Role: primary

787-554-0559

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CRO-2025-4-PG-BTB-PR-DR

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Compare Anti-inflammatory Dentifrices
NCT00762528 COMPLETED PHASE4