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

Colgate-Palmolive

Status and phase: Completed; Phase 3

Conditions: Plaque; Gingivitis

Treatments: Drug: Colgate Great Regular + standard reference flat trim toothpaste; Drug: Colgate Great Regular + Total Active Prevention Battery Toothbrush; Drug: Total Active Prevention Fresh Toothpaste + Colgate Total Active Prevention Battery Toothbrush

Study type: Interventional

Funder types: Industry

Identifiers

NCT07224828

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

Details and patient eligibility

About

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

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

130 participants in 3 patient groups

Test 1

Experimental group

Description:

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

Treatment:

Drug: Total Active Prevention Fresh Toothpaste + Colgate Total Active Prevention Battery Toothbrush

Test 2

Active Comparator group

Description:

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

Treatment:

Drug: Colgate Great Regular + Total Active Prevention Battery Toothbrush

Test 3

Active Comparator group

Description:

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

Treatment:

Drug: Colgate Great Regular + standard reference flat trim toothpaste