PlaquePhase 3NCT07224828
The Efficacy of a Battery Toothbrush in the Reduction of Established Plaque and Gingivitis
A Phase 3 study testing Total Active Prevention Fresh Toothpaste + Colgate Total Active Prevention Battery Toothbrush, Colgate Great Regular + Total Active Prevention Battery Toothbrush and Colgate Great Regular + standard reference flat trim toothpaste in people with Plaque and Gingivitis, run by Colgate Palmolive at 1 site in Puerto Rico.
Trial summary
A clinical research study design to compare the effectiveness of a battery toothbrush and dentifrice in reducing gingivitis and dental plaque in adults. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque, Gingivitis
- What is being tested?
- Total Active Prevention Fresh Toothpaste + Colgate Total Active Prevention Battery Toothbrush, Colgate Great Regular + Total Active Prevention Battery Toothbrush and Colgate Great Regular + standard reference flat trim toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 14 Oct 2025to 28 Jan 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
This is a Phase III, randomized, single-center, parallel group, triple 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
- Plaque, Gingivitis
- Being tested
- Total Active Prevention Fresh Toothpaste + Colgate Total Active Prevention Battery Toothbrush, Colgate Great Regular + Total Active Prevention Battery Toothbrush, Colgate Great Regular + standard reference flat trim toothpaste
- Medical subject headings
- Plaque, Amyloid, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Active Prevention Fresh Toothpaste + Colgate Total Active Prevention Battery ToothbrushDrug
0.454 Stannous Fluoride toothpaste with battery toothbrush
Colgate Great Regular + Total Active Prevention Battery ToothbrushDrug
regular fluoride toothpaste with battery toothbrush
Colgate Great Regular + standard reference flat trim toothpasteDrug
regular fluoride toothpaste with manual toothbrush
| Study group | Role | What they receive |
|---|---|---|
| Test 1 | Experimental | instructed to brush their teeth for two (2) minutes twice a day (morning and evening) with the toothpaste and toothbrush provided. Receives: 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. Receives: 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. Receives: Drug: Colgate Great Regular + standard reference flat trim toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: baseline, 6 week, 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2025
- Study start14 Oct 2025
- Primary completion28 Jan 2026
- Study completion28 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PlaqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Augusto R. Elias-Boneta, DMD.MSD, Principal investigator, Dental Research Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224828
- Sponsor's protocol ID
- CRO-2025-4-PG-BTB-PR-DR
- Status last verified
- Feb 2026
- First submitted
- 4 Nov 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No