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
- Are there results?
- None posted in the registry
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.
Show all 12Show fewer
- 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.
- More trials run by Colgate PalmoliveThe sponsor's other registered studies.
- 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
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07224828
- Acronym / sponsor ID
- CRO-2025-4-PG-BTB-PR-DR
- Conditions
- Plaque, Gingivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 28 Jan 2026 (actual)
- First posted
- 5 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test 1 | Experimental | Drug: Total Active Prevention Fresh Toothpaste + Colgate Total Active Prevention Battery Toothbrushinstructed to brush their teeth for two (2) minutes twice a day (morning and evening) with the toothpaste and toothbrush provided. |
| Test 2 | Active comparator | Drug: Colgate Great Regular + Total Active Prevention Battery Toothbrushinstructed to brush their teeth for two (2) minutes twice a day (morning and evening) with the toothpaste and toothbrush provided. |
| Test 3 | Active comparator | Drug: Colgate Great Regular + standard reference flat trim toothpasteinstructed to brush their teeth for two (2) minutes twice a day (morning and evening) with the toothpaste and toothbrush provided. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Active Prevention Fresh Toothpaste + Colgate Total Active Prevention Battery Toothbrush0.454 Stannous Fluoride toothpaste with battery toothbrush | Drug | Test 1 |
| Colgate Great Regular + Total Active Prevention Battery Toothbrushregular fluoride toothpaste with battery toothbrush | Drug | Test 2 |
| Colgate Great Regular + standard reference flat trim toothpasteregular fluoride toothpaste with manual toothbrush | Drug | Test 3 |
Primary outcome
Löe and Silness Gingival Index
Time frame: baseline,6 week, 12 week
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.
Rustogi Mod. Navy Plaque Index
Time frame: baseline, 6 week, 12 week
An expanded form of the Rustogi Modified Navy Plaque Index, used to measure plaque on different surfaces of teeth. Plaque disclosing solution used
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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Enrolling by invitation
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Microbiome, Cytokines
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Augusto R. Elias-Boneta, DMD.MSD principal investigator
Dental Research Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Löe and Silness Gingival Index (time frame: baseline,6 week, 12 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.