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CompletedNCT07224828Updated Sep 21, 2026

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

A Phase 3 interventional study of Total Active Prevention Fresh Toothpaste + Colgate Total Active Prevention Battery Toothbrush and Colgate Great Regular + Total Active Prevention Battery Toothbrush in Plaque and Gingivitis, sponsored by Colgate Palmolive. Completed at 1 site in Puerto Rico. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Colgate Palmolive · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Plaque
  • Gingivitis
03

In context

Plaque, Amyloid

89 studies on the registry are indexed under Plaque, Amyloid; 37 are open to participants now.

This study's enrollment of 130 is above the median of 110 across 63 interventional studies indexed under Plaque, Amyloid.

Browse Plaque, Amyloid studies →

Lead sponsor

Colgate Palmolive is the lead sponsor of 114 studies on the registry; 12 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 2 (6%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
130 participants (actual)

Study arms

  • Experimental
    Test 1

    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

  • Active comparator
    Test 2

    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

  • Active comparator
    Test 3

    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

  • DrugTotal Active Prevention Fresh Toothpaste + Colgate Total Active Prevention Battery Toothbrush

    0.454 Stannous Fluoride toothpaste with battery toothbrush

  • DrugColgate Great Regular + Total Active Prevention Battery Toothbrush

    regular fluoride toothpaste with battery toothbrush

  • DrugColgate Great Regular + standard reference flat trim toothpaste

    regular fluoride toothpaste with manual toothbrush

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline,6 week, 12 week

  2. 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

    Time frame: baseline, 6 week, 12 week

07

Study locations

1 site
  • Dental Research Associates, Inc.
    San Juan, 00927, Puerto Rico
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07224828
Lead sponsor
Colgate Palmolive
Responsible party
Sponsor
First posted
Nov 5, 2025
Start date
Oct 14, 2025
Primary completion
Jan 28, 2026
Completion
Jan 28, 2026
Last update
Sep 21, 2026

Study contacts

Augusto R. Elias-Boneta, DMD.MSD
principal investigator · Dental Research Associates

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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