The Efficacy of a Battery Toothbrush in the Reduction of Established Plaque and Gingivitis
NCT ID: NCT07224828
Last Updated: 2025-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
135 participants
INTERVENTIONAL
2025-10-14
2026-01-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Test 3
instructed to brush their teeth for two (2) minutes twice a day (morning and evening) with the toothpaste and toothbrush provided.
Colgate Great Regular
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.
Total Active Prevention Fresh Toothpaste Colgate Total Active Prevention Battery Toothbrush
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.
Colgate Great Regular
Colgate Cavity Protection Colgate Total Active Prevention Battery Toothbrush
Interventions
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Total Active Prevention Fresh Toothpaste Colgate Total Active Prevention Battery Toothbrush
0.454 Stannous Fluoride Toothpaste
Colgate Great Regular
Colgate Cavity Protection Colgate Total Active Prevention Battery Toothbrush
Colgate Great Regular
Colgate Cavity Protection Standard reference Flat Trim toothbrush
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
70 Years
ALL
Yes
Sponsors
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Colgate Palmolive
INDUSTRY
Responsible Party
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Principal Investigators
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Augusto R. Elias-Boneta, DMD.MSD
Role: PRINCIPAL_INVESTIGATOR
Dental Research Associates
Locations
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Dental Research Associates, Inc.
San Juan, , Puerto Rico
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CRO-2025-4-PG-BTB-PR-DR
Identifier Type: -
Identifier Source: org_study_id
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