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Completed
NCT07224828
The Efficacy of a Battery Toothbrush in the Reduction of Established Plaque and Gingivitis
Conditions: Plaque, Gingivitis
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: Yes
Phase: PHASE3
Enrollment: 130
Sponsor: Colgate Palmolive
Location: Dental Research Associates, Inc. San Juan
Summary
A clinical research study design to compare the effectiveness of a battery toothbrush and dentifrice in reducing gingivitis and dental plaque in adults.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07224828). StuddyBuddy aggregates publicly available trial information.