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

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.

This is a Phase III, randomized, single-center, parallel group, double 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.

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.