Gingivitis, Plaque
Conditions
Brief summary
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, 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.
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
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Löe and Silness Gingival Index | 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 | 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 |
Countries
Puerto Rico
Contacts
PRINCIPAL_INVESTIGATORAugusto R. Elias-Boneta, DMD.MSD
Dental Research Associates
Outcome results
None listed