Plaque
Conditions
Keywords
gingivitis
Brief summary
To evaluate the efficacy of a stannous fluoride toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in Reducing Established Dental Plaque and Gingivitis.
Interventions
DRUG0.454%Stannous fluoride toothpaste
toothpaste
DRUG0.075% Cetylpyridinium Chloride (CPC) and 0.28% zinc lactatmouthwashe
mouthwash
toothpaste
DRUG0.022% Sodium Fluoride mouthwash
mouthwash
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
* Signed Informed Consent Form. * Male and female subjects aged 18-70 years, inclusive. * Availability for the twelve-week duration of the clinical research study. * Good general health based on the opinion of the study investigator * 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.
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; 4. 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 the 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; * An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours; * Current smokers and/or a history of alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Loe-Silness Gingival Index | Baseline, 6-weeks, and 12-weeks | score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces |
| Rustogi Modification of the Navy Plaque Index | Baseline, 6-weeks, and 12-weeks | a red disclosing solution will be used to make plaque visible and improve scoring accuracy. Subjects will be instructed to swish approximately 10 drops of the solution in their mouth for 10-15 seconds before expectorating. |
Countries
United States
Contacts
CONTACTDr. John Gallob, DMD
Outcome results
None listed