MANUAL TOOTHBRUSHES AND REVERSAL OF EXPERIMENTAL GINGIVITIS
- Conditions
- gingivitis
- Registration Number
- NL-OMON28803
- Lead Sponsor
- The Procter & Gamble CompanyRegulatory and Clinical Development8700 Mason-Montgomery RoadMason, OH 45040
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
1. Be between the ages of 18 and 70
2. Be in good general health as determined by the investigator/designee based on a review of the medical history/update
Exclusion Criteria
1. Orthodontic banding or wires or partial dentures
2. Severe periodontal disease (no sites with PPD > 5mm), including but not limited to purulent exudate, generalized mobility, and or severe recession
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bleeding on Marginal Probing (BOMP) – Angular Bleeding Index (Van der Weijden 1994).<br /><br>This score will be done on day 0, day 21, week 1, week 2 en week 4. <br /><br>The gingiva is lightly dried with compressed air and lightly probed with a probe. The probe is inserted into the gingival crevice to a depth of approximately 2mm or until slight resistance is felt. The probe is run gently along the marginal gingival holding the probe at a an angle of approximately 60 degrees to the longitudinal axis of the tooth and in contact with the sulcular epithelium. Minimum axial force is used to avoid undue penetration in the tissue. The probe is moved around the crevice gently stretching the epithelium. A bleeding score is given to six gingival areas of the tooth. These are the disto-vestibular, vestibular, mesio-vestibular, disto-lingual, lingual and the mesio-lingual regions. <br>
- Secondary Outcome Measures
Name Time Method