Dental plaque and gingivitis Oral Health
Conditions
Sponsors
Procter & Gamble (United States)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Give written informed consent prior to study participation and be given a signed copy of their informed consent form 2. Be at least 18 years of age and mainly use a manual toothbrush 3. Be in good general health as determined by the investigator/designee based on a review/update of their medical history 4. Possess a minimum of 16 natural teeth with facial and lingual scorable surfaces 5. Have localized or generalized gingivitis with a range of 10% to 70% bleeding sites (sites with a score of 1 in the Gingival Health Assessment at Screening) 6. Agree not to participate in any other oral care study for the duration of this study 7. agree to not to have any elective dentistry, including dental prophylaxis, until study completion and to report any non-study dentistry received at any time during the course of this study 8. Agree to refrain from using any non-study oral hygiene products for the study duration 9. Agree to return for all their scheduled visits and to follow all study procedures 10. Refrain from brushing their teeth or from performing any other oral hygiene procedure anytime within the 12 hours prior to the Baseline Visit and agree to follow these same restrictions prior to all visits 11. Refrain from medicated lozenges, breath mints, eating, drinking*, chewing gum and using tobacco (of any kind) for at least 4 hours prior to this visit and agree to follow these same restrictions prior to all visits. *(Allowed small sips of water up until 45 minutes prior to their appointments.)
Exclusion criteria
Exclusion criteria: 1. A condition requiring the need for antibiotic premedication prior to dental procedures 2. Severe periodontal disease, including but not limited to, purulent exudates, generalized mobility, and/or severe recession 3. Self-reported pregnancy or nursing 4. Three or more carious lesions requiring restorative treatment 5. Active treatment for the following conditions: periodontitis, cancer, or a seizure disorder 6. Taking an antibiotic or using a chlorhexidine mouth rinse any time within the previous 2 weeks 7. Have diabetes 8. Taking anti-inflammatory or anti-coagulant medications any time within the previous 2 weeks 9. Have any of the following: orthodontic appliances, removable partial dentures, peri/oral piercings, a pacemaker or other implanted device (overnight removable retainers, bite splints & night guards are allowed) 10. Oral/gum surgery within the previous 2 months 11. A disease or condition that could possibly interfere with examination/procedures or with the subject’s safe completion of this study (including allergies to dye) 12. Having a dental prophylaxis at any time within the previous 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of bleeding sites measured by the Gingival Bleeding Index from baseline to Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Whole mouth plaque measured using the Rustogi Modification of the Navy Plaque Index (RMNPI) from baseline (pre-brushing) at Week 4 2. Whole mouth plaque removal measured using the Rustogi Modification of the Navy Plaque Index (RMNPI) at Baseline (single brushing) 3. Gingivitis measured using the Modified Gingival Index (MGI) from baseline at Week 4 | — |
Countries
United States of America
Contacts
Public ContactMalgorzata Klukowska
Outcome results
None listed