Oral concomitant periodontitis Oral Health Chronic periodontitis
Conditions
Interventions
Participants are stratified based on Screening mean Probing Pocket Depth, mean Gingival Bleeding Index, mean age, gender and tobacco use. Within strata, participants are randomly assigned equally to e
Sponsors
Procter & Gamble
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Give written informed consent and receive a copy of their consent 2. Be between the ages of 18 and 65 3. Be in good general health as determined by the Investigator/designee based on a review of the medical history/update for participation in the study 4. Possess a minimum of 16 natural teeth (excluding third molars) with facial and lingual scorable surfaces 5. Have at least 20 bleeding sites (sum of sites with a score of 1 or 2 on the GBI index) 6. Have at least: 3 eligible healthy sites (PPD <3 mm, no bleeding), 3 eligible gingivitis sites (PPD < 3 mm, bleeding), and 3 eligible periodontal sites (PPD 3-6 mm, bleeding) 7. Agree to delay any elective dentistry until study completion, including additional dental prophylaxes outside the study protocol 8. Agree to refrain from using any non-study oral hygiene products for the study duration (subject will be allowed to continue using floss but they will be instructed not to add/change any other oral hygiene products, including whitening products etc) 9. Agree not to participate in any other oral care clinical study for the duration of this study 10. Agree to return for their scheduled visits and follow study procedures
Exclusion criteria
Exclusion criteria: 1. Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession 2. Active treatment for periodontitis 3. Having a medical condition requiring antibiotic pre-medication prior to dental procedures 4. Fixed facial or lingual orthodontic appliances or removable partial dentures 5. Antibiotic or chlorhexidine use or anti-inflammatory medications within two weeks prior to Screening visit 6. Self-report nursing, pregnancy, or intent to become pregnant during the study 7. Dental prophylaxis within two months prior to the Screening visit 8. Any diseases or conditions that could be expected to interfere with the subject safely completing the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured at baseline, month 6, 12, 18 and 24: 1. Gingival inflammation, measured by Modified Gingival Index 2. Bleeding, measured by Gingival Bleeding Index 3. Periodontal measurements (Gingival Recession and Probing Pocket Depth) | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Israel
Outcome results
None listed