The effect of an oral hygiene regimen on periodontal health

Completed

• Conditions: Oral concomitant periodontitis; Oral Health; Chronic periodontitis

• Registration Number: ISRCTN66780304
• Lead Sponsor: Procter & Gamble

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-02-11
• Study Start: 2018-05-11
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 110

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified