A Study to Assess Clinical Gingivitis and Microbiome Following the Use of Multiple Oral Hygiene Products

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study assessed the efficacy of an oral hygiene regimen relative to a standard marketed toothpaste and manual toothbrush.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Procter and Gamble

Criteria

Inclusion Criteria:

• give written informed consent prior to their participation;

• be 18 to 65 years of age at the time of enrollment;

• agree not to participate in any other oral/dental product studies;

• agree to delay any elective dentistry (including a dental prophylaxis);

• agree to refrain from the use of any non-study oral care products (including floss and mouthrinse) during the course of the study;

• agree to return for the scheduled visits and follow study procedures;

• be in good general health as determined by the investigator/designee based on a review of the health history/update for participation in the study;

• have more than 10 bleeding sites at visits 1-3

• Consistency of bleeding site number at baseline may be considered;

• have a minimum of 18 natural teeth with facial and lingual scorable surfaces; and

• refrain from performing any oral hygiene or consuming anything by mouth (except a small amount of water) at least 4 hours prior to their appointment.

Exclusion Criteria:

• teeth that are grossly carious, fully crowned, extensively restored and have heavy dental calculus

• antibiotic, anti-inflammatory or anti-coagulant therapy within two weeks of to the baseline exam

• medical conditions that the investigator considers significant and that may compromise the evaluation of study results

• currently participating in any other clinical trial

• participated in a clinical trial for plaque/gingivitis within the previous 30 days

• pregnant or lactating

• orthodontic appliances or removable partial dentures

• soft or hard tissue tumor of the oral cavity

• advanced periodontal disease

• history of hepatitis, diabetes, or other communicable diseases

• history of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures

• history of significant adverse effects following the use of oral hygiene products such as toothpaste

• oral pathoses that could interfere with compliance and/or examinations or that need treatment.