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

Procter and Gamble0 sites106 target enrollmentApril 2013

Overview

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

Registry

clinicaltrials.gov

Start Date

April 2013

End Date

April 2013

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Procter and Gamble

Responsible Party

Sponsor

•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

•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