Overview

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.