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

Procter & Gamble (P&G)

Status

Completed

Conditions

Dental Plaque

Dental Gingivitis

Treatments

Drug: China Crest® Pro-health 7 Complete Toothpaste

Drug: China Crest® Cavity Protection Toothpaste

Study type

Interventional

Funder types

Industry

Identifiers

2012135

Details and patient eligibility

About

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

Enrollment

106 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.