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

Not Applicable

Completed

• Conditions: Dental Gingivitis; Dental Plaque
• Interventions: Drug: China Crest® Cavity Protection Toothpaste; Drug: China Crest® Pro-health 7 Complete Toothpaste

• Registration Number: NCT02401360
• Lead Sponsor: Procter and Gamble

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Study First Submitted: 2015-03-24
• Study First Submitted QC: 2015-03-24
• Study First Posted: 2015-03-27
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-04
• Last Update Posted: 2017-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	China Crest® Cavity Protection Toothpaste	Toothbrush and toothpaste
Experimental Group	China Crest® Pro-health 7 Complete Toothpaste	Oral care regimen

Primary Outcome Measures

Name	Time	Method
Gingivitis	Day 24	Gingivitis was assessed according to the Gingival Bleeding Index

Secondary Outcome Measures

Name	Time	Method
Plaque Examination	Day 24	The Modified Turesky Plaque Index was used to examine plaque.