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

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

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

Study Overview

• Status: Completed
• Conditions: Dental Plaque; Dental Gingivitis
• Intervention / Treatment: Drug: China Crest® Pro-health 7 Complete Toothpaste; Drug: China Crest® Cavity Protection Toothpaste

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Oral care regimen	Drug: China Crest® Pro-health 7 Complete Toothpaste; Crest® pro-health manual toothbrush Crest® pro-health gum protection rinse
Placebo Comparator: Control Group; Toothbrush and toothpaste	Drug: China Crest® Cavity Protection Toothpaste; Crest® meliliangje manual toothbrush

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingivitis	Gingivitis was assessed according to the Gingival Bleeding Index	Day 0
Gingivitis	Gingivitis was assessed according to the Gingival Bleeding Index	Day 3
Gingivitis	Gingivitis was assessed according to the Gingival Bleeding Index	Day 10
Gingivitis	Gingivitis was assessed according to the Gingival Bleeding Index	Day 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque Examination	The Modified Turesky Plaque Index was used to examine plaque.	Day 0
Plaque Examination	The Modified Turesky Plaque Index was used to examine plaque.	Day 3
Plaque Examination	The Modified Turesky Plaque Index was used to examine plaque.	Day 10
Plaque Examination	The Modified Turesky Plaque Index was used to examine plaque.	Day 24

Collaborators and Investigators

• Sponsor: Procter and Gamble
• Investigators: Principal Investigator: Tao He, DDS, PhD, Procter and Gamble

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: March 24, 2015
• First Submitted That Met QC Criteria: March 24, 2015
• First Posted (Estimate): March 27, 2015

Study Record Updates

• Last Update Posted (Actual): October 6, 2017
• Last Update Submitted That Met QC Criteria: October 4, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Tooth Diseases; Dental Deposits; Gingivitis; Dental Plaque
• Other Study ID Numbers: 2012135

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No