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

NCT ID: NCT02401360

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-04-30

Brief Summary

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

Detailed Description

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Conditions

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Dental Plaque Dental Gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental Group

Oral care regimen

Group Type EXPERIMENTAL

China Crest® Pro-health 7 Complete Toothpaste

Intervention Type DRUG

Crest® pro-health manual toothbrush Crest® pro-health gum protection rinse

Control Group

Toothbrush and toothpaste

Group Type PLACEBO_COMPARATOR

China Crest® Cavity Protection Toothpaste

Intervention Type DRUG

Crest® meliliangje manual toothbrush

Interventions

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China Crest® Pro-health 7 Complete Toothpaste

Crest® pro-health manual toothbrush Crest® pro-health gum protection rinse

Intervention Type DRUG

China Crest® Cavity Protection Toothpaste

Crest® meliliangje manual toothbrush

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Procter and Gamble

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tao He, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Procter and Gamble

Other Identifiers

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2012135

Identifier Type: -

Identifier Source: org_study_id