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Clinical Study Comparing Dental Plaque and Gingivitis Reduction After Using One of Three Oral Hygiene Multi-component Regimens (Using of a Manual Toothbrush, a Toothpaste and a Mouthwash)

NCT02366689 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2016-03-30

Study results available
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Summary

The objective of this clinical research study is to assess the efficacy of a commercially available triclosan/copolymer toothpaste compared to a commercially available oral hygiene multi-component regimen encompassing the use of a manual toothbrush, a toothpaste containing stannous fluoride / sodium hexametaphosphate and a mouthwash containing cetylpyridinium chloride relative to a negative control regimen in reducing established dental plaque and gingivitis over three and six months of assigned product use.

Conditions

  • Dental Plaque
  • Gingivitis

Interventions

DRUG

Triclosan/fluoride toothpaste

Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration).

DRUG

stannous fluoride toothpaste

Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).

DRUG

fluoride only toothpaste

Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.

DRUG

Cetylpyridinium chloride mouthwash

Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds.

DRUG

Fluoride only mouthwash

Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds.

Sponsors & Collaborators

  • Colgate Palmolive

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02366689 on ClinicalTrials.gov