To Investigate the Clinical Efficacy of an Experimental Toothpaste

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

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-09

Study Completion Date

2009-12-10

Brief Summary

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The objective of this study is to evaluate the effect of an experimental toothpaste on maintaining gingival health over a 24 week period measured through modified gingival index, bleeding, plaque, and plaque bacteria. Prior to commencing study treatment, subjects will undergo a dental prophylaxis followed by a 2 week period of oral hygiene instruction and weekly professional tooth cleaning to bring the subjects to their optimum gingival health prior to commencing study treatment.

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Detailed Description

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Conditions

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Gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental toothpaste

0.1% isopropylmethylphenol and 1150ppm fluoride

Group Type EXPERIMENTAL

isopropylmethylphenol and Fluoride

Intervention Type DRUG

0.1% isopropylmethylphenol and 1150ppm fluoride

Marketed toothpaste

NaF/Silica toothpaste containing 1150ppm fluoride

Group Type OTHER

Fluoride and Silica

Intervention Type DRUG

NaF/Silica toothpaste containing 1150ppm fluoride

Interventions

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isopropylmethylphenol and Fluoride

0.1% isopropylmethylphenol and 1150ppm fluoride

Intervention Type DRUG

Fluoride and Silica

NaF/Silica toothpaste containing 1150ppm fluoride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects aged 18 years and older
* A minimum of 20 permanent gradable teeth
* For baseline eligibility, subjects must have a minimum Modified Gingival Index score of 1.5-2.3.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes