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Effect of a Commercial Cosmetic Mouth Rinse on Plaque Re-growth

NCT ID: NCT01122862

Last Updated: 2013-09-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-05-31

Brief Summary

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A clinical study to evaluate the effect of a commercial mouth rinse on plaque re-growth

Detailed Description

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Conditions

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Healthy Subjects

Keywords

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tooth plaque

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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0.12% Chlorhexidine Mouthrinse

Commercially available 0.12% Chlorhexidine mouthrinse

Group Type ACTIVE_COMPARATOR

0.12% chlorhexidine mouthrinse

Intervention Type DRUG

commercially available 0.12% chlorhexidine mouthrinse

Cosmetic mouthrinse

Commercially available cosmetic mouthrinse

Group Type ACTIVE_COMPARATOR

Cosmetic mouthrinse

Intervention Type OTHER

Commerically available cosmetic mouthrinse

Sterile Water

Sterile Water

Group Type PLACEBO_COMPARATOR

Sterile water

Intervention Type OTHER

Sterile water

Interventions

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0.12% chlorhexidine mouthrinse

commercially available 0.12% chlorhexidine mouthrinse

Intervention Type DRUG

Cosmetic mouthrinse

Commerically available cosmetic mouthrinse

Intervention Type OTHER

Sterile water

Sterile water

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Good general and oral health
* At least 20 natural gradable teeth
* Mean plaque score (Turesky Modification of the Quigley Hein Index) of greater than or equal to 2.00 at the first baseline visit
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Fort Wayne, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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Z36420889

Identifier Type: -

Identifier Source: org_study_id