Evaluate Clinical Research From Commerical Oral Care Products

Phase 3

Completed

• Conditions: Gingival Diseases
• Interventions: Drug: Fluoride; Drug: Triclosan/Fluoride; Drug: Chlorhexidine Gluconate

• Registration Number: NCT00759187
• Lead Sponsor: Colgate Palmolive

Brief Summary

The purpose of this study is to conduct a clinical study comparing anti-plaque efficacy of commercial oral care products.

Detailed Description

The purpose of this study is to compare efficacy of two commercially available toothpastes and one oral rinse on dental plaque control.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Study First Submitted: 2008-09-23
• Study First Submitted QC: 2008-09-23
• Study First Posted: 2008-09-25
• Results First Submitted: 2008-10-16
• Status Verified: 2008-11
• Results First Submitted QC: 2008-11-11
• Results First Posted: 2008-11-18
• Last Update Submitted: 2010-02-24
• Last Update Posted: 2010-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Male or female volunteers 18-65 years of age
• Good general health
• Must sign informed consent form
• Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
• No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.

Exclusion Criteria

• Subjects unable or unwilling to sign the informed consent form.
• Medical condition which requires pre-medication prior to dental visits/procedures
• Moderate or advanced periodontal disease or heavy dental tartar (calculus) requiring more than one visit of cleaning sessions
• 2 or more decayed untreated dental sites at screening.
• Other disease of the hard or soft oral tissues.
• Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
• Use of medications that can currently affect salivary flow.
• Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
• Pregnant or nursing women.
• Participation in any other clinical study within 1 week prior to enrollment into this study.
• Allergy to chlorhexidine
• Use of tobacco products
• Subjects who must receive dental treatment during the study dates.
• Current use of Antibiotics for any purpose.
• Presence of an orthodontic appliance.
• History of allergy to common dentifrice ingredients.
• Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Fluoride	-
B	Triclosan/Fluoride	-
C	Chlorhexidine Gluconate	-

Primary Outcome Measures

Name	Time	Method
Dental Plaque Index	4-Day	Scale 0 to 5 (zero= no plaque to 5 = plaque covering 2/3 or more of the crown of the tooth)

Trial Locations

Locations (1)

Boston University School of Dental Medicine; 🇺🇸 Boston, Massachusetts, United States