Clinical Study to Evaluate Dental Plaque

Phase 3

Completed

• Conditions: Gingival Diseases
• Interventions: Drug: Triclosan/Fluoride; Drug: Fluoride/triclosan

• Registration Number: NCT00758290
• Lead Sponsor: Colgate Palmolive

Brief Summary

Clinical research study to determine anti-plaque efficacy of a prototype toothpastes for a 3 week brushing regiment.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2008-07
• Study Completion: 2008-07
• 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: 2008-11-20
• Last Update Submitted: 2008-11-20
• Results First Posted: 2008-11-25
• Last Update Posted: 2008-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Male or female volunteers at least 20 - 51 years of age
• Good general health
• Must sign informed consent form
• Minimum of 15 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)
• 5 or more decayed untreated dental sites at screening (cavities)
• 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 are currently affecting salivary function
• 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
• 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 which interferes with plaque scoring
• History of allergy to common toothpaste ingredients
• History of allergy to arginine (amino acid)
• Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Triclosan/Fluoride	-
B	Fluoride/triclosan	-

Primary Outcome Measures

Name	Time	Method
Dental Plaque Index	4 Day	Plaque units measured on a scale between 0 to 5. No plaque=0;5=2/3 of tooth covered in plaque

Trial Locations

Locations (1)

Bluestone Center for Clinical Research, NYU College of Dentistry; 🇺🇸 New York, New York, United States