Clinical Study to Evaluate Dental Plaque

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

Study Overview

• Status: Completed
• Conditions: Gingival Diseases
• Intervention / Treatment: Drug: Triclosan/Fluoride; Drug: Fluoride/triclosan

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Bluestone Center for Clinical Research, NYU College of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 51 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: A	Drug: Triclosan/Fluoride; Brush twice daily for 3 weeks
EXPERIMENTAL: B	Drug: Fluoride/triclosan; Brush daily for 3 weeks

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Colgate Palmolive

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (ACTUAL): July 1, 2008
• Study Completion (ACTUAL): July 1, 2008

Study Registration Dates

• First Submitted: September 23, 2008
• First Submitted That Met QC Criteria: September 23, 2008
• First Posted (ESTIMATE): September 25, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): November 25, 2008
• Last Update Submitted That Met QC Criteria: November 20, 2008
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Dental Deposits; Dental Plaque; Gingival Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Antimetabolites; Protective Agents; Hypolipidemic Agents; Lipid Regulating Agents; Cariostatic Agents; Fatty Acid Synthesis Inhibitors; Fluorides; Triclosan
• Other Study ID Numbers: CRO-2008-PLA-13-RR