Clinical Study to Evaluate Dental Plaque

NCT00758290 | Completed Phase 3 Results

• 1 other identifier: CRO-2008-PLA-13-RR
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gingival Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

A

ACTIVE COMPARATOR

Drug: Triclosan/Fluoride

B

EXPERIMENTAL

Drug: Fluoride/triclosan

Interventions

Triclosan/Fluoride DRUG

Brush twice daily for 3 weeks

A

Fluoride/triclosan DRUG

Brush daily for 3 weeks

B

Eligibility Criteria

• Age: 20 Years - 51 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Bluestone Center for Clinical Research, NYU College of Dentistry

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Gingival Diseases

Interventions

Triclosan; Fluorides

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds

Results Point of Contact

• Title: William DeVizio - DMD
• Organization: Colgate Palmolive

william_devizio@colpal.com

732-878-7901

Study Officials

• Patricia Corby, DDS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 23, 2008
• First Posted: September 25, 2008
• Study Start: May 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: November 25, 2008
• Results First Posted: November 25, 2008

Record last verified: 2008-11

Locations

US (1)