Clinical Study to Evaluate the Treatment of Gingivitis of Two Toothpastes

NCT00762515 | Completed Phase 3 Results

• 1 other identifier: CRO-2007-GIN-03-RR
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to compare two commerical oral products for the treatment of gingivitis.

Conditions

Dental Plaque

Outcome Measures

Primary Outcomes (1)

• Control Established Plaque in Adults

  Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Total Plaque score=sum of all scores divided by the number of sites (teeth) scored.

  6 weeks

Secondary Outcomes (1)

• Control Gingivitis in Adults

  6 weeks

Study Arms (2)

A

PLACEBO COMPARATOR

commercially available Fluoride only toothpaste

Drug: Fluoride

B

ACTIVE COMPARATOR

Commercially available triclosan/copolymer/fluoride toothpaste

Drug: Triclosan; Drug: Fluoride

Interventions

Fluoride DRUG

Brush teeth two times daily for 6 weeks

A

Triclosan DRUG

Brush two times daily for 6 weeks

B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female volunteers 18-65 years of age
• Good general health
• Must sign informed consent form
• Minimum of 16 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.
• Dental Selection Criteria: Gingivitis patients with a minimum of 16 gradable teeth with a minimum of 6 sites with a GI score of ≥ 3. Subjects will be stratified according to gingivitis severity. Average full mouth GI score should be in the range of 2.0 - 2.5. heavy plaque formers should be avoided. Target a full mouth PI (Quigley-Hein) to be in the range of 1.5-3.0

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
• History of allergy to iodine
• History of thyroid disease
• History of diabetes
• 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 are 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.
• Use of tobacco products
• Subjects who must receive dental treatment during the study dates.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

University of Louisville, School of Dentistry

Louisville, Kentucky, 40292, United States

Location

MeSH Terms

Conditions

Dental Plaque

Interventions

Fluorides; Triclosan

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: William Devizio
• Organization: Colgate Palmolive Co.

William_Devizio@colpal.com

732-878-7901

Study Officials

• Denis Kinane, BDS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: February 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: December 28, 2010
• Results First Posted: December 14, 2010

Record last verified: 2010-12

Locations

US (1)