Evaluate Inflammation Caused by Gingivitis in Adults

NCT00941668 | Completed Phase 4 Results

• 1 other identifier: CRO-1005-INF-UNC-FP
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the anti-inflammatory efficacy of a dentifrice

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (2)

• Level of Gingival Crevicular Fluid Interleukin - 1 (GCF IL-1) at 2 Hours

  Levels of Gingival crevicular fluid Interleukin - 1 (GCF IL-1)(weight in micrograms)

  4 weeks

• Level of Gingival Crevicular Fluid Interleukin - 6(GCF IL-6) at 2 Hours

  Levels of Gingival crevicular fluid Interleukin - 6 (GCF IL-6) (weight in micrograms)

  4 weeks

Study Arms (2)

Total Toothpaste

ACTIVE COMPARATOR

Triclosan/Copolymer/fluoride toothpaste

Drug: Triclosan/Copolymer/fluoride toothpaste

Fluoride toothpaste

PLACEBO COMPARATOR

sodium monofluorophosphate toothpaste

Drug: sodium monofluorophosphate toothpaste

Interventions

Triclosan/Copolymer/fluoride toothpaste DRUG

Twice daily usage

Also known as: Total toothpaste

Total Toothpaste

sodium monofluorophosphate toothpaste DRUG

Twice daily usage

Also known as: Colgate cavity protection toothpaste

Fluoride toothpaste

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must be adult males or females 18 to 60 years old
• Subjects must be able and willing to follow study procedures and instructions
• Subjects must have generalized, moderate plaque-associated gingivitis as determined by the Investigator or designee during the screening examination
• Subjects must present with at least 20 teeth in the functional dentition, excluding third molars
• Each subject must have at least four teeth with probing depths of 4-5 millimeters and at least 30% of sites bleeding to gentle probing

You may not qualify if:

• Subjects who have chronically used (two weeks or more) Total (Triclosan/Copolymer) dentifrice within 6 months prior to enrollment
• Subjects with gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque and calculus, or soft or hard tissue tumor of the oral cavity
• Subjects with periodontitis as indicated by periodontal pocketing 6 millimeters at screening
• Subjects with a history of early onset periodontitis or acute necrotizing ulcerative gingivitis
• Subjects with concomitant endodontic or periodontal therapy other than prophylaxis within 6 months prior to enrollment
• Subjects with orthodontic appliances or removable partial dentures
• Subjects chronically treated (two weeks or more) with any medication known to affect inflammation or periodontal status or (aspirin, nonsteroidal anti-inflammatory drugs, steroids, statins, phenytoin, calcium antagonists, cyclosporin and coumadin) within one month of the screening examination. All other medications for chronic medical conditions should be initiated at least three months prior to enrollment
• Subjects who currently smoke or who report using tobacco products within one year of screening.
• Subjects who have been treated with antibiotics for medical or dental reasons within 3 months prior to enrollment
• Subjects having clinically significant or unstable organic disease; subjects having compromised healing potential such as those with diabetes mellitus or connective tissue disorders; subjects having heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement necessitating antibiotic prophylaxis
• Female subjects who report being pregnant
• Subjects who use hormonal contraceptives must have started the method 30 days prior to the screening examination.
• Subjects with active infectious diseases such as hepatitis, human immunodeficiency virus or Tuberculosis
• Subjects diagnosed with human immunodeficiency virus (HIV) or subjects that are immunocompromised as determined by the Investigator
• Medical condition which precludes not eating/drinking for approximately 8 hours.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Triclosan; hydrated silica gel-based toothpaste

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

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

William_DeVizio@colpal.com

732-878-7901

Study Officials

• David Paquette, DMD

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: July 17, 2009
• Study Start: January 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: August 27, 2015
• Results First Posted: July 17, 2009

Record last verified: 2015-08

Locations

US (1)