Evaluate Inflammation Caused by Gingivitis in Adults

Colgate-Palmolive

Status and phase

Completed

Phase 4

Conditions

Gingivitis

Treatments

Drug: Triclosan/Copolymer/fluoride toothpaste

Drug: sodium monofluorophosphate toothpaste

Study type

Interventional

Funder types

Industry

Identifiers

NCT00941668

CRO-1005-INF-UNC-FP

Details and patient eligibility

About

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

Enrollment

49 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.