Compare Anti-inflammatory Dentifrices

NCT ID: NCT00762528

Last Updated: 2015-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2010-02-28

Brief Summary

Plaque induced gingivitis

Conditions

Gingivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Total Toothpaste

Triclosan/Copolymer/fluoride toothpaste

Group Type: ACTIVE_COMPARATOR

Triclosan/Copolymer/fluoride toothpaste

Intervention Type: DRUG

Twice daily usage

Fluoride toothpaste

sodium monofluorophosphate toothpaste

Group Type: PLACEBO_COMPARATOR

Sodium monofluorophosphate toothpaste

Intervention Type: DRUG

Twice daily usage

Interventions

Triclosan/Copolymer/fluoride toothpaste

Twice daily usage

Intervention Type: DRUG

Sodium monofluorophosphate toothpaste

Twice daily usage

Intervention Type: DRUG

Other Intervention Names

Toothpaste includes triclosan/fluoride/co-polymer (Total); fluoride only toothpaste

Eligibility Criteria

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 read, understood and signed an informed consent form
• 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 mm and at least 30% of sites bleeding to gentle probing

Exclusion Criteria

• Subjects who have chronically used (i.e., 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 mm 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 or lactating, or female subjects who are of childbearing potential and who report not using hormonal or barrier methods of birth control (oral or parenteral contraceptives, diaphragm plus spermicide, condoms)
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sara G Grossi, DDS

Role: PRINCIPAL_INVESTIGATOR

Locations

East Carolina University, Brody School of Medicine

Greenville, North Carolina, United States

Countries

United States

Other Identifiers

CRO-1107-INF-ECU-FP

Identifier Type: -

Identifier Source: org_study_id