Evaluate Inflammation Caused by Gingivitis in Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00941668
First received: September 26, 2008
Last updated: August 18, 2015
Last verified: August 2015
  Purpose
The purpose of this study is to compare the anti-inflammatory efficacy of a dentifrice

Condition Intervention Phase
Gingivitis
Drug: Triclosan/Copolymer/fluoride toothpaste
Drug: sodium monofluorophosphate toothpaste
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluate Inflammation Caused by Gingivitis in Adults

Resource links provided by NLM:


Further study details as provided by Colgate Palmolive:

Primary Outcome Measures:
  • Level of Gingival Crevicular Fluid Interleukin - 1 (GCF IL-1) at 2 Hours [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Levels of Gingival crevicular fluid Interleukin - 1 (GCF IL-1)(weight in micrograms)

  • Level of Gingival Crevicular Fluid Interleukin - 6(GCF IL-6) at 2 Hours [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Levels of Gingival crevicular fluid Interleukin - 6 (GCF IL-6) (weight in micrograms)


Enrollment: 49
Study Start Date: January 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Total Toothpaste
Triclosan/Copolymer/fluoride toothpaste
Drug: Triclosan/Copolymer/fluoride toothpaste
Twice daily usage
Other Name: Total toothpaste
Placebo Comparator: Fluoride toothpaste
sodium monofluorophosphate toothpaste
Drug: sodium monofluorophosphate toothpaste
Twice daily usage
Other Name: Colgate cavity protection toothpaste

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00941668

Locations
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
Colgate Palmolive
Investigators
Principal Investigator: David Paquette, DMD
  More Information

Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00941668     History of Changes
Other Study ID Numbers: CRO-1005-INF-UNC-FP 
Study First Received: September 26, 2008
Results First Received: September 26, 2008
Last Updated: August 18, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Inflammation
Gingivitis
Pathologic Processes
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Fluorides
Fluorophosphate
Triclosan
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on July 21, 2016