Compare Anti-inflammatory Dentifrices

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00762528
First received: September 26, 2008
Last updated: March 5, 2012
Last verified: March 2012
  Purpose

Plaque induced gingivitis


Condition Intervention Phase
Gingivitis
Drug: Triclosan, Fluoride
Drug: Fluoride
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: Compare Anti-inflammatory Dentifrices

Resource links provided by NLM:


Further study details as provided by Colgate Palmolive:

Primary Outcome Measures:
  • Gingival Index (GI) [ Time Frame: 29 days ] [ Designated as safety issue: No ]

    Gingival Index(GI)recorded on scale of 0-3 detailed below:

    0=normal gingiva, 1=Mild inflammation(slight change in color, slight edema)no bleeding on palpation,2=Moderate inflammation(redness,edema,glazing)bleeding upon probing, 3=Severe inflammation(marked redness,edema)ulceration & tendency to spontaneously bleed


  • Prostaglandin E2 (PGE2) [ Time Frame: 29 days ] [ Designated as safety issue: No ]
    Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.

  • Interleukin - 1 Beta (IL-ß) [ Time Frame: 29 days ] [ Designated as safety issue: No ]
    Inflammatory biomarkers found in gingival crevicular fluid (GCF) that may be a factor in oral tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.

  • Interleukin-6 (IL-6) [ Time Frame: 29 days ] [ Designated as safety issue: No ]
    Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.

  • Nuclear Factor Kappa B Ligand (RANK-L) [ Time Frame: 29 days ] [ Designated as safety issue: No ]
    Receptor activator found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.

  • 8-iso-prostaglandinF2α (8-iso-PGF2α) [ Time Frame: 29 days ] [ Designated as safety issue: No ]
    Inflammatory biomarker found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.


Secondary Outcome Measures:
  • Dental Plaque Index (PI) [ Time Frame: 29 days ] [ Designated as safety issue: No ]
    measurement of supragingival dental plaque on scale of 0-3. 0=No plaque in gingival area,1=a film of plaque adhering to the free gingival margin and the adjacent tooth,2=Moderate accumulation of soft deposits within the gingival pocket and on the gingival margin and/or adjacent tooth-visible by the naked eye, 3=Abundance of soft matter within the gingival pocket and/or gingival margin and adjacent tooth surfaces.

  • Bleeding on Probing (BOP) [ Time Frame: 29 days ] [ Designated as safety issue: No ]
    Presence or absence of bleeding to manual probing as a dichotomous variable as follows: 0 = No bleeding within 10 seconds after probing, 1 = Bleeding within 10 seconds after probing.


Enrollment: 49
Study Start Date: February 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Total Toothpaste
Triclosan/Copolymer/fluoride toothpaste
Drug: Triclosan, Fluoride
Twice daily usage
Other Name: Toothpaste includes triclosan/fluoride/co-polymer (Total)
Placebo Comparator: Fluoride toothpaste Drug: Fluoride
Twice daily usage
Other Name: fluoride only toothpaste

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
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 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.
  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: NCT00762528

Locations
United States, North Carolina
East Carolina University, Brody School of Medicine
Greenville, North Carolina, United States, 27834
Sponsors and Collaborators
Colgate Palmolive
Investigators
Principal Investigator: Sara G Grossi, DDS
  More Information

No publications provided

Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00762528     History of Changes
Other Study ID Numbers: CRO-1107-INF-ECU-FP
Study First Received: September 26, 2008
Results First Received: March 5, 2012
Last Updated: March 5, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Inflammatory Agents
Fluorides
Triclosan
Therapeutic Uses
Pharmacologic Actions
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 31, 2014