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OpenTrials
Completed

NCT Number: NCT00941668

Evaluate Inflammation Caused by Gingivitis in Adults

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

Completed

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Triclosan/Copolymer/fluoride toothpaste

Drug

Twice daily usage

Other names: Total toothpaste

Sodium monofluorophosphate toothpaste

Drug

Twice daily usage

Other names: Colgate cavity protection toothpaste

Primary outcomes

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

    Time frame: 4 weeks

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

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

    Time frame: 4 weeks

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

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 17, 2009
Registry last updated
Aug 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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