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Completed

NCT Number: NCT00762528

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Plaque induced gingivitis

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

East Carolina University, Brody School of Medicine

Greenville, North Carolina, 27834, 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 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.

Treatment and study plan

Triclosan/Copolymer/fluoride toothpaste

Drug

Twice daily usage

Other names: Toothpaste includes triclosan/fluoride/co-polymer (Total)

Sodium monofluorophosphate toothpaste

Drug

Twice daily usage

Other names: fluoride only toothpaste

Primary outcomes

  1. Gingival Index (GI)

    Time frame: 29 days

    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

  2. Prostaglandin E2 (PGE2)

    Time frame: 29 days

    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.

  3. Interleukin - 1 Beta (IL-ß)

    Time frame: 29 days

    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.

  4. Interleukin-6 (IL-6)

    Time frame: 29 days

    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.

  5. Nuclear Factor Kappa B Ligand (RANK-L)

    Time frame: 29 days

    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.

  6. 8-iso-prostaglandinF2α (8-iso-PGF2α)

    Time frame: 29 days

    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 outcomes

  1. Dental Plaque Index (PI)

    Time frame: 29 days

    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.

  2. Bleeding on Probing (BOP)

    Time frame: 29 days

    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.

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 30, 2008
Registry last updated
Sep 10, 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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