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Study of the Anti-Inflammatory Effects of Colgate Total® During an Experimental Gingivitis Model

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janet Kinney, University of Michigan
ClinicalTrials.gov Identifier:
NCT01799226
First received: February 24, 2013
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

The overall objective of this proposal is to examine the anti-inflammatory effects of Colgate Total® during an experimental gingivitis model.


Condition Intervention
Gingivitis
Other: Toothpaste without triclosan
Other: Triclosan

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Study of the Anti-Inflammatory Effects of Colgate Total® During an Experimental Gingivitis Model

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • anti-inflammatory effects [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    The following ten biomarkers will be analyzed in saliva and Gingival crevicular fluid: IL-1α, IL-1β, IL-6, IL-8, IL-10, MCP-1, MMP-8, MMP-9, TIMP-1, TIMP-2.


Secondary Outcome Measures:
  • clinical measures [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    Plaque and gingival indices will be monitored


Enrollment: 32
Study Start Date: March 2013
Estimated Study Completion Date: June 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Toothpaste without Triclosan
This arm will use a toothpaste that does not contain triclosan
Other: Toothpaste without triclosan
this intervention will use a toothpaste without triclosan
Experimental: Triclosan
This arm will use colgate total which contains triclosan
Other: Triclosan
this intervention will use Colgate Total which contains triclosan
Other Name: Colgate total toothpaste

Detailed Description:

This will be a double-blind, parallel group study utilizing the experimental gingivitis model. Subjects will be randomly assigned to an arm of the study. Enrolled subjects will also be randomly assigned to either right or left side mandibular stent.

Saliva and gingival crevicular fluid and plaque samples will be collected at Day 0, 14, 21, and 35 study visits. A randomization chart will be used to identify which two sites (teeth and tooth surface) will be used at the specific study visit for collection of gingival crevicular fluid(GCF)and plaque. Gingival crevicular fluid (GCF) and plaque samples will not be taken from implants. If one of the posterior teeth is missing, the cuspid tooth will be used as a substitute tooth. Repeat gingival crevicular fluid (GCF) samples will be taken at Day 14, and 21.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Race - all
  • Gender - female or male
  • Age - 18 to 40 years old
  • Dentition - minimum of 20 permanent teeth
  • Probing Pocket Depth of 4mm in all sites
  • Mean Clinical Attachment Levels of 2mm on all teeth
  • Bleeding Upon Probing of greater than 30% at Day -14 Study Visit
  • Consent Form - read, understood, and signed
  • Study Procedures - willing to follow all study procedures
  • At Day 0 Study Visit, all subjects must have a BOP of less than 10%. Subjects not meeting the BOP study criteria will be asked to return in 2 weeks for a second assessment visit. Subjects who do not meet the inclusion criteria
  • BOP less than 10% at the second assessment visit will be exited from the
  • study

Exclusion Criteria:

  • Medical History - a history of alcoholism or drug abuse
  • Diseases of the immune system
  • Medical condition that may affect outcome (neurologic or psychiatric disorders, systemic infection
  • Medications - chronic medications known to affect the periodontal status (calcium antagonists anticonvulsives, immunosuppressives, anti-inflammatory medications, phenytoin, Depo-Provera contraceptive injection users
  • New oral contraceptives users within 3 months of baseline or are planning on starting oral contraceptives during the study
  • Hypersensitivity - previous known reaction to or oral allergy to any ingredient in the study toothpaste
  • Antibiotics - antibiotic therapy within 3 months of baseline visit
  • antibiotic therapy needed for infective endocarditis prophylaxis or total joint replacement
  • Use of antiseptics - homecare regime using products to control dental plaque formation within 30 days prior to baseline visit
  • Smoking - current smokers, smokers who quit smoking less than one year ago, or a pack-year history of more than or equal to 10 (pack-years will be calculated by multiplying the number of years smoked by the average number of cigarette packs smoked per day)
  • Continine - positive urine analysis results
  • Current Dental Treatment - orthodontic or periodontal treatment
  • Untreated Dental Treatment - untreated carious lesions
  • Defective restorations which could exacerbate during a period of oral hygiene abstinence
  • Pregnant or women breast-feeding
  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: NCT01799226

Locations
United States, Michigan
Michigan Center for Oral Health Research
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Janet Kinney, MS University of Michigan
  More Information

No publications provided

Responsible Party: Janet Kinney, Assistant Professor of Dentistry, Director of Dental Hygiene Program, University of Michigan
ClinicalTrials.gov Identifier: NCT01799226     History of Changes
Other Study ID Numbers: HUM00055445
Study First Received: February 24, 2013
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Gingivitis
Gingival Diseases
Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases
Anti-Inflammatory Agents
Listerine
Sodium Fluoride
Triclosan
Anti-Infective Agents
Anti-Infective Agents, Local
Antimetabolites
Cariostatic Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014