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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janet Kinney, University of Michigan
ClinicalTrials.gov Identifier:
NCT01799226
First received: February 24, 2013
Last updated: January 11, 2016
Last verified: January 2016
  Purpose
This study evaluates the anti-inflammatory effects of Colgate Total® during an experimental gingivitis model developed by Löe et al. Half of the participants will use Colgate Total® (which contains triclosan), while the other half will use a toothpaste which does not contain triclosan as the control.

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: Double Blind (Subject, 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:
  • Change From Baseline in Plaque Index (Silness & Loe 1964) to Day 35 [ Time Frame: Baseline to 35 Days ] [ Designated as safety issue: No ]
    Silness & Loe 1964 is a score of 0-3 with 0 = No plaque, 1 = A film of plaque adhering to free gingival margin and adjacent area of tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface, 2 = Moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, which can be seen with the naked eye, 3 = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. This index was used at days 0, 14, 21 and 35.


Secondary Outcome Measures:
  • Change From Baseline in Gingival Index (Loe & Silness 1963) to Day 35 [ Time Frame: Baseline to 35 Days ] [ Designated as safety issue: No ]
    Loe & Silness 1963 is a score of 0-3 with 0 = Absence of inflammation, 1 = Mild inflammation, slight change in color and texture, 2 = Moderate inflammation, glazing, redness, edema and hypertrophy, 3 = Severe inflammation, redness and hypertrophy, ulceration. This index was used at days 0, 14, 21 and 35.


Other Outcome Measures:
  • Unstimulated Whole Saliva Will be Collected for Inflammatory Biomarker Expression. [ Time Frame: Baseline to 35 Days ] [ Designated as safety issue: No ]
    Inflammatory biomarker expression will be quantified using a custom human 10-complex protein array that is optimized for sensitivity, specificity, stability, and intraassay coefficient of variation by comparing to single cytokine enzyme-linked immunosorbent assays (Quantibody Custom Array, RayBiotech, Norcross, GA).

  • Plaque Samples Will be Collected for Bacterial Species Detection. [ Time Frame: Baseline to 35 Days ] [ Designated as safety issue: No ]
    Supra- and sub-gingival plaque samples will be gently collected using a sterile curet and a one stroke method from two randomized sites within the stent area. The detection of 40 bacterial species will be evaluated by the checkerboard DNA-DNA hybridization technique originally described by Socransky et al. 1994.

  • Gingival Crevicular Fluid (GCF) Will be Collected for Inflammatory Biomarker Expression. [ Time Frame: Baseline to 35 Days ] [ Designated as safety issue: No ]
    A total of 10 biomarkers will be analyzed based on the results from Lee and colleagues: IL-1α, IL-1β, IL-6, IL-8, IL-10, MCP-1, MMP-8, MMP-9, TIMP-1, and TIMP-2.


Enrollment: 32
Study Start Date: March 2013
Study Completion Date: December 2013
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. Subjects will be randomly assigned to the test or control dentifrice arm. Enrolled subjects will also be randomly assigned to either right or left side mandibular stent.

During the induction phase (i.e., day 0 to day 21), participants are instructed to refrain from all hygiene procedures in the stent area. During this time period, participants evenly distributed 2mL of their assigned dentifrice into their stent, allowing it to come into contact with the areas of experimental gingivitis for two minutes twice daily while traditional tooth brushing was performed in the non-stent areas. Clinical measures, saliva, gingival crevicular fluid and plaque samples will be collected at days 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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
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 1-4mm 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

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
Results First Received: July 23, 2015
Last Updated: January 11, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on December 08, 2016