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

January 11, 2016 updated by: Janet Kinney, University of Michigan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Michigan Center for Oral Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Colgate total toothpaste

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Plaque Index (Silness & Loe 1964) to Day 35
Time Frame: Baseline to 35 Days
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.
Baseline to 35 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Gingival Index (Loe & Silness 1963) to Day 35
Time Frame: Baseline to 35 Days
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.
Baseline to 35 Days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unstimulated Whole Saliva Will be Collected for Inflammatory Biomarker Expression.
Time Frame: Baseline to 35 Days
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).
Baseline to 35 Days
Plaque Samples Will be Collected for Bacterial Species Detection.
Time Frame: Baseline to 35 Days
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.
Baseline to 35 Days
Gingival Crevicular Fluid (GCF) Will be Collected for Inflammatory Biomarker Expression.
Time Frame: Baseline to 35 Days
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.
Baseline to 35 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Janet Kinney, MS, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 24, 2013

First Submitted That Met QC Criteria

February 24, 2013

First Posted (Estimate)

February 26, 2013

Study Record Updates

Last Update Posted (Estimate)

January 13, 2016

Last Update Submitted That Met QC Criteria

January 11, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00055445

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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