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Trial record 15 of 43 for:    FLUORIDE ION AND TRICLOSAN

To Access the Effects of Mucositis in Adults With Dental Implants (implantitis)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01072201
Recruitment Status : Completed
First Posted : February 19, 2010
Results First Posted : February 19, 2010
Last Update Posted : October 5, 2010
Information provided by:
Colgate Palmolive

Brief Summary:
Clinical research for the treatment of mucositis subjects who have dental implants for a minimum of one-year.

Condition or disease Intervention/treatment Phase
Mucositis Drug: Triclosan and Fluoride Drug: Fluoride Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: To Access the Effects of Mucositis in Adults With Dental Implants
Study Start Date : June 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Total toothpaste
Triclosan/copolymer/fluoride toothpaste
Drug: Triclosan and Fluoride
Brush twice daily
Other Name: Total Toothpaste

Placebo Comparator: Ultrabrite toothpaste
Fluoride Toothpaste
Drug: Fluoride
Brush twice daily
Other Name: Ultrabrite toothpaste

Primary Outcome Measures :
  1. Bleeding on Probing [ Time Frame: 6 months ]
    Percentage of Bleeding Scale: The bleeding sites are identified by either a 0 or 1. (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored.

  2. Mean Pocket Depth [ Time Frame: 6 Months ]
    Measurement scale: 0 millimeter measurement= no pocket depth. 3, 4, 5, & 6 millimeter are indications of deeper Pocket depth.

  3. Mean Percentage of Plaque Scores [ Time Frame: 6 Months ]
    Mean Percentage (%) of dental plaque on all tooth surfaces, including implants and natural teeth. Plaque Scale is 0=no plaque and 1= dental plaque present. Percentage is derived from sum of all plaque scores divided by the number of tooth surfaces scored.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Male and female subjects, ages 30-70.
  • Availability for the six-month duration of the clinical research study.
  • Good general health.
  • Subjects who have lost teeth for periodontal disease reasons and who have been restored with implants.
  • Minimum of 5 remaining teeth and a minimum of 2 implants.
  • Initial evaluation of the gingival and peri-implant mucosal tissues by determining full mouth bleeding on probing.
  • Initial plaque evaluation by determining full mouth presence/absence of plaque.
  • Signed Informed Consent Form.

Exclusion Criteria:

  • Tumor(s) of the soft or hard tissues of the oral cavity.
  • Untreated periodontal disease (purulent exudate, tooth mobility, and/or extensive loss or periodontal attachment or alveolar bone).
  • Carious lesions requiring immediate restorative treatment.
  • Uncontrolled Diabetes
  • Use of antibiotics any time during the one month prior to entry into the study.
  • Untreated peri-implantitis.
  • Participation in any other clinical research study or test panel within the three months prior to entry into the study.
  • Pregnant women or women who are breast feeding.
  • History of allergies to personal care/consumer products or their ingredients.
  • Medical condition which prohibits not eating/drinking for up to 2 hours.
  • Current alcohol or drug abuse.
  • Systemic or local disease conditions that would compromise post-operative healing.
  • Regular use of anti-inflammatory drugs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01072201

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Ariminum Research & Dental Education Center
Rimini, Italy
Sponsors and Collaborators
Colgate Palmolive
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Principal Investigator: Per Ramberg, DDS

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Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive Identifier: NCT01072201     History of Changes
Other Study ID Numbers: CRO-0107-PERIO-MUC-ITA-PC
First Posted: February 19, 2010    Key Record Dates
Results First Posted: February 19, 2010
Last Update Posted: October 5, 2010
Last Verified: September 2010
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents