To Access the Effects of Mucositis in Adults With Dental Implants

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

Official Title
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To Access the Effects of Mucositis in Adults With Dental Implants

Conditions
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Mucositis

Intervention / Treatment
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* Drug: Triclosan and Fluoride
* Drug: Fluoride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Total toothpaste<br>Triclosan/copolymer/fluoride toothpaste | Drug: Triclosan and Fluoride<br>* Brush twice daily<br>* Other names: Total Toothpaste;|
| Placebo Comparator: Ultrabrite toothpaste<br>Fluoride Toothpaste | Drug: Fluoride<br>* Brush twice daily<br>* Other names: Ultrabrite toothpaste;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding on Probing | 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. | 6 months | 
| Mean Pocket Depth | Measurement scale: 0 millimeter measurement= no pocket depth. 3, 4, 5, & 6 millimeter are indications of deeper Pocket depth. | 6 Months | 
| Mean Percentage of Plaque Scores | 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. | 6 Months |