Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis

Study Overview
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Brief Summary
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The objective of this study is to evaluate the performance of two toothpastes in controlling established gingivitis and dental plaque in adults.

Official Title
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Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis

Conditions
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Gingivitis

Intervention / Treatment
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* Drug: Triclosan, fluoride
* Drug: Fluoride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Availability for the six-month duration of the study. Good general health. Minimum of 20 uncrowned permanent natural teeth (excluding third molars). Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index. Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification). Signed Informed Consent Form. Exclusion Criteria: Presence of orthodontic bands. Presence of partial removable dentures. Tumor(s) of the soft or hard tissues of the oral cavity. Advanced periodontal disease (purulent exudate,tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone). Five or more carious lesions requiring immediate restorative treatment. Use of antibiotics any time during the one month prior to entry into the study. Participation in any other clinical study or test panel within the one month prior to entry into the study. Pregnant women or women who are breast feeding. Receive a dental prophylaxis in the past two weeks prior to baseline examinations. History of allergic to personal care/consumer products or their ingredients. Taking any prescription medicines. That might interfere with the study outcome. Individuals with an existing medical condition which prohibits them from not eating or drinking for periods up to 4 hours.

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A -Experimental toothpaste<br>triclosan/copolymer/fluoride toothpaste | Drug: Triclosan, fluoride<br>* Six Month study, brush twice daily<br>* Other names: Colgate Total Advanced Freshening toothpaste;|
| Placebo Comparator: B - control toothpaste<br>sodium fluoride only toothpaste (placebo) | Drug: Fluoride<br>* twice daily usage<br>* Other names: Crest Cavity Protection toothpaste;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingivitis Index | Units on a scale 0 to 3 (0 = no inflammation , 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) | 6 months | 
| Plaque Index | Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gingivitis and Plaque