Evaluate Dental Plaque Benefit of a Preventive Treatment Gel

Study Overview
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Brief Summary
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The objective of the study is to evaluate anti-plaque efficacy of a preventive treatment gel in a modified 4-day plaque model.

Official Title
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A Clinical Study to Evaluate Anti-Plaque Benefit of a Gel in a Modified- 4 Day Plaque Model

Conditions
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Dental Plaque

Intervention / Treatment
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* Drug: Preventive Gel
* Drug: Marketed Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide written informed consent prior to participation and be given a signed copy of the informed consent form; Be 18 years of age or older; Agree not to participate in any other oral/dental product studies during the study; Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed; Agree to refrain from the use of any non-study oral hygiene products (subjects who are regular flossers will be allowed to floss during acclimation and wash-out periods); Agree to use an oral hygiene product that contains stannous fluoride; Agree to refrain from any form of non-specified oral hygiene during the treatment period, including the use of products such as floss, toothpicks for plaque removal, and chewing gum; Agree to refrain from any oral hygiene, eating and drinking after 11:00 PM the evening before plaque measurements on Day 0 and Day 4 of the treatment periods; Agree to return for all scheduled visits and follow study procedures; Possess a minimum of 20 natural teeth with scorable facial and lingual surfaces, of which at least 4 are molars; and, Be in good general health, as determined by the Investigator/designee based on a review of the health history/update for participation in the study. Exclusion Criteria:• Have a medical condition requiring pre-medication prior to dental procedures; Have taken antibiotics within 2 weeks of the acclimation period or anticipate taking antibiotics at any time during the study; Have a history of allergies or hypersensitivity to dyes or dentifrices that contain stannous fluoride; Have removable or orthodontic appliances which interfere with obtaining 20 gradable teeth; Have previously demonstrated an inability to comply with study visit requirements; Have rampant caries, open or untreated caries, severe gingivitis or advanced periodontitis requiring prompt treatment; or, Present with any disease or condition(s) that could be expected to interfere with examination procedures or the subject's safe completion of the study.

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preventive Gel<br>0.4% stannous fluoride | Drug: Preventive Gel<br>* 0.4% Stannous Fluoride<br>|
| Active Comparator: Marketed Control<br>0.243 % Sodium Fluoride | Drug: Marketed Control<br>* 0.243% Sodium Fluoride<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Turesky Modified Quigley-Hein Index at Day 4 | The Turesky Modified Quigley-Hein Index was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual and mesiolingual) to assess plaque on all gradable teeth. Whole mouth average plaque scores were calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. the scoring criteria is below; (0) No Plaque; (1) Separate flecks of plaque at the cervical margin; (2) A thin, continuous band of plaque (up to 1 mm) at the cervical margin; (3) A band of plaque wider than 1 mm, but covering less than one third of the side of the crown of the tooth; (4) Plaque covering at least one third, but less than two thirds of the side of the crown of the tooth; (5) Plaque covering two thirds or more of the side of the crown of the tooth. | Day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Turesky Modified Quigley-Hein Index at Baseline | The Turesky Modified Quigley-Hein Index was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual and mesiolingual) to assess plaque on all gradable teeth. Whole mouth average plaque scores were calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. the scoring criteria is below; (0) No Plaque; (1) Separate flecks of plaque at the cervical margin; (2) A thin, continuous band of plaque (up to 1 mm) at the cervical margin; (3) A band of plaque wider than 1 mm, but covering less than one third of the side of the crown of the tooth; (4) Plaque covering at least one third, but less than two thirds of the side of the crown of the tooth; (5) Plaque covering two thirds or more of the side of the crown of the tooth. | Baseline | 
| Digital Plaque Imaging | Total percent dental plaque area | Day 4 | 
| Overall Baseline Mean Digital Plaque Imaging | Total percent dental plaque area | Baseline |