A Clinical Study to Assess the Gingivitis and Plaque Effects of Various Dentifrices

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the effect four different dentifrices have on gingivitis after 12 weeks of product use. The secondary objectives are to assess the effect four dentifrices, have on plaque and oral microbiome composition.

Official Title
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A Three-Month Clinical Study to Assess the Gingivitis and Plaque Effects of Various Dentifrices

Conditions
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Gingivitis

Intervention / Treatment
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* Drug: 0.76% Sodium Monofluorophosphate Dentifrice
* Drug: 0.454% Stannous Fluoride Dentifrice
* Drug: 0.454% Stannous Fluoride Dentifrice
* Drug: 0.454% Stannous Fluoride Dentifrice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years of age; Provide written informed consent prior to participation and be given a signed copy of the informed consent form; Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial; Have at least 16 gradable teeth; Have mild to moderate gingivitis with at least 20 bleeding sites; Agree to return for scheduled visits and follow the study procedures; Agree to refrain from use of any non-study oral hygiene products for the duration of the study; Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study; Agree to refrain from any oral hygiene the morning of your visit Agree to refrain from eating, drinking (except water), using tobacco, floss, use toothpicks, breath mints, or chew gum after performing your evening brushing. Exclusion Criteria: Having taken antibiotic, anti-inflammatory, or anti-coagulant medications within 4 weeks of the Baseline Visit; Have any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease; Having had a dental prophylaxis within 2 weeks of plaque sampling visits; Removable oral appliances; Fixed facial or lingual orthodontic appliances; Self-reported pregnancy or lactation; Any diseases or condition that might interfere with the safe participation in the study; and Inability to undergo study procedures.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: 0.76% Sodium Monofluorophosphate Dentifrice<br> | Drug: 0.76% Sodium Monofluorophosphate Dentifrice<br>* Whole mouth brushing with a toothpaste, twice daily for the duration of the study.<br>|
| Active Comparator: Marketed 0.454% Stannous Fluoride plus Arginine Dentifrice<br> | Drug: 0.454% Stannous Fluoride Dentifrice<br>* Whole mouth brushing with a toothpaste, twice daily for the duration of the study.<br>|
| Active Comparator: Marketed 0.454% Stannous Fluoride Dentifrice<br> | Drug: 0.454% Stannous Fluoride Dentifrice<br>* Whole mouth brushing with a toothpaste, twice daily for the duration of the study.<br>|
| Active Comparator: 0.454% Stannous Fluoride Dentifrice<br> | Drug: 0.454% Stannous Fluoride Dentifrice<br>* Whole mouth brushing with a toothpaste, twice daily for the duration of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Löe-Silness Gingivitis Evaluation | Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation). | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Löe-Silness Gingivitis Evaluation | Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation). | Baseline | 
| Löe-Silness Gingivitis Evaluation | Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation). | 1 Month | 
| Mean Turesky Modified Quigley-Hein Index | 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 | 
| Mean Turesky Modified Quigley-Hein Index | 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. | 1 Month | 
| Mean Turesky Modified Quigley-Hein Index | 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. | 3 Months |