Evaluating the Effect of Tooth Cleaning Devices on Oral Health

Study Overview
=================
Brief Summary
-----------------
This is a study to evaluate the safety and the efficacy of tooth and interproximal cleaning modalities on oral health.

Official Title
-----------------
Evaluating the Effect of a Novel Interproximal Cleaning Device on Oral Health

Conditions
-----------------
Dental Plaque

Intervention / Treatment
-----------------
* Device: Manual Toothbrush
* Device: Interproximal Cleaning Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: are in good/excellent health; are 18 - 70 years old; have a minimum of 20 natural teeth (excluding 3rd molars); have sufficient test sites; have ≥ 20 bleeding sites; are willing to participate and available for participation. Exclusion Criteria: have systemic diseases such as Down's syndrome, or known AIDS/HIV; have insulin dependant Diabetes; are pregnant or nursing by subject report; have a cardiac pacemaker are undergoing or require extensive dental or orthodontic treatment; require antibiotic treatment for dental appointments; have heavy deposits of calculus; have severe gingivitis or periodontitis; have extensive crown or bridge work and/or rampant decay; currently use bleaching trays; have any oral or extraoral piercing on lips or in mouth; have a professional prophylaxis within 4 weeks of study; participation in a prior study ≤ 20 days; employed by a oral healthcare products company or research institution.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manual Toothbrush 1<br>Manual Toothbrush used for 1 minute twice a day | Device: Manual Toothbrush<br>* A standard size manual toothbrush to clean visible tooth surfaces<br>* Other names: ADA Reference Toothbrush;|
| Active Comparator: Manual Toothbrush 2<br>Manual Toothbrush used for 2 minutes twice a day | Device: Manual Toothbrush<br>* A standard size manual toothbrush to clean visible tooth surfaces<br>* Other names: ADA Reference Toothbrush;|
| Experimental: Manual Toothbrush + Interproximal Cleaning 1<br>Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day | Device: Manual Toothbrush<br>* A standard size manual toothbrush to clean visible tooth surfaces<br>* Other names: ADA Reference Toothbrush;Device: Interproximal Cleaning Device<br>* An electronic device that combines water and air to clean between the teeth<br>* Other names: Philips AirFloss;|
| Experimental: Manual Toothbrush + Interproximal Cleaning 2<br>Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day | Device: Manual Toothbrush<br>* A standard size manual toothbrush to clean visible tooth surfaces<br>* Other names: ADA Reference Toothbrush;Device: Interproximal Cleaning Device<br>* An electronic device that combines water and air to clean between the teeth<br>* Other names: Philips AirFloss;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual Protein Concentration | Residual protein concentration of interproximal plaque samples | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual Protein Concentration | Residual protein concentration of interproximal plaque samples | 28 days | 
| Modified Gingival Index | Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst) | 14 days | 
| Modified Gingival Index | Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst) | 28 days | 
| Gingival Bleeding Index | Gingival bleeding evaluation using an ordinal scale of 0 to 3; (0 is best; 3 is worst) | 14 days | 
| Gingival Bleeding Index | Gingival bleeding evaluation using a ordinal scale of 0 to 3; (0 is best; 3 is worst) | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental, dentist, plaque, IP Cleaning