Efficacy and Safety Study of Interproximal Cleaning Modalities on Oral Health

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of tooth and interproximal cleaning modalities with and without chemistry on oral health over 28 days.

Official Title
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A Randomized, Parallel Design Study to Assess the Effects of Three Interproximal Cleaning Modalities Versus a Manual Toothbrush Control on Gingivitis and Plaque Following a Period of Home Use

Conditions
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Gingivitis

Intervention / Treatment
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* Device: AirFloss + BreathRx
* Device: AirFloss + Listerine
* Device: Dental Floss
* Device: Manual Toothbrush


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be willing and physically able to carry out all study procedures and be available at all times required for participation Be able to fully understand and comply with the written and verbal instructions provided Provide written Informed Consent Be age 18 - 65 years Agree to return study materials at the required visits Be a non-smoker Have a minimum of 20 'scorable' teeth (excluding 3rd molars) Have a minimum average plaque score of > 0.5 per RMNPI scoring with 2-6 hours of plaque accumulation Have a Gingival Bleeding Index of ->1 on at least 10 sites Be a regular manual toothbrush user Be a non or irregular flosser defined as using dental floss or any other interproximal cleaning technique once per week or less often Exclusion Criteria: A medical or dental condition that would be unduly affected by participation in this study, per Investigator discretion Pregnant or nursing per subject report A medical condition requiring antibiotic pre-medication prior to dental appointments Diagnosis of xerostomia Any oral or extra oral piercing that interferes with the ability to perform study procedures and/or clinical assessments in the mouth Currently undergoing or requiring dental/periodontal treatment, or having had periodontal treatment in the six months preceding the study, where the subject's study participation could present an undue safety risk or obscure the evaluation of study endpoints, per Investigator /Examiner discretion Oral surgery within the last 2 months Current use of professionally dispensed bleaching products A known allergy or sensitivity to products planned for use in this study Unwillingness to abstain from all other oral hygiene products other than those prescribed for the duration of the study Unwillingness to abstain from all other oral hygiene products other than those prescribed for the duration of the study Participation in an oral care study within the previous 90 days Be an employee or a relative of an employee of the Site clinical research department, dental school, or a dental products manufacturing, research or marketing firm Are a dental student or dental professional A cardiac pacemaker or implanted cardiac defibrillator Insulin-Dependent Diabetes Current use of antibiotic medications or use within 4 weeks of enrollment Current use of prescription-dose anti-inflammatory medications or anticoagulants; (including aspirin > 81 mg daily) Presence of advanced periodontal disease or excessive gingival recession, per Investigator/Examiner discretion Heavy deposits of calculus, either supragingival and/or subgingival, per Investigator/Examiner discretion Extensive crown or bridge work and/or rampant decay, per Investigator/Examiner discretion Presence of orthodontic bands interfering with efficacy outcome(s) per Investigator/Examiner discretion Have a professional prophylaxis within 4 weeks of the study Be a regular power toothbrush user

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: AirFloss + BreathRx<br>Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute. Subjects used interproximal cleaning device with BreathRx rinse once a day. | Device: AirFloss + BreathRx<br>* Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.<br>|
| Experimental: AirFloss + Listerine<br>Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute. Subjects used interproximal cleaning device with Listerine Cool Mint rinse once a day. | Device: AirFloss + Listerine<br>* Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.<br>|
| Experimental: Dental Floss<br>Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute. Subjects used interproximal cleaning device once a day. | Device: Dental Floss<br>* Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning used once daily.<br>|
| Active Comparator: Manual Toothbrush<br>Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute | Device: Manual Toothbrush<br>* Manual Toothbrush used twice daily, 1 minute.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14 | MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation). | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28 | MGI is a validated assessment of Gingival inflammation using a 4 point scale from 0 (absence of inflammation) to 4 (severe inflammation). | 28 days | 
| Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14 | GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding). | 14 days | 
| Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28 | GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding). | 28 days | 
| Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14 | RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence). | 14 days | 
| Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28 | RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence). | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gingivitis, plaque, interproximal cleaning, dental floss