Efficacy and Safety Study of Interproximal Cleaning Modalities on Oral Health

Not Applicable

Completed

Conditions: Gingivitis

Interventions: Device: AirFloss + Listerine
Device: Dental Floss
Device: AirFloss + BreathRx
Device: Manual Toothbrush

Registration Number: NCT02187016

Lead Sponsor: Philips Oral Healthcare

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 290

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AirFloss + Listerine	AirFloss + Listerine	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.
Dental Floss	Dental Floss	Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute. Subjects used interproximal cleaning device once a day.
AirFloss + BreathRx	AirFloss + BreathRx	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.
Manual Toothbrush	Manual Toothbrush	Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute

Primary Outcome Measures

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

Secondary Outcome Measures

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