Efficacy and Safety Study of Interproximal Cleaning Modalities on Oral Health

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

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Device: AirFloss + BreathRx; Device: AirFloss + Listerine; Device: Dental Floss; Device: Manual Toothbrush

• Study Type: Interventional
• Enrollment (Actual): 290
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89146
      • Silverstone Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: AirFloss + BreathRx; Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.
Experimental: 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.	Device: AirFloss + Listerine; Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.
Experimental: 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.	Device: Dental Floss; Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning used once daily.
Active Comparator: Manual Toothbrush; Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute	Device: Manual Toothbrush; Manual Toothbrush used twice daily, 1 minute.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Philips Oral Healthcare
• Investigators: Principal Investigator: Pejmon Amini, DDS, Silverston Research Group

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: July 1, 2014
• First Submitted That Met QC Criteria: July 7, 2014
• First Posted (Estimate): July 10, 2014

Study Record Updates

• Last Update Posted (Estimate): March 8, 2016
• Last Update Submitted That Met QC Criteria: February 5, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: plaque; Gingivitis; dental floss; interproximal cleaning
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis; Anti-Infective Agents, Local; Anti-Infective Agents; Listerine
• Other Study ID Numbers: MAH-13-0151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO