Efficacy and Safety Study of Interproximal Cleaning Modalities on Oral Health

NCT ID: NCT02187016

Last Updated: 2016-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 290 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-07-31

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.

Conditions

Gingivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

AirFloss + BreathRx

Intervention Type: DEVICE

Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.

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.

Group Type: EXPERIMENTAL

AirFloss + Listerine

Intervention Type: DEVICE

Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.

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.

Group Type: EXPERIMENTAL

Dental Floss

Intervention Type: DEVICE

Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning used once daily.

Manual Toothbrush

Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute

Group Type: ACTIVE_COMPARATOR

Manual Toothbrush

Intervention Type: DEVICE

Manual Toothbrush used twice daily, 1 minute.

Interventions

AirFloss + BreathRx

Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.

Intervention Type: DEVICE

AirFloss + Listerine

Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.

Intervention Type: DEVICE

Dental Floss

Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning used once daily.

Intervention Type: DEVICE

Manual Toothbrush

Manual Toothbrush used twice daily, 1 minute.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Philips Oral Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pejmon Amini, DDS

Role: PRINCIPAL_INVESTIGATOR

Silverston Research Group

Locations

Silverstone Research Group

Las Vegas, Nevada, United States

Countries

United States

Other Identifiers

MAH-13-0151

Identifier Type: -

Identifier Source: org_study_id