Philips AirFlosser Study

NCT ID: NCT01700348

Last Updated: 2019-08-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 257 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-02-28

Brief Summary

In the current study, Sonicare AirFloss (AF) will be used in combination with a Manual Toothbrush (MTB) in a population of manual toothbrush users who are irregular flossers and who exhibit signs of moderate gingivitis. The alternate test arm will be allocated to a No Intervention group and will be given no test products or instruction other than to change none of their typical at home oral hygiene habits.

The aim of this study is to investigate how an AF and MTB oral hygiene intervention will affect a population of irregular flossers using the residual protein concentration method as an interproximal plaque efficacy assessment. Gingivitis reduction will be assessed using the Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) indices

Conditions

Gingivitis

Study Design

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

Study Groups

Airflosser

Use of Airflosser

Group Type: EXPERIMENTAL

Airflosser

Intervention Type: DEVICE

Use of Philips Airflosser

Manual Floss

Normal Routine

Group Type: ACTIVE_COMPARATOR

Manual Floss

Intervention Type: DEVICE

Active Comparator

Interventions

Airflosser

Use of Philips Airflosser

Intervention Type: DEVICE

Manual Floss

Active Comparator

Intervention Type: DEVICE

Other Intervention Names

Philips Airflosser

Eligibility Criteria

Inclusion Criteria

Subjects accepted into the study must meet the following requirements:

• are 18-70 years;
• are in generally good health;
• have a minimum of 20 natural teeth (excluding 3rd molars);
• have 1 qualifying test site in each posterior quadrant;
• are a regular manual toothbrush user (prior periodic use of powered toothbrushes in other studies permitted);
• Irregular Flossers defined as using dental floss ≤ 2 days a week;
• be willing and able to comply with study procedures and be available at all times required for participation;
• have a Gingival Bleeding Index > 1 on at least 20 sites;
• be a non-smoker.

Exclusion Criteria

• have systemic diseases such as Down's syndrome, or known AIDS/HIV;
• have insulin dependent Diabetes;
• are pregnant or nursing by subject report;
• have a cardiac pacemaker or AICD;
• are undergoing or require extensive dental or orthodontic treatment;
• require antibiotic treatment for dental appointments;
• have used antibiotics within 4 weeks of enrollment;
• are currently using prescription-dose anti-inflammatory medications or anticoagulants (including aspirin);
• have heavy deposits of calculus, either supragingival and/or subgingival;
• have severe gingivitis or periodontitis;
• have extensive crown or bridge work and/or rampant decay;
• are currently use bleaching trays;
• have any oral or extraoral piercing on lips or in mouth with ornament or accessory;
• have a professional prophylaxis within 4 weeks of study;
• have participated in a prior study ≤ 20 days;
• are employed by an oral healthcare products company or dental research institution.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Philips Oral Healthcare

INDUSTRY

Sponsor Role: collaborator

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerard Kugel, DMD, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

TUSDM

Locations

Tufts University School of Dental Medicine

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

10438

Identifier Type: OTHER

Identifier Source: secondary_id

MAH-12-0081

Identifier Type: -

Identifier Source: org_study_id