Philips AirFlosser Study

NCT01700348 | Terminated Results

• 2 other identifiers: MAH-12-008110438
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 1

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

Keywords

moderate gingivitis

Outcome Measures

Primary Outcomes (1)

• The Effect of Sonicare AirFloss + MTB Treatment Versus the Control Group

  The primary objective of the study is to compare the effect of Sonicare AirFloss + MTB treatment versus the Control Group on gingival inflammation (as measure by number of bleeding sites, and reduction in MGI) after four weeks of use.

  Four Months

Secondary Outcomes (5)

• Gingival Inflammation

  4 weeks

• Number of Bleeding Sites

  2 Weeks

• Plaque

  4 Weeks

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  4 Months

• Percentage of Bleeding Sites

  2 Weeks

Study Arms (2)

Airflosser

EXPERIMENTAL

Use of Airflosser

Device: Airflosser

Manual Floss

ACTIVE COMPARATOR

Normal Routine

Device: Manual Floss

Interventions

Airflosser DEVICE

Use of Philips Airflosser

Also known as: Philips Airflosser

Airflosser

Manual Floss DEVICE

Active Comparator

Manual Floss

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Tufts University: lead
• Philips Oral Healthcare: collaborator

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Limitations and Caveats

Terminated by sponsor due to: * Changes in business strategy/Target completion dates not being met * Higher than anticipated screen failure rate * Higher than anticipated early termination rate * Large number of protocol deviations encountered

Results Point of Contact

• Title: Marcia Delaurenti, Clinical Project Manager
• Organization: Philips Oral Healthcare, Inc

marcia.delaurenti@philips.com

425-908-1212

Study Officials

• Gerard Kugel, DMD, MS, PhD

  TUSDM

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2012
• First Posted: October 4, 2012
• Study Start: August 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: August 6, 2019
• Results First Posted: May 29, 2015

Record last verified: 2019-07

Locations

US (1)