Evaluating the Effect of Tooth Cleaning Devices on Oral Health

August 21, 2012 updated by: Philips Oral Healthcare

Evaluating the Effect of a Novel Interproximal Cleaning Device on Oral Health

This is a study to evaluate the safety and the efficacy of tooth and interproximal cleaning modalities on oral health.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • University Park Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • are in good/excellent health;
  • are 18 - 70 years old;
  • have a minimum of 20 natural teeth (excluding 3rd molars);
  • have sufficient test sites;
  • have ≥ 20 bleeding sites;
  • are willing to participate and available for participation.

Exclusion Criteria:

  • have systemic diseases such as Down's syndrome, or known AIDS/HIV;
  • have insulin dependant Diabetes;
  • are pregnant or nursing by subject report;
  • have a cardiac pacemaker
  • are undergoing or require extensive dental or orthodontic treatment;
  • require antibiotic treatment for dental appointments;
  • have heavy deposits of calculus;
  • have severe gingivitis or periodontitis;
  • have extensive crown or bridge work and/or rampant decay;
  • currently use bleaching trays;
  • have any oral or extraoral piercing on lips or in mouth;
  • have a professional prophylaxis within 4 weeks of study;
  • participation in a prior study ≤ 20 days;
  • employed by a oral healthcare products company or research institution.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Manual Toothbrush 1
Manual Toothbrush used for 1 minute twice a day
Device: Manual Toothbrush
A standard size manual toothbrush to clean visible tooth surfaces
Other Names:
  • ADA Reference Toothbrush
Active Comparator: Manual Toothbrush 2
Manual Toothbrush used for 2 minutes twice a day
Device: Manual Toothbrush
A standard size manual toothbrush to clean visible tooth surfaces
Other Names:
  • ADA Reference Toothbrush
Experimental: Manual Toothbrush + Interproximal Cleaning 1
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day
Device: Manual Toothbrush
A standard size manual toothbrush to clean visible tooth surfaces
Other Names:
  • ADA Reference Toothbrush
Device: Interproximal Cleaning Device
An electronic device that combines water and air to clean between the teeth
Other Names:
  • Philips AirFloss
Experimental: Manual Toothbrush + Interproximal Cleaning 2
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day
Device: Manual Toothbrush
A standard size manual toothbrush to clean visible tooth surfaces
Other Names:
  • ADA Reference Toothbrush
Device: Interproximal Cleaning Device
An electronic device that combines water and air to clean between the teeth
Other Names:
  • Philips AirFloss

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Residual Protein Concentration
Time Frame: 14 days
Residual protein concentration of interproximal plaque samples
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Residual Protein Concentration
Time Frame: 28 days
Residual protein concentration of interproximal plaque samples
28 days
Modified Gingival Index
Time Frame: 14 days
Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)
14 days
Modified Gingival Index
Time Frame: 28 days
Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)
28 days
Gingival Bleeding Index
Time Frame: 14 days
Gingival bleeding evaluation using an ordinal scale of 0 to 3; (0 is best; 3 is worst)
14 days
Gingival Bleeding Index
Time Frame: 28 days
Gingival bleeding evaluation using a ordinal scale of 0 to 3; (0 is best; 3 is worst)
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Oral Healthcare

Investigators

  • Study Director: Wendy Jenkins, POHC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

May 5, 2010

First Submitted That Met QC Criteria

November 29, 2010

First Posted (Estimate)

December 1, 2010

Study Record Updates

Last Update Posted (Estimate)

September 19, 2012

Last Update Submitted That Met QC Criteria

August 21, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRC-0703

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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