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Evaluating the Effect of Tooth Cleaning Devices on Oral Health

Primary Purpose

Dental Plaque

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manual Toothbrush
Interproximal Cleaning Device
Sponsored by
Philips Oral Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Plaque focused on measuring dental, dentist, plaque, IP Cleaning

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Park Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Arm Label

Manual Toothbrush 1

Manual Toothbrush 2

Manual Toothbrush + Interproximal Cleaning 1

Manual Toothbrush + Interproximal Cleaning 2

Arm Description

Manual Toothbrush used for 1 minute twice a day

Manual Toothbrush used for 2 minutes twice a day

Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day

Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day

Outcomes

Primary Outcome Measures

Residual Protein Concentration
Residual protein concentration of interproximal plaque samples

Secondary Outcome Measures

Residual Protein Concentration
Residual protein concentration of interproximal plaque samples
Modified Gingival Index
Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)
Modified Gingival Index
Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)
Gingival Bleeding Index
Gingival bleeding evaluation using an ordinal scale of 0 to 3; (0 is best; 3 is worst)
Gingival Bleeding Index
Gingival bleeding evaluation using a ordinal scale of 0 to 3; (0 is best; 3 is worst)

Full Information

First Posted
May 5, 2010
Last Updated
August 21, 2012
Sponsor
Philips Oral Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT01250769
Brief Title
Evaluating the Effect of Tooth Cleaning Devices on Oral Health
Official Title
Evaluating the Effect of a Novel Interproximal Cleaning Device on Oral Health
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Oral Healthcare

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque
Keywords
dental, dentist, plaque, IP Cleaning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual Toothbrush 1
Arm Type
Active Comparator
Arm Description
Manual Toothbrush used for 1 minute twice a day
Arm Title
Manual Toothbrush 2
Arm Type
Active Comparator
Arm Description
Manual Toothbrush used for 2 minutes twice a day
Arm Title
Manual Toothbrush + Interproximal Cleaning 1
Arm Type
Experimental
Arm Description
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day
Arm Title
Manual Toothbrush + Interproximal Cleaning 2
Arm Type
Experimental
Arm Description
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day
Intervention Type
Device
Intervention Name(s)
Manual Toothbrush
Other Intervention Name(s)
ADA Reference Toothbrush
Intervention Description
A standard size manual toothbrush to clean visible tooth surfaces
Intervention Type
Device
Intervention Name(s)
Interproximal Cleaning Device
Other Intervention Name(s)
Philips AirFloss
Intervention Description
An electronic device that combines water and air to clean between the teeth
Primary Outcome Measure Information:
Title
Residual Protein Concentration
Description
Residual protein concentration of interproximal plaque samples
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Residual Protein Concentration
Description
Residual protein concentration of interproximal plaque samples
Time Frame
28 days
Title
Modified Gingival Index
Description
Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)
Time Frame
14 days
Title
Modified Gingival Index
Description
Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)
Time Frame
28 days
Title
Gingival Bleeding Index
Description
Gingival bleeding evaluation using an ordinal scale of 0 to 3; (0 is best; 3 is worst)
Time Frame
14 days
Title
Gingival Bleeding Index
Description
Gingival bleeding evaluation using a ordinal scale of 0 to 3; (0 is best; 3 is worst)
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Jenkins
Organizational Affiliation
POHC
Official's Role
Study Director
Facility Information:
Facility Name
University Park Research Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States

12. IPD Sharing Statement

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Evaluating the Effect of Tooth Cleaning Devices on Oral Health

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