Evaluating the Effect of Tooth Cleaning Devices on Oral Health

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Philips Oral Healthcare
ClinicalTrials.gov Identifier:
NCT01250769
First received: May 5, 2010
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention
Dental Plaque
Device: Manual Toothbrush
Device: Interproximal Cleaning Device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating the Effect of a Novel Interproximal Cleaning Device on Oral Health

Resource links provided by NLM:


Further study details as provided by Philips Oral Healthcare:

Primary Outcome Measures:
  • Residual Protein Concentration [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Residual protein concentration of interproximal plaque samples


Secondary Outcome Measures:
  • Residual Protein Concentration [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Residual protein concentration of interproximal plaque samples

  • Modified Gingival Index [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)

  • Modified Gingival Index [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)

  • Gingival Bleeding Index [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Gingival bleeding evaluation using an ordinal scale of 0 to 3; (0 is best; 3 is worst)

  • Gingival Bleeding Index [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Gingival bleeding evaluation using a ordinal scale of 0 to 3; (0 is best; 3 is worst)


Enrollment: 170
Study Start Date: April 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: ADA Reference Toothbrush
Device: Interproximal Cleaning Device
An electronic device that combines water and air to clean between the teeth
Other Name: 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 Name: ADA Reference Toothbrush
Device: Interproximal Cleaning Device
An electronic device that combines water and air to clean between the teeth
Other Name: Philips AirFloss

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01250769

Locations
United States, Indiana
University Park Research Center
Fort Wayne, Indiana, United States, 46825
Sponsors and Collaborators
Philips Oral Healthcare
Investigators
Study Director: Wendy Jenkins POHC
  More Information

No publications provided

Responsible Party: Philips Oral Healthcare
ClinicalTrials.gov Identifier: NCT01250769     History of Changes
Other Study ID Numbers: DRC-0703
Study First Received: May 5, 2010
Results First Received: May 31, 2012
Last Updated: August 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Philips Oral Healthcare:
dental
dentist
plaque
IP Cleaning

Additional relevant MeSH terms:
Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on April 17, 2014