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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014