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

May 5, 2010
August 21, 2012
April 2010
June 2010   (final data collection date for primary outcome measure)
Residual Protein Concentration [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Residual protein concentration of interproximal plaque samples
Residual Protein Concentration in Interproximal Plaque [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Floss Sampling, protein quantification
Complete list of historical versions of study NCT01250769 on ClinicalTrials.gov Archive Site
  • 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)
  • Modified Gingival Index [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Gingival inflammation evaluation
  • Gingival Bleeding Index [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Gingival bleeding evaluation
  • Modified Gingival Index [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Gingival inflammation evaluation
  • Gingival Bleeding Index [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Gingival bleeding evaluation
  • Residual Protein Concentration in Interproximal Plaque [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Evaluating the Effect of Tooth Cleaning Devices on Oral Health
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Dental Plaque
  • 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
  • Active Comparator: Manual Toothbrush 1
    Manual Toothbrush used for 1 minute twice a day
    Intervention: Device: Manual Toothbrush
  • Active Comparator: Manual Toothbrush 2
    Manual Toothbrush used for 2 minutes twice a day
    Intervention: Device: Manual Toothbrush
  • Experimental: Manual Toothbrush + Interproximal Cleaning 1
    Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day
    Interventions:
    • Device: Manual Toothbrush
    • Device: Interproximal Cleaning Device
  • Experimental: Manual Toothbrush + Interproximal Cleaning 2
    Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day
    Interventions:
    • Device: Manual Toothbrush
    • Device: Interproximal Cleaning Device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
170
June 2010
June 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01250769
DRC-0703
No
Philips Oral Healthcare
Philips Oral Healthcare
Not Provided
Study Director: Wendy Jenkins POHC
Philips Oral Healthcare
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP