Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Clinical Examination of Metal Free Interdental Brushes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johan Wölber, DDS, Principal investigator, University of Freiburg
ClinicalTrials.gov Identifier:
NCT01593540
First received: April 28, 2012
Last updated: May 7, 2012
Last verified: May 2012

April 28, 2012
May 7, 2012
September 2010
August 2011   (final data collection date for primary outcome measure)
Analysis of the differences between both groups. Measurements in form of Plaque-Index (Quigley und Hein, Tureskey Mod. 1970) [ Time Frame: Beginning and after four weeks of use ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01593540 on ClinicalTrials.gov Archive Site
Eastman Interdental Bleeding Index, questionnaire of patient acceptance [ Time Frame: Beginning and after four weeks of use ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Clinical Examination of Metal Free Interdental Brushes
Clinical Efficacy and Patient Acceptance of Metal and Metal-Free Interdental Brushes: A Controlled Prospective Randomized Study

The aim of the study was to evaluate the clinical efficacy (Eastman Interdental Bleeding Index, Quigley and Hein) of a novel metal-free interdentalbrush compared to a classig metal-core interdental brush.

Self-performed interdental cleaning is a crucial element in preventing gingival or periodontal diseases. Interdental cleaning is most efficiently performed through usage of interdental brushes. Commonly used metal-core interdental brushes can harbour the risk of hard tissue damage when used inappropriately.The aim of the study was to evaluate the clinical efficacy and patient satisfaction of a novel metal-free interdental brush. This was tested on healthy participants. The control group performed interdental cleaning with a commonly used metal-core interdental brush.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
  • Gingivitis
  • Periodontitis
  • Device: metal-free interdental brush
    one time per day
    Other Name: Fuchs brush&clean
  • Device: metal-core interdental brush
    one time per day
    Other Name: TePe Interdental brushes
  • Experimental: metal-free interdental brushes.
    Intervention: Device: metal-free interdental brush
  • Active Comparator: metal-core interdental brushes
    Intervention: Device: metal-core interdental brush
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
September 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • minimum age: 18 years

Exclusion Criteria:

  • allergy against one or more parts of the interdental brushes
  • non-treated periodontitis
  • soft-tissue changes of the mucosa
  • orthodontic treatment
  • removable prosthesis
  • pregnancy
  • anticoagulants
  • drugs causing gingivahyperplasia
  • indications for antibiotics
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01593540
woel-01
No
Johan Wölber, DDS, Principal investigator, University of Freiburg
University of Freiburg
Not Provided
Study Director: Johan P Woelber, Dr. University of Freiburg
University of Freiburg
May 2012

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