Clinical Examination of Metal Free Interdental Brushes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01593540
Recruitment Status : Completed
First Posted : May 8, 2012
Last Update Posted : May 8, 2012
Information provided by (Responsible Party):
Johan Wölber, DDS, Principal investigator, University of Freiburg

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gingivitis Periodontitis Device: metal-free interdental brush Device: metal-core interdental brush Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Clinical Efficacy and Patient Acceptance of Metal and Metal-Free Interdental Brushes: A Controlled Prospective Randomized Study
Study Start Date : September 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : September 2011

Arm Intervention/treatment
Experimental: metal-free interdental brushes. Device: metal-free interdental brush
one time per day
Other Name: Fuchs brush&clean

Active Comparator: metal-core interdental brushes Device: metal-core interdental brush
one time per day
Other Name: TePe Interdental brushes

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Eastman Interdental Bleeding Index, questionnaire of patient acceptance [ Time Frame: Beginning and after four weeks of use ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01593540

University Freiburg Medical Center , Dept of Operative Dentistry and Periodontology
Freiburg, Germany, 79106
Sponsors and Collaborators
University of Freiburg
Study Director: Johan P Woelber, Dr. University of Freiburg

Responsible Party: Johan Wölber, DDS, Principal investigator, Dr., University of Freiburg Identifier: NCT01593540     History of Changes
Other Study ID Numbers: woel-01
First Posted: May 8, 2012    Key Record Dates
Last Update Posted: May 8, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Gingival Diseases