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Clinical Examination of Metal Free Interdental Brushes

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ClinicalTrials.gov Identifier: NCT01593540
Recruitment Status : Completed
First Posted : May 8, 2012
Last Update Posted : May 8, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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 Design

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
Primary Completion Date : August 2011
Study Completion Date : September 2011
Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01593540


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

Responsible Party: Johan Wölber, DDS, Principal investigator, Dr., University of Freiburg
ClinicalTrials.gov 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:
Periodontitis
Gingivitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Gingival Diseases