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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
  Purpose

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 Intervention Phase
Gingivitis
Periodontitis
Device: metal-free interdental brush
Device: metal-core interdental brush
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (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

Further study details as provided by University of Freiburg:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Eastman Interdental Bleeding Index, questionnaire of patient acceptance [ Time Frame: Beginning and after four weeks of use ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: September 2010
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Johan Wölber, DDS, Principal investigator, Dr., University of Freiburg
ClinicalTrials.gov Identifier: NCT01593540     History of Changes
Other Study ID Numbers: woel-01
Study First Received: April 28, 2012
Last Updated: May 7, 2012
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on November 23, 2014