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
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
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on April 17, 2014