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Clinical Trials/NCT01593540
NCT01593540
Completed
Phase 4

Clinical Efficacy and Patient Acceptance of Metal and Metal-Free Interdental Brushes: A Controlled Prospective Randomized Study

University of Freiburg1 site in 1 country39 target enrollmentSeptember 2010

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Gingivitis
Sponsor
University of Freiburg
Enrollment
39
Locations
1
Primary Endpoint
Analysis of the differences between both groups. Measurements in form of Plaque-Index (Quigley und Hein, Tureskey Mod. 1970)
Status
Completed
Last Updated
13 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
September 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Johan Wölber, DDS, Principal investigator

Dr.

University of Freiburg

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • Eastman Interdental Bleeding Index, questionnaire of patient acceptance(Beginning and after four weeks of use)

Study Sites (1)

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