Clinical Examination of Metal Free Interdental Brushes

Phase 4

Completed

• Conditions: Gingivitis; Periodontitis
• Interventions: Device: metal-free interdental brush; Device: metal-core interdental brush

• Registration Number: NCT01593540
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-09
• Primary Completion: 2011-08
• Study Completion: 2011-09
• Study First Submitted: 2012-04-28
• Status Verified: 2012-05
• Study First Submitted QC: 2012-05-07
• Last Update Submitted: 2012-05-07
• Study First Posted: 2012-05-08
• Last Update Posted: 2012-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
metal-free interdental brushes.	metal-free interdental brush	-
metal-core interdental brushes	metal-core interdental brush	-

Primary Outcome Measures

Name	Time	Method
Analysis of the differences between both groups. Measurements in form of Plaque-Index (Quigley und Hein, Tureskey Mod. 1970)	Beginning and after four weeks of use

Secondary Outcome Measures

Name	Time	Method
Eastman Interdental Bleeding Index, questionnaire of patient acceptance	Beginning and after four weeks of use

Trial Locations

Locations (1)

University Freiburg Medical Center , Dept of Operative Dentistry and Periodontology; 🇩🇪 Freiburg, Germany