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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01593540
Other study ID # woel-01
Secondary ID
Status Completed
Phase Phase 4
First received April 28, 2012
Last updated May 7, 2012
Start date September 2010
Est. completion date September 2011

Study information

Verified date May 2012
Source University of Freiburg
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date September 2011
Est. primary completion date August 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Device:
metal-free interdental brush
one time per day
metal-core interdental brush
one time per day

Locations

Country Name City State
Germany University Freiburg Medical Center , Dept of Operative Dentistry and Periodontology Freiburg

Sponsors (1)

Lead Sponsor Collaborator
University of Freiburg

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Eastman Interdental Bleeding Index, questionnaire of patient acceptance Beginning and after four weeks of use No
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