Clinical Examination of Metal Free Interdental Brushes

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01593540
• Other study ID #: woel-01
• 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

• Gingivitis
• Periodontitis

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