Clinical Examination of Metal Free Interdental Brushes

NCT ID: NCT01593540

Last Updated: 2012-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-09-30

Brief Summary

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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

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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.

Conditions

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Gingivitis Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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metal-free interdental brushes.

Group Type EXPERIMENTAL

metal-free interdental brush

Intervention Type DEVICE

one time per day

metal-core interdental brushes

Group Type ACTIVE_COMPARATOR

metal-core interdental brush

Intervention Type DEVICE

one time per day

Interventions

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metal-free interdental brush

one time per day

Intervention Type DEVICE

metal-core interdental brush

one time per day

Intervention Type DEVICE

Other Intervention Names

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Fuchs brush&clean TePe Interdental brushes

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Freiburg

OTHER

Sponsor Role lead

Responsible Party

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Johan Wölber, DDS, Principal investigator

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Johan P Woelber, Dr.

Role: STUDY_DIRECTOR

University of Freiburg

Locations

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University Freiburg Medical Center , Dept of Operative Dentistry and Periodontology

Freiburg im Breisgau, , Germany

Site Status

Countries

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Germany

Other Identifiers

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woel-01

Identifier Type: -

Identifier Source: org_study_id

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