Clinical Examination of Metal Free Interdental Brushes

University of Freiburg

Status and phase: Completed; Phase 4

Conditions: Periodontitis; Gingivitis

Treatments: Device: metal-free interdental brush; Device: metal-core interdental brush

Study type: Interventional

Funder types: Other

Identifiers

NCT01593540

woel-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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39 participants in 2 patient groups

metal-free interdental brushes.

Experimental group

Treatment:

Device: metal-free interdental brush

metal-core interdental brushes

Active Comparator group

Treatment:

Device: metal-core interdental brush