Clinical Examination of Metal Free Interdental Brushes

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01593540

Enrollment

Registered

2012-05-08

Start date

2010-09-30

Completion date

2011-09-30

Last updated

2012-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingivitis, Periodontitis

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.

Interventions

DEVICEmetal-free interdental brush

one time per day

DEVICEmetal-core interdental brush

one time per day

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026