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Completed

NCT Number: NCT01593540

Clinical Examination of Metal Free Interdental Brushes

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.

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Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Freiburg Medical Center , Dept of Operative Dentistry and Periodontology

Freiburg im Breisgau, 79106, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metal-free interdental brush

Device

one time per day

Other names: Fuchs brush&clean

metal-core interdental brush

Device

one time per day

Other names: TePe Interdental brushes

Primary outcomes

  1. Analysis of the differences between both groups. Measurements in form of Plaque-Index (Quigley und Hein, Tureskey Mod. 1970)

    Time frame: Beginning and after four weeks of use

Secondary outcomes

  1. Eastman Interdental Bleeding Index, questionnaire of patient acceptance

    Time frame: Beginning and after four weeks of use

Sponsors and collaborators

Lead sponsor

University of Freiburg

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 8, 2012
Registry last updated
May 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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