Back to resultsClinical Examination of Metal Free Interdental Brushes
Primary Purpose
Gingivitis, Periodontitis
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
metal-free interdental brush
metal-core interdental brush
Sponsored by
About this trial
This is an interventional supportive care trial for Gingivitis
Eligibility Criteria
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
Sites / Locations
- University Freiburg Medical Center , Dept of Operative Dentistry and Periodontology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
metal-free interdental brushes.
metal-core interdental brushes
Arm Description
Outcomes
Primary Outcome Measures
Analysis of the differences between both groups. Measurements in form of Plaque-Index (Quigley und Hein, Tureskey Mod. 1970)
Secondary Outcome Measures
Eastman Interdental Bleeding Index, questionnaire of patient acceptance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01593540
Brief Title
Clinical Examination of Metal Free Interdental Brushes
Official Title
Clinical Efficacy and Patient Acceptance of Metal and Metal-Free Interdental Brushes: A Controlled Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Freiburg
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Periodontitis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
metal-free interdental brushes.
Arm Type
Experimental
Arm Title
metal-core interdental brushes
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
metal-free interdental brush
Other Intervention Name(s)
Fuchs brush&clean
Intervention Description
one time per day
Intervention Type
Device
Intervention Name(s)
metal-core interdental brush
Other Intervention Name(s)
TePe Interdental brushes
Intervention Description
one time per day
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Eastman Interdental Bleeding Index, questionnaire of patient acceptance
Time Frame
Beginning and after four weeks of use
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan P Woelber, Dr.
Organizational Affiliation
University of Freiburg
Official's Role
Study Director
Facility Information:
Facility Name
University Freiburg Medical Center , Dept of Operative Dentistry and Periodontology
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Clinical Examination of Metal Free Interdental Brushes
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