Clinical Examination of Metal Free Interdental Brushes | NCT01593540

Studies
Clinical Examination of Metal Free Interdental Brushes

NCT01593540

Sponsor

University of Freiburg

Status

Completed

Last Update Posted

May 8, 2012Estimated

Enrollment

39Actual

Phase

Phase 4

Conditions

Gingivitis
Periodontitis

Interventions

metal-free interdental brush
metal-core interdental brush

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Aug 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Apr 28, 2012

First Submission Date that Met QC Criteria

May 7, 2012

First Posted Date

May 8, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2012

Last Update Posted Date

May 8, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
metal-free interdental brushes.	Experimental		Device: metal-free interdental brush
metal-core interdental brushes	Active Comparator		Device: metal-core interdental brush

Interventions

Name	Type	Description	Arm Group Labels	Other Names
metal-free interdental brush	Device	one time per day	metal-free interdental brushes.

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Johan P Woelber, Dr.	University of Freiburg	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Freiburg Medical Center , Dept of Operative Dentistry and Periodontology		Freiburg im Breisgau		79106	Germany

Condition Browse Module

MeSH Terms

ID	Term
D005891	Gingivitis
D010518	Periodontitis

Ancestor Terms

ID	Term
D007239	Infections
D005882	Gingival Diseases
D010510	Periodontal Diseases
D009059	Mouth Diseases

Browse Leaves

Not provided

Browse Branches

Not provided