NCT01593540

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 8, 2012

Completed
Last Updated

May 8, 2012

Status Verified

May 1, 2012

Enrollment Period

11 months

First QC Date

April 28, 2012

Last Update Submit

May 7, 2012

Conditions

GingivitisPeriodontitis

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Eastman Interdental Bleeding Index, questionnaire of patient acceptance

    Beginning and after four weeks of use

Study Arms (2)

metal-free interdental brushes.

EXPERIMENTAL
Device: metal-free interdental brush

metal-core interdental brushes

ACTIVE COMPARATOR
Device: metal-core interdental brush

Interventions

metal-free interdental brushDEVICE

one time per day

Also known as: Fuchs brush&clean
metal-free interdental brushes.
metal-core interdental brushDEVICE

one time per day

Also known as: TePe Interdental brushes
metal-core interdental brushes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • minimum age: 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Freiburg Medical Center , Dept of Operative Dentistry and Periodontology

Freiburg im Breisgau, 79106, Germany

Location

MeSH Terms

Conditions

GingivitisPeriodontitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Johan P Woelber, Dr.

    University of Freiburg

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 28, 2012

First Posted

May 8, 2012

Study Start

September 1, 2010

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

May 8, 2012

Record last verified: 2012-05

Locations

DE(1)