Effect of Shock Waves on Tooth Movement and Miniscrew Stability

October 9, 2015 updated by: Frank Falkensammer, DMD,DMS, Medical University of Vienna

Effect of Low-energy Extracorporeal Shock Waves on Orthodontic Tooth Movement and Miniscrew Stability

The low-energy extracorporal shockwave is a scientifically approved method to activate respectively increase bone-turnover processes especially in orthopedic medicine. The aim of this clinical study is to apply this effect in orthodontic dentistry and evaluate the orthodontic tooth movement respectively miniscrew stability clinically.

This randomized clinical study is carried out in orthodontic patients undergoing space closure therapy at the university clinic of dentistry. During this period the tooth movement rate as well as the miniscrew stability are evaluated consecutively chairside.

Study Overview

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Vienna, Austria, 1090
        • Bernhard Gottlieb University clinic of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy patients which don´t fulfill the exclusion criteria

Exclusion Criteria:

  • disease (syndroms,infections,...) which influence the bone turnover and the oral health
  • medication, which influences the bone turnover and the oral health
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Extracorporeal shockwave therapy (ESWT)
Active treatment
1000 impulses
Other Names:
  • Orthogold 100 MTS
Placebo Comparator: ESWT Placebo
No extracoporeal shockwave therapy
0 impulses, acoustic effect
Other Names:
  • Orthogold 100 MTS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Orthodontic tooth movement
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Miniscrew stability
Time Frame: 4 months
4 months

Other Outcome Measures

Outcome Measure
Time Frame
Periodontal status
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Hans P Bantleon, Prof, M.D., Bernhard Gottlieb University Clinic of Dentistry, Department of Orthodontics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

September 26, 2012

First Submitted That Met QC Criteria

September 26, 2012

First Posted (Estimate)

September 28, 2012

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

October 9, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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