Effect of Shock Waves on Dental Parameters

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

Effect of Low-energy Extracorporeal Shock Waves on Periodontal and Endodontic Parameters

This randomized clinical trial investigates the effect of the extracorporeal shockwave therapy (ESWT) on periodontal and endodontical parameters. The ESWT is a scientifically approved non invasive method to influence bone turnover and tissue regeneration. The hypotheses of this trial are that ESWT increases the periodontal stability of orthodontically aligned teeth as well as increase the blood flow. Increasing the periodontal stability would reduce the retention phase, relapse risk and accelerate the rehabilitation of the surrounding tissues.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

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

  • Austria
      • 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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy patients which don´t fulfill the exclusion criteria

Exclusion Criteria:

  • diseases (syndroms, infections,...) which influence the bone turnover and blood flow
  • medication, which influences the bone turnover and blood flow
  • 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: ESWT
Extracorporeal shockwave therapy
Device: Extracorporeal shockwave therapy
1000 impulses
Other Names:
  • Orthogold 100 MTS
Placebo Comparator: ESWT Placebo
No extracorporeal shockwave therapy
Device: No extracorporeal shockwave
0 impulses, acoustic effect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
periodontal stability of orthodontically aligned teeth
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
pulpal blood flow
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

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.

General Publications

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, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

May 14, 2012

First Submitted That Met QC Criteria

May 14, 2012

First Posted (Estimate)

May 16, 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

Keywords

Other Study ID Numbers

  • ESWT1

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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