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Effect of Shock Waves on Tooth Movement and Miniscrew Stability

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01695928
First Posted: September 28, 2012
Last Update Posted: October 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Frank Falkensammer, DMD,DMS, Medical University of Vienna
  Purpose

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.


Condition Intervention Phase
Mesial Movement of Teeth Miniscrew Stability Device: Extracorporeal shockwave therapy Device: ESWT placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Low-energy Extracorporeal Shock Waves on Orthodontic Tooth Movement and Miniscrew Stability

Resource links provided by NLM:


Further study details as provided by Frank Falkensammer, DMD,DMS, Medical University of Vienna:

Primary Outcome Measures:
  • Orthodontic tooth movement [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • Miniscrew stability [ Time Frame: 4 months ]

Other Outcome Measures:
  • Periodontal status [ Time Frame: 4 months ]

Enrollment: 30
Study Start Date: September 2012
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Extracorporeal shockwave therapy (ESWT)
Active treatment
Device: Extracorporeal shockwave therapy
1000 impulses
Other Name: Orthogold 100 MTS
Placebo Comparator: ESWT Placebo
No extracoporeal shockwave therapy
Device: ESWT placebo
0 impulses, acoustic effect
Other Name: Orthogold 100 MTS

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695928


Locations
Austria
Bernhard Gottlieb University clinic of Dentistry
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Study Chair: Hans P Bantleon, Prof, M.D. Bernhard Gottlieb University Clinic of Dentistry, Department of Orthodontics
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Frank Falkensammer, DMD,DMS, DMD,DMS, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01695928     History of Changes
Other Study ID Numbers: ESWT2
First Submitted: September 26, 2012
First Posted: September 28, 2012
Last Update Posted: October 12, 2015
Last Verified: October 2015

Keywords provided by Frank Falkensammer, DMD,DMS, Medical University of Vienna:
Velocity
Location
Periodontal status

Additional relevant MeSH terms:
Mesial Movement of Teeth
Tooth Migration
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases