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Effect of Shock Waves on Tooth Movement and Miniscrew Stability

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ClinicalTrials.gov Identifier: NCT01695928
Recruitment Status : Completed
First Posted : September 28, 2012
Last Update Posted : October 12, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Mesial Movement of Teeth Miniscrew Stability Device: Extracorporeal shockwave therapy Device: ESWT placebo Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Study Start Date : September 2012
Primary Completion Date : December 2013
Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

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

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

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

Eligibility Criteria

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

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

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

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 Posted: September 28, 2012    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015

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

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