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Effect of Shock Waves on Tooth Movement and Miniscrew Stability

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Frank Falkensammer, DMD,DMS, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01695928
First received: September 26, 2012
Last updated: April 16, 2013
Last verified: April 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Shock
U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Orthodontic tooth movement [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Miniscrew stability [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Periodontal status [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: September 2012
Estimated Study Completion Date: December 2013
Estimated 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:

Responsible Party: Frank Falkensammer, DMD,DMS, DMD,DMS, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01695928     History of Changes
Other Study ID Numbers: ESWT2
Study First Received: September 26, 2012
Last Updated: April 16, 2013
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
Velocity
Location
Periodontal status

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

ClinicalTrials.gov processed this record on June 18, 2013