Effect of Shock Waves on Tooth Movement and Miniscrew Stability

NCT ID: NCT01695928

Last Updated: 2015-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Mesial Movement of Teeth Miniscrew Stability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Extracorporeal shockwave therapy (ESWT)

Active treatment

Group Type ACTIVE_COMPARATOR

Extracorporeal shockwave therapy

Intervention Type DEVICE

1000 impulses

ESWT Placebo

No extracoporeal shockwave therapy

Group Type PLACEBO_COMPARATOR

ESWT placebo

Intervention Type DEVICE

0 impulses, acoustic effect

Interventions

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Extracorporeal shockwave therapy

1000 impulses

Intervention Type DEVICE

ESWT placebo

0 impulses, acoustic effect

Intervention Type DEVICE

Other Intervention Names

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Orthogold 100 MTS Orthogold 100 MTS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Frank Falkensammer, DMD,DMS

DMD,DMS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hans P Bantleon, Prof, M.D.

Role: STUDY_CHAIR

Bernhard Gottlieb University Clinic of Dentistry, Department of Orthodontics

Locations

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Bernhard Gottlieb University clinic of Dentistry

Vienna, Vienna, Austria

Site Status

Countries

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Austria

References

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Sathishkumar S, Meka A, Dawson D, House N, Schaden W, Novak MJ, Ebersole JL, Kesavalu L. Extracorporeal shock wave therapy induces alveolar bone regeneration. J Dent Res. 2008 Jul;87(7):687-91. doi: 10.1177/154405910808700703.

Reference Type RESULT
PMID: 18573992 (View on PubMed)

Martini L, Giavaresi G, Fini M, Torricelli P, de Pretto M, Schaden W, Giardino R. Effect of extracorporeal shock wave therapy on osteoblastlike cells. Clin Orthop Relat Res. 2003 Aug;(413):269-80. doi: 10.1097/01.blo.0000073344.50837.cd.

Reference Type RESULT
PMID: 12897619 (View on PubMed)

Hazan-Molina H, Kaufman H, Reznick ZA, Aizenbud D. [Orthodontic tooth movement under extracorporeal shock wave therapy: the characteristics of the inflammatory reaction--a preliminary study]. Refuat Hapeh Vehashinayim (1993). 2011 Jul;28(3):55-60, 71. Hebrew.

Reference Type RESULT
PMID: 21939106 (View on PubMed)

Falkensammer F, Rausch-Fan X, Arnhart C, Krall C, Schaden W, Freudenthaler J. Impact of extracorporeal shock-wave therapy on the stability of temporary anchorage devices in adults: a single-center, randomized, placebo-controlled clinical trial. Am J Orthod Dentofacial Orthop. 2014 Oct;146(4):413-22. doi: 10.1016/j.ajodo.2014.06.008.

Reference Type DERIVED
PMID: 25263143 (View on PubMed)

Other Identifiers

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ESWT2

Identifier Type: -

Identifier Source: org_study_id

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