NCT01695928

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

October 12, 2015

Status Verified

October 1, 2015

Enrollment Period

1.2 years

First QC Date

September 26, 2012

Last Update Submit

October 9, 2015

Conditions

Mesial Movement of TeethMiniscrew Stability

Keywords

VelocityLocationPeriodontal status

Outcome Measures

Primary Outcomes (1)

  • Orthodontic tooth movement

    4 months

Secondary Outcomes (1)

  • Miniscrew stability

    4 months

Other Outcomes (1)

  • Periodontal status

    4 months

Study Arms (2)

Extracorporeal shockwave therapy (ESWT)

ACTIVE COMPARATOR

Active treatment

Device: Extracorporeal shockwave therapy

ESWT Placebo

PLACEBO COMPARATOR

No extracoporeal shockwave therapy

Device: ESWT placebo

Interventions

Extracorporeal shockwave therapyDEVICE

1000 impulses

Also known as: Orthogold 100 MTS
Extracorporeal shockwave therapy (ESWT)
ESWT placeboDEVICE

0 impulses, acoustic effect

Also known as: Orthogold 100 MTS
ESWT Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • disease (syndroms,infections,...) which influence the bone turnover and the oral health
  • medication, which influences the bone turnover and the oral health
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bernhard Gottlieb University clinic of Dentistry

Vienna, Vienna, 1090, Austria

Location

Related Publications (4)

  • 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.

    PMID: 18573992RESULT

  • 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.

    PMID: 12897619RESULT

  • 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.

    PMID: 21939106RESULT

  • 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.

    PMID: 25263143DERIVED

MeSH Terms

Conditions

Mesial Movement of Teeth

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Tooth MigrationPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Hans P Bantleon, Prof, M.D.

    Bernhard Gottlieb University Clinic of Dentistry, Department of Orthodontics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DMD,DMS

Study Record Dates

First Submitted

September 26, 2012

First Posted

September 28, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

October 12, 2015

Record last verified: 2015-10

Locations

AU(1)