Effect of Shock Waves on Tooth Movement and Miniscrew Stability

Mesial Movement of Teeth Clinical Trial

Official title:

Effect of Low-energy Extracorporeal Shock Waves on Orthodontic Tooth Movement and Miniscrew Stability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695928
• Other study ID #: ESWT2
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 26, 2012
• Last updated: October 9, 2015
• Start date: September 2012
• Est. completion date: January 2014

Study information

• Verified date: October 2015
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mesial Movement of Teeth
• Miniscrew Stability

Intervention

Device:
• Extracorporeal shockwave therapy
1000 impulses
• ESWT placebo
0 impulses, acoustic effect

Locations

Country	Name	City	State
Austria	Bernhard Gottlieb University clinic of Dentistry	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (3)

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. Heb — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Periodontal status		4 months	Yes
Primary	Orthodontic tooth movement		4 months	Yes
Secondary	Miniscrew stability		4 months	Yes