Effect of Shock Waves on Dental Parameters

Blood Flow Clinical Trial

Official title:

Effect of Low-energy Extracorporeal Shock Waves on Periodontal and Endodontic Parameters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01600118
• Other study ID #: ESWT1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 14, 2012
• Last updated: October 9, 2015
• Start date: September 2011
• Est. completion date: December 2013

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

This randomized clinical trial investigates the effect of the extracorporeal shockwave therapy (ESWT) on periodontal and endodontical parameters. The ESWT is a scientifically approved non invasive method to influence bone turnover and tissue regeneration. The hypotheses of this trial are that ESWT increases the periodontal stability of orthodontically aligned teeth as well as increase the blood flow. Increasing the periodontal stability would reduce the retention phase, relapse risk and accelerate the rehabilitation of the surrounding tissues.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2013
• Est. primary completion date: October 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:

• diseases (syndroms, infections,...) which influence the bone turnover and blood flow

• medication, which influences the bone turnover and blood flow

• 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

• Blood Flow
• Tooth Stability

Intervention

Device:
• Extracorporeal shockwave therapy
1000 impulses
• No extracorporeal shockwave
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 (2)

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
Primary	periodontal stability of orthodontically aligned teeth		6 months	Yes
Secondary	pulpal blood flow		6 months	Yes