Effect of Shock Waves on Dental Parameters
Effect of Low-energy Extracorporeal Shock Waves on Periodontal and Endodontic Parameters
1 other identifier
interventional
72
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 14, 2012
CompletedFirst Posted
Study publicly available on registry
May 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedOctober 12, 2015
October 1, 2015
2.1 years
May 14, 2012
October 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
periodontal stability of orthodontically aligned teeth
6 months
Secondary Outcomes (1)
pulpal blood flow
6 months
Study Arms (2)
ESWT
ACTIVE COMPARATORExtracorporeal shockwave therapy
ESWT Placebo
PLACEBO COMPARATORNo extracorporeal shockwave therapy
Interventions
Eligibility Criteria
You may not qualify if:
- diseases (syndroms, infections,...) which influence the bone turnover and blood flow
- medication, which influences the bone turnover and blood flow
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bernhard Gottlieb University clinic of Dentistry
Vienna, Vienna, 1090, Austria
Related Publications (2)
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: 18573992RESULTMartini 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
May 14, 2012
First Posted
May 16, 2012
Study Start
September 1, 2011
Primary Completion
October 1, 2013
Study Completion
December 1, 2013
Last Updated
October 12, 2015
Record last verified: 2015-10