Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-01-04 @ 8:55 AM
Study NCT ID:
NCT01600118
Status:
COMPLETED
Last Update Posted:
2015-10-12
First Post:
2012-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Shock Waves on Dental Parameters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014086', 'term': 'Tooth Mobility'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074059', 'term': 'Extracorporeal Shockwave Therapy'}], 'ancestors': [{'id': 'D014464', 'term': 'Ultrasonic Therapy'}, {'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-09', 'studyFirstSubmitDate': '2012-05-14', 'studyFirstSubmitQcDate': '2012-05-14', 'lastUpdatePostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'periodontal stability of orthodontically aligned teeth', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'pulpal blood flow', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['tooth mobility', 'periodontal status', 'irregularity index', 'pulpal blood flow'], 'conditions': ['Tooth Stability', 'Blood Flow']}, 'referencesModule': {'references': [{'pmid': '18573992', 'type': 'RESULT', '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. doi: 10.1177/154405910808700703.'}, {'pmid': '12897619', 'type': 'RESULT', '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. doi: 10.1097/01.blo.0000073344.50837.cd.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy patients which don´t fulfill the exclusion criteria\n\nExclusion Criteria:\n\n* diseases (syndroms, infections,...) which influence the bone turnover and blood flow\n* medication, which influences the bone turnover and blood flow\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01600118', 'briefTitle': 'Effect of Shock Waves on Dental Parameters', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Effect of Low-energy Extracorporeal Shock Waves on Periodontal and Endodontic Parameters', 'orgStudyIdInfo': {'id': 'ESWT1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ESWT', 'description': 'Extracorporeal shockwave therapy', 'interventionNames': ['Device: Extracorporeal shockwave therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'ESWT Placebo', 'description': 'No extracorporeal shockwave therapy', 'interventionNames': ['Device: No extracorporeal shockwave']}], 'interventions': [{'name': 'Extracorporeal shockwave therapy', 'type': 'DEVICE', 'otherNames': ['Orthogold 100 MTS'], 'description': '1000 impulses', 'armGroupLabels': ['ESWT']}, {'name': 'No extracorporeal shockwave', 'type': 'DEVICE', 'description': '0 impulses, acoustic effect', 'armGroupLabels': ['ESWT Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'Bernhard Gottlieb University clinic of Dentistry', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DMD,DMS', 'investigatorFullName': 'Frank Falkensammer, DMD,DMS', 'investigatorAffiliation': 'Medical University of Vienna'}}}}