Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-02-20 @ 10:42 PM
Study NCT ID:
NCT01903512
Status:
COMPLETED
Last Update Posted:
2013-07-19
First Post:
2013-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arthrocentesis and Temporomandibular Joint Disorders a Conservative Alternative to Surgical Treatments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069237', 'term': 'Arthrocentesis'}], 'ancestors': [{'id': 'D019152', 'term': 'Paracentesis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-16', 'studyFirstSubmitDate': '2013-07-03', 'studyFirstSubmitQcDate': '2013-07-16', 'lastUpdatePostDateStruct': {'date': '2013-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain decrease', 'timeFrame': 'baseline (preop), 1 week, 1 month, 2 months, 6 months, 12 months (postop)', 'description': 'Patients were followed up for 1 year. The mean pre-operative pain, using visual analog scale, showed an average decrease of 6.7 at 1 year.'}, {'measure': 'increase in the mouth opening', 'timeFrame': 'Baseline (preop), 1 week, 1 month, 2 months, 6 months, 12 months (postop)', 'description': 'The mean maximum mouth opening(MMO) pre-operatively was 15,8 mm and increased to 34 mm immediately following arthrocentesis which increased by 0.5-1 mm at every month followup with mean MMO of 39,4 mm at 6 months. Thereafter it remained consistent till 1 year. The mean increase in the mouth opening at 1 year was 23,6 mm'}, {'measure': 'TMJ click and noises reduction', 'timeFrame': 'Baseline (preop), 12 months (postop)', 'description': 'At the end of 1 year, (75%) patients stated no evidence of clicking.'}], 'secondaryOutcomes': [{'measure': 'number of subjects showing signs of TMJ inflammation or structural alterations at Magnetic Resonance Imaging and Cone Beam Computerized Tomography pre- and postop.', 'timeFrame': 'Baseline (preop)- 60 days postop', 'description': '40% of subjects who showed clear signs of inflammation showed significant improvement, in 30% with structural alterations was evident the absence of intra-articular adhesions and debris, in 30% with internal derangement did not appear any radiographic change.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['TMJ arthrocentesis', 'internal derangement', 'conservative treatment'], 'conditions': ['TMJ Internal Derangement']}, 'referencesModule': {'references': [{'pmid': '24319462', 'type': 'DERIVED', 'citation': 'De Riu G, Stimolo M, Meloni SM, Soma D, Pisano M, Sembronio S, Tullio A. Arthrocentesis and temporomandibular joint disorders: clinical and radiological results of a prospective study. Int J Dent. 2013;2013:790648. doi: 10.1155/2013/790648. Epub 2013 Nov 11.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the efficacy of arthrocentesis in the treatment of internal derangement of the temporomandibular joint (TMJ).', 'detailedDescription': 'This work was designed as a prospective case series clinical study. Patients imaging was evaluated with Cone-Beam Computed Tomography and Nuclear Magnetic Resonance at the beginning of the treatment and after the last arthrocentesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '62 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 30 patients with TMJ internal derangement and pain with history of failed conservative management were selected. 70% had anteriorly displaced discs (AD), and 30 complained of other disorders (osteophytes, signs of soft tissues inflammmation, TMJ structure alterations).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* TMJ pain\n* TMJ noises and click\n* history of unsuccessful conservative management (NSAID and occlusal bite)\n* occlusal bite still present\n\nExclusion Criteria:\n\n* degenerative joint disease (such as osteoarthritis, rheumatoid arthritis etc.)\n* history of condylar fractures or previous TMJ trauma\n* TMJ surgery'}, 'identificationModule': {'nctId': 'NCT01903512', 'briefTitle': 'Arthrocentesis and Temporomandibular Joint Disorders a Conservative Alternative to Surgical Treatments', 'organization': {'class': 'OTHER', 'fullName': 'Università degli Studi di Sassari'}, 'orgStudyIdInfo': {'id': 'IT010713'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'arthrocentesis in TMJ internal derangement', 'description': '30 patients with TMJ internal derangement and pain with history of failed conservative management.', 'interventionNames': ['Procedure: TMJ arthrocentesis']}], 'interventions': [{'name': 'TMJ arthrocentesis', 'type': 'PROCEDURE', 'description': 'lavage of the superior TMJ space with saline and sodium hyaluronate (SH)', 'armGroupLabels': ['arthrocentesis in TMJ internal derangement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07100', 'city': 'Sassari', 'state': 'SS,', 'country': 'Italy', 'facility': 'Maxillofacial Unit, University of Sassari', 'geoPoint': {'lat': 40.72586, 'lon': 8.55552}}], 'overallOfficials': [{'name': 'Silvio M Meloni, assist prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Università degli Studi di Sassari'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università degli Studi di Sassari', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS, PhD, Assistant Professor', 'investigatorFullName': 'Silvio Mario Meloni', 'investigatorAffiliation': 'Università degli Studi di Sassari'}}}}