Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
Study NCT ID:
NCT05548894
Status:
COMPLETED
Last Update Posted:
2022-09-27
First Post:
2022-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Splint and Laser in Patients Without Disc Displacement With Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-23', 'studyFirstSubmitDate': '2022-09-11', 'studyFirstSubmitQcDate': '2022-09-17', 'lastUpdatePostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluation of mouth opening', 'timeFrame': '6 months', 'description': 'improvement in mouth opening or not'}, {'measure': 'Masticatory muscles palpation', 'timeFrame': '6 months', 'description': 'the masticatory muscles were palpated bilaterally with firm and constant pressure of one kg lasted two seconds to define painful areas'}, {'measure': 'temporomandibular joint palpation', 'timeFrame': '6 months', 'description': 'joint pain was achieved by first palpating the temporomandibular joint lateral pole by placing the index finger with firm and constant pressure of half kg lasted\n\ntwo seconds over the condyle in front of the tragus'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['TMJ Disc Disorder']}, 'referencesModule': {'references': [{'pmid': '23835639', 'type': 'BACKGROUND', 'citation': 'Ooi K, Yura S, Inoue N, Totsuka Y. Factors related to the incidence of anterior disc displacement without reduction and bony changes of the temporomandibular joint in patients with anterior open bite. Oral Maxillofac Surg. 2014 Dec;18(4):397-401. doi: 10.1007/s10006-013-0424-3. Epub 2013 Jul 9.'}, {'pmid': '8638492', 'type': 'BACKGROUND', 'citation': 'Samdal F, Amland PF, Sandsmark M, Hall C, Aasen AO. Suction-assisted lipectomy does not increase the risk of random flap necrosis in a randomized study in pigs. Aesthetic Plast Surg. 1995 Nov-Dec;19(6):549-53. doi: 10.1007/BF00454320.'}, {'pmid': '36564950', 'type': 'DERIVED', 'citation': 'El-Shaheed NH, Mostafa AZH, Aboelez MA. Efficacy of stabilisation splint and low-level laser therapy for patients with chronic closed lock from non-reducible displaced temporo-mandibular joint discs: A parallel randomised clinical trial. J Oral Rehabil. 2023 Mar;50(3):177-193. doi: 10.1111/joor.13405. Epub 2023 Jan 5.'}]}, 'descriptionModule': {'briefSummary': 'Stabilization splint therapy and Low-level laser therapy may serve as non-invasive intervention for painful temporomandibular disorders, but its efficacy is still debated. This study compared the effect of stabilization splint and low-level laser therapy alone or in combination in patients with painful chronic closed lock of temporomandibular joints disc displacement without Reduction 42 patients diagnosed with chronic closed lock of disc displacement without reduction were allocated equally and randomly into three treatment groups: group I received combined stabilization splint and low- level laser therapy, group II received low - level laser therapy and group III received stabilization splint. They were evaluated at baseline and one week, two weeks, four weeks, three months, and six months after the intervention.', 'detailedDescription': 'Objectives: Stabilization splint therapy and low- level laser therapy may serve as non-invasive intervention for painful temporomandibular disorders, but its efficacy is still debated. This study compared the effect of stabilization splint and low- level laser therapy alone or in combination in patients with painful chronic closed lock of temporomandibular joints disc displacement without Reduction.\n\nPatients and methods: 42 patients diagnosed with chronic closed lock of disc displacement without reduction were allocated equally and randomly into three treatment groups: group I received combined stabilization splint and low-level laser therapy, group II received low-level laser therapy and group III received stabilization splint. They were evaluated at baseline and one week, two weeks, four weeks, three months, and six months after the intervention. Time of being normal was also evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of chronic closed lock patients\n* Must not be able to open their mouth\n\nExclusion Criteria:\n\n* neurologic diseases\n* TMJ pathologic lesions'}, 'identificationModule': {'nctId': 'NCT05548894', 'briefTitle': 'Comparison Between Splint and Laser in Patients Without Disc Displacement With Reduction', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Comparison Between the Efficacy of Stabilization Splint and Low Level Laser Therapy for Treatment of Patients With Chronic Closed Lock of the Non-reducible Temporo-mandibular Joint Disc. A Parallel Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'A34080622'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'stabilization splint', 'description': 'acrylic splint in the maxillary arch with flat surface', 'interventionNames': ['Device: stabilization splint']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'laser therapy', 'description': 'laser beam directed to the affected part cause activation of blood circulation', 'interventionNames': ['Device: laser therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'stabilization splint and laser therapy', 'description': 'using both laser therapy and stabilization splint for more improvement', 'interventionNames': ['Device: stabilization splint and laser therapy']}], 'interventions': [{'name': 'stabilization splint', 'type': 'DEVICE', 'otherNames': ['upper acrylic full arch splint'], 'description': 'upper acrylic splint rest on the maxillary teeth and had flat surface', 'armGroupLabels': ['stabilization splint']}, {'name': 'laser therapy', 'type': 'DEVICE', 'otherNames': ['Low-level laser therapy'], 'description': 'The laser apparatus had a hand piece on which either a specially designed optic prism was attached to transfer laser energy to the tip of the prism', 'armGroupLabels': ['laser therapy']}, {'name': 'stabilization splint and laser therapy', 'type': 'DEVICE', 'otherNames': ['splint combined with low level laser therapy'], 'description': 'the stabilization splint used in combination of treatment with laser therapy', 'armGroupLabels': ['stabilization splint and laser therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Mansoura university', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Noha Elshahid', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'lecturer at mansoura university prosthodontic department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}