Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT06657118
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-06
First Post:
2024-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Versus Conventional Arthrocentesis in Treatment of Temporomandibular Joint Internal Derangement.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized control trial, parallel group, allocation ratio 1:1 Framework equivalence'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-02', 'studyFirstSubmitDate': '2024-10-23', 'studyFirstSubmitQcDate': '2024-10-23', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum mouth opening', 'timeFrame': 'Patients will be evaluated after 2 weeks from operation and every 2 weeks thereafter for the next 3 months.', 'description': 'Maximum mouth opening of the patient will be measured in Millimetre (mm) using a ruler'}, {'measure': 'Joint pain', 'timeFrame': 'Patients will be evaluated after 2 weeks from operation and every 2 weeks thereafter for the next 3 months.', 'description': 'Joint pain: Will be measured by visual analogue scale (VAS) of 10 units according to pre-determined reference values: 0 No pain. 1-2 Faint pain. 3-4 Mild pain 5-6 Moderate pain. 7-8 Severe pain. 9-10 Excruciating pain.'}], 'secondaryOutcomes': [{'measure': 'Operation time', 'timeFrame': 'Once during every procedure', 'description': 'Operation time will be measured using stopwatch and recorded in minutes'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Internal Derangement of the Tempromandibular Joint']}, 'referencesModule': {'references': [{'pmid': '25702588', 'type': 'BACKGROUND', 'citation': 'Dong XY, He S, Zhu L, Dong TY, Pan SS, Tang LJ, Zhu ZF. The diagnostic value of high-resolution ultrasonography for the detection of anterior disc displacement of the temporomandibular joint: a meta-analysis employing the HSROC statistical model. Int J Oral Maxillofac Surg. 2015 Jul;44(7):852-8. doi: 10.1016/j.ijom.2015.01.012. Epub 2015 Feb 20.'}, {'pmid': '35795636', 'type': 'BACKGROUND', 'citation': 'Maranini B, Ciancio G, Mandrioli S, Galie M, Govoni M. The Role of Ultrasound in Temporomandibular Joint Disorders: An Update and Future Perspectives. Front Med (Lausanne). 2022 Jun 20;9:926573. doi: 10.3389/fmed.2022.926573. eCollection 2022.'}, {'pmid': '18223525', 'type': 'BACKGROUND', 'citation': 'Poveda Roda R, Diaz Fernandez JM, Hernandez Bazan S, Jimenez Soriano Y, Margaix M, Sarrion G. A review of temporomandibular joint disease (TMJD). Part II: Clinical and radiological semiology. Morbidity processes. Med Oral Patol Oral Cir Bucal. 2008 Feb 1;13(2):E102-9.'}, {'pmid': '30412740', 'type': 'BACKGROUND', 'citation': 'Champs B, Corre P, Hamel A, Laffite CD, Le Goff B. US-guided temporomandibular joint injection: Validation of an in-plane longitudinal approach. J Stomatol Oral Maxillofac Surg. 2019 Feb;120(1):67-70. doi: 10.1016/j.jormas.2018.10.008. Epub 2018 Nov 6.'}, {'pmid': '30923970', 'type': 'BACKGROUND', 'citation': 'Bhargava D, Thomas S, Pawar P, Jain M, Pathak P. Ultrasound-guided arthrocentesis using single-puncture, double-lumen, single-barrel needle for patients with temporomandibular joint acute closed lock internal derangement. Oral Maxillofac Surg. 2019 Jun;23(2):159-165. doi: 10.1007/s10006-019-00753-6. Epub 2019 Mar 28.'}, {'pmid': '30719601', 'type': 'BACKGROUND', 'citation': 'Azlag Pekince K, Caglayan F, Pekince A. The efficacy and limitations of USI for diagnosing TMJ internal derangements. Oral Radiol. 2020 Jan;36(1):32-39. doi: 10.1007/s11282-019-00376-3. Epub 2019 Feb 4.'}]}, 'descriptionModule': {'briefSummary': 'The use of Ultrasound as a guide in arthrocentesis of tempromandibular joint versus conventional anatomically guided arthrocentesis in treatment of temporomandibular joint internal derangement: A randomized clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients aged 16 to 45 years of age having temporomandibular joint internal derangement.\n* Patients free from any systemic conditions and bone metabolic diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.\n* ASA 1-2 patients with no contraindications for GA\n* Patients who did not respond to conservative treatment.\n\nExclusion Criteria:\n\n* Patient with uncontrolled systemic diseases precluding administration of general anesthesia.\n* Handicaps and special needs patients.\n* Prisoners.'}, 'identificationModule': {'nctId': 'NCT06657118', 'briefTitle': 'Ultrasound Guided Versus Conventional Arthrocentesis in Treatment of Temporomandibular Joint Internal Derangement.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Ultrasound Guided Versus Conventional Arthrocentesis in Treatment of Temporomandibular Joint Internal Derangement: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'US guided arthrocentesis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional arthrocentesis', 'description': "* Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub.\n* Head turned to the affected side.\n* External auditory meatus will be blocked with a cotton plug.\n* A line will be drawn from tragus of the ear to the outer canthus of the eye with ink.\n* Double needled canula is inserted into superior compartment of the joint space 2mm below and 10 mm ahead of mid-tragal end of Holmund Hellsing's line.\n\nIntra-operative procedures - continued in both groups:\n\n* Lavage is performed with 100 ml of saline solution.\n* 1 ml of Hyaluronic acid is injected into the superior joint space.\n* Puncture point is covered with sterile dressing for 24 hours", 'interventionNames': ['Procedure: Conventional anatomically guided arthrocentesis of tempromandibular joint']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound guided arthrocentesis', 'description': 'Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub.\n\n* Head turned to the affected side.\n* External auditory meatus will be blocked with a cotton plug.\n* Transducer is placed over TMJ, parallel to the long axis of mandibular ramus. • Transducer is tilted until the optimal visualization is obtained.\n* Disc is visualized as a thin homogenous, hypo-to-iso-echoic band lying adjacent to the inferior relation. The bony landmarks of the mandibular condyle and the articular eminence are visualized as hyperdense lines.\n* Superior joint space located between the disc and articular eminence is the targeted point of the needle.\n\nIntra-operative procedures - continued in both groups:\n\n* Lavage is performed with 100 ml of saline solution.\n* 1 ml of Hyaluronic acid is injected into the superior joint space.\n* Puncture point is covered with sterile dressing for 24 hours', 'interventionNames': ['Procedure: Ultrasound guided arthrocentesis of tempromandibular joint']}], 'interventions': [{'name': 'Ultrasound guided arthrocentesis of tempromandibular joint', 'type': 'PROCEDURE', 'description': '* Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub.\n* Head turned to the affected side. • External auditory meatus will be blocked with a cotton plug.\n* Transducer is placed over TMJ, parallel to the long axis of mandibular ramus. • Transducer is tilted until the optimal visualization is obtained.\n* Disc is visualized as a thin homogenous, hypo-to-iso-echoic band lying adjacent to the inferior relation. The bony landmarks of the mandibular condyle and the articular eminence are visualized as hyperdense lines.\n* Superior joint space located between the disc and articular eminence is the targeted point of the needle.\n\nIntra-operative procedures - continued in both groups:\n\n* Lavage is performed with 100 ml of saline solution.\n* 1 ml of Hyaluronic acid is injected into the superior joint space.\n* Puncture point is covered with sterile dressing for 24 hours', 'armGroupLabels': ['Ultrasound guided arthrocentesis']}, {'name': 'Conventional anatomically guided arthrocentesis of tempromandibular joint', 'type': 'PROCEDURE', 'description': "* Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub.\n* Head turned to the affected side. • External auditory meatus will be blocked with a cotton plug.\n* A line will be drawn from tragus of the ear to the outer canthus of the eye with ink.\n* Double needled canula is inserted into superior compartment of the joint space 2mm below and 10 mm ahead of mid-tragal end of Holmund Hellsing's line.\n\nIntra-operative procedures - continued in both groups:\n\n* Lavage is performed with 100 ml of saline solution.\n* 1 ml of Hyaluronic acid is injected into the superior joint space.\n* Puncture point is covered with sterile dressing for 24 hours", 'armGroupLabels': ['Conventional arthrocentesis']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Samiha Abdelsalam Abdelaziz', 'role': 'CONTACT', 'email': 'samiha.abdelaziz@dentistry.cu.edu.eg', 'phone': '+201100791990'}, {'name': 'Moataz Bahaa, Lecturer', 'role': 'CONTACT', 'email': 'moataz.bahaa@bue.edu.eg', 'phone': '+201005609359'}], 'overallOfficials': [{'name': 'Gamal Moutaed, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'share it with other researchers websites if it is possible'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samiha Abdelsalam Abdelaziz Abdelaziz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Samiha Abdelsalam Abdelaziz Abdelaziz', 'investigatorAffiliation': 'Cairo University'}}}}