Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:55 PM
Study NCT ID:
NCT06244134
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2024-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Autologous Blood Injection in Temporomandibular Joint Dislocation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004204', 'term': 'Joint Dislocations'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-02', 'studyFirstSubmitDate': '2024-01-25', 'studyFirstSubmitQcDate': '2024-02-02', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'maximum mouth opening', 'timeFrame': 'at 2weeks, 3months and 6 months post-operative', 'description': "change in Maximum mouth opening (MMO): It's measured (in millimeter) from incisal edge of 11 to 41, in maximum mouth open position using caliper"}], 'secondaryOutcomes': [{'measure': 'Frequency of temporomandibular joint dislocation:', 'timeFrame': '2weeks, 3 months and 6 months post-operatively', 'description': 'number of dislocation per week'}, {'measure': 'change of pain', 'timeFrame': '2weeks, 3 months and 6 months post-operatively', 'description': 'measuring pain using visual analogue scale(0-10),higher scores mean worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ultrasound', 'autologous blood', 'temporomandibular joint', 'dislocation'], 'conditions': ['Temporomandibular Joint Dislocation']}, 'referencesModule': {'references': [{'pmid': '33041574', 'type': 'BACKGROUND', 'citation': 'Gagnani SP, Kholakiya YR, Arora A, Bhutia O, Seith A, Khandelwal RK, Roychoudhury A. Ultrasound-guided autologous blood injection in patients with chronic recurrent temporomandibular joint dislocation. Natl J Maxillofac Surg. 2020 Jan-Jun;11(1):34-39. doi: 10.4103/njms.NJMS_57_18. Epub 2020 Jun 18.'}, {'pmid': '36683930', 'type': 'BACKGROUND', 'citation': 'Pandey SK, Baidya M, Srivastava A, Garg H. Comparison of autologous blood prolotherapy and 25% dextrose prolotherapy for the treatment of chronic recurrent temporomandibular joint dislocation on the basis of clinical parameters: A retrospective study. Natl J Maxillofac Surg. 2022 Sep-Dec;13(3):398-404. doi: 10.4103/njms.njms_509_21. Epub 2022 Dec 10.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is To compare the accuracy and effectiveness of ultrasound (US) guided autologous blood injection (ABI) versus non- guided technique for the treatment of chronic recurrent temporomandibular joint dislocation', 'detailedDescription': "All patients involved in this study will be divided randomly to two different groups and injected with autologous blood into joint space and pericapsular tissue.\n\nStudy group (group A) will be injected with autologous blood with ultrasound guidance.\n\ncontrol group (group B) will be injected with autologous blood without US guidance. Anatomical landmarks and tactical sense will be followed only.\n\nThe operation will be done under local anesthesia ( Auriculotemporal nerve block ) the skin overlying the temporomandibular joint will be scrubbed by an antiseptic solution and the area will be isolated with sterile towels. External auditory canal will be blocked with cotton.\n\nAbout 3 ml of blood will be withdrawn from patient's antecubital fossa, of which 2 ml injected intra-articular and 1 ml in the pericapsular tissue (PT) The procedure should be repeated on the opposite side in case of bilateral involvement."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient with at least 3 episodes of temporomandibular joint dislocation in the past 6 months.\n* Necessitating a visit to the emergency room or trained professional to reduce the dislocation.\n* Radiological evidence of displacement of condylar head beyond the articular eminence on wide mouth opening.\n* Maximum mouth opening (MMO) more than 40 mm.\n* Unilateral or bilateral.\n* Over 18 years of age.\n* Both gender Males or females.\n\nExclusion Criteria:\n\n* Patient having inflammatory temporomandibular joint disease like tuberculous arthritis, rheumatoid arthritis.\n* Patients with bleeding disorders, pregnancy or bony pathology of temporomandibular joint .\n* Allergy to local anesthetic.\n* Severe epilepsy or Parkinson's disease.\n* Patient on anti-depressants or anti-psychotics.\n* Inability to follow-up the patient during the entire follow-up period.\n* Patients who had recent fracture at temporomandibular joint level or who had previous surgical interference to temporomandibular joint .\n* Refused to sign the written informed consent were also excluded.\n* Dystonia"}, 'identificationModule': {'nctId': 'NCT06244134', 'briefTitle': 'Ultrasound Guided Autologous Blood Injection in Temporomandibular Joint Dislocation', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Ultrasound -Guided Versus Conventional Non Guided Autologous Blood Injection For Treatment of Patients With Chronic Recurrent Temporomandibular Joint Dislocation. A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '291123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Study group (group A) will be injected with ultrasound guidance in temporomandibular joint .', 'description': 'uses of ultrasound as a guiding tool for temporomandibular joint injection', 'interventionNames': ['Procedure: ultrasound guided autologous blood injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group(group B) conventional non guided injection in temporomandibular joint', 'description': 'without ultrasound guidance only anatomical landmark will be followed during injection', 'interventionNames': ['Procedure: non guided autologous blood injection']}], 'interventions': [{'name': 'ultrasound guided autologous blood injection', 'type': 'PROCEDURE', 'description': 'guided', 'armGroupLabels': ['Study group (group A) will be injected with ultrasound guidance in temporomandibular joint .']}, {'name': 'non guided autologous blood injection', 'type': 'PROCEDURE', 'description': 'non guided', 'armGroupLabels': ['control group(group B) conventional non guided injection in temporomandibular joint']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Abbas, bachelor', 'role': 'CONTACT', 'email': 'mohamed.abbas@dentistry.cu.edu.eg', 'phone': '01157370918'}], 'facility': 'faculty of dentistry, Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mohamed Abbas, bachelor', 'role': 'CONTACT', 'email': 'mohamed.abbas@dentistry.cu.edu.eg', 'phone': '01157370918'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Mohamed Abbas Morsy Hussien', 'investigatorAffiliation': 'Cairo University'}}}}