Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:14 AM
Study NCT ID:
NCT07463404
Status:
COMPLETED
Last Update Posted:
2026-03-17
First Post:
2026-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Arthrocentesis, Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor in Treatment of Temporo-Mandibular Joint Anterior Displacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study was conducted on adults between the age of 18-40 years old with temporomandibular joint internal derangement (20 cases) requiring arthrocentesis, the patients were divided to 10 cases with anterior disc displacement with reduction and 10 cases with anterior disc displacement without reduction, and the two groups will be injected after arthrocentesis by combination of PRP and Cyclooxygenase Enzyme-2 Inhibitor.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-13', 'studyFirstSubmitDate': '2026-03-05', 'studyFirstSubmitQcDate': '2026-03-05', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mandibular Movements: measured in millimeters using a ruler or digital caliper.', 'timeFrame': 'immediately, one, three and six months postoperatively', 'description': 'Mandibular Movements: Including maximum mouth opening (MMO), right and left lateral movements, and protrusive movement, measured in millimeters using a ruler or digital caliper.'}, {'measure': 'pain assessed by visual analogue scale', 'timeFrame': 'preoperatively, one, three and six months postoperatively', 'description': 'Pain: Assessed using a Visual Analogue Scale ranging from 0 to 10 over the TMJ area \\[ 0 is given when there is no pain, 1-3 mild pain, 4-6 moderate pain, 7-9 severe pain, 10 the worst pain\\].'}, {'measure': 'Joint Clicking: Evaluated using a stethoscope and recorded as either present or absent.', 'timeFrame': 'immediately, one, three, six months postoperatively', 'description': 'Joint Clicking: Evaluated using a stethoscope and recorded as either present or absent.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['temporomandibular joint internal derangement', 'Reducing discomfort', 'restoring normal mandibular motions', "enhancing patients' quality of life"], 'conditions': ['Temporomandibular Joint Internal Derangement']}, 'descriptionModule': {'briefSummary': 'Clinical Evaluation of Arthrocentesis, Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor in Treatment of Temporo-Mandibular Joint Anterior Displacement', 'detailedDescription': "The internal derangement (ID) of the TMJ is an improper functional and positional connection between the articular components of the joint. It has been estimated that 80% of TMD patients have ID, which is typically classified into two classes: disc displacement with reduction and disc displacement without reduction.\n\nThe ID of the TMJ was often accompanied by the increased expression of COX-2 in both synovium and synovial fluid. This allows the accumulation of prostaglandins in synovial fluid, accompanied by peripheral Vaso permeability, that may lead to swollen synovium. Patients may become suffering from limited jaw motion and associated pain around the TMJ in this stage.\n\nArthrocentesis reduces the pain through removing the adherences, eliminates the negative pressure in the joint, washes the inflammatory mediators, distends the joint space, recovering the space of the joint disc and fossa, changes the viscosity of the synovial liquid.\n\nReducing discomfort, restoring normal mandibular motions, and enhancing patients' quality of life are all necessary components of effective treatment for arthrogenous TMDs.\n\nTreatment of TMJ-ID with arthrocentesis, either alone or in conjunction with intraarticular injections, is quite successful. It enhances jaw motions, promotes mouth opening, and lessens discomfort. For intra-articular injections, hyaluronic acid, platelet-rich plasma, corticosteroids and non-steroidal anti-inflammatory medications (NSAIDS) are used."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged from 18 to 40 years old.\n* patients diagnosed with ID of TMJ, suffering from limited mandibular movements, joint pain and clicking.\n* Patients who are free from any systemic disease and controlled systemic disease (ASA I) (ASA II).\n* Patients willing to comply with the follow-up schedule and treatment protocol.\n* both genders are included\n\nExclusion Criteria:\n\n* Patients with systemic diseases (ASA III, IV, V).\n* Patients who have myofascial pain dysfunction syndrome only.\n* Patients who have previous surgery in TMJ.\n* Patients who have previous arthrocentesis within 1 year.\n* Patients who received previous trauma to the joint.\n* Use of anticoagulants or immunosuppressive medications.'}, 'identificationModule': {'nctId': 'NCT07463404', 'briefTitle': 'Clinical Evaluation of Arthrocentesis, Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor in Treatment of Temporo-Mandibular Joint Anterior Displacement', 'organization': {'class': 'OTHER', 'fullName': 'Suez Canal University'}, 'officialTitle': 'Clinical Evaluation of Arthrocentesis, Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor in Treatment of Temporo-Mandibular Joint Anterior Displacement', 'orgStudyIdInfo': {'id': 'Arthrocentesis of TMJ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'patients with anterior disc displacement with reduction', 'description': '10 cases with anterior disc displacement with reduction were injected after arthrocentesis by combination of PRP and meloxicam (Mobitil 15mg).', 'interventionNames': ['Combination Product: Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor after arthrocentesis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'patients with anterior disc displacement without reduction', 'description': '10 cases with anterior disc displacement without reduction were injected after arthrocentesis by combination of PRP and meloxicam (Mobitil 15mg).', 'interventionNames': ['Combination Product: Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor after arthrocentesis']}], 'interventions': [{'name': 'Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor after arthrocentesis', 'type': 'COMBINATION_PRODUCT', 'description': 'Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor meloxicam (Mobitil 15mg) after arthrocentesis', 'armGroupLabels': ['patients with anterior disc displacement with reduction', 'patients with anterior disc displacement without reduction']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ismailia', 'country': 'Egypt', 'facility': 'faculty of dentistry Suez Canal university', 'geoPoint': {'lat': 30.60427, 'lon': 32.27225}}], 'overallOfficials': [{'name': 'hossni elshahat hossni, postgraduate student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Suez Canal University'}, {'name': 'Suez Canal University', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Suez Canal University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'it is secret to patient'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suez Canal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}