Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT06694532
Status:
RECRUITING
Last Update Posted:
2024-11-19
First Post:
2023-10-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EffIcacy Between Arthrocentesis With High Versus Low Molecular Weight Hyaluronic Acid in Treatment of TMJ Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}], 'ancestors': [{'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006820', 'term': 'Hyaluronic Acid'}, {'id': 'D000069237', 'term': 'Arthrocentesis'}, {'id': 'D013594', 'term': 'Syringes'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'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'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'The study will be carried out in Patients in two Groups aged between 17 to 70 years , of both sexes, who had painful symptoms, with or without presence of joint noise, and had unilateral or bilateral internal derangement of the TMJ proven by clinical examination, with no improvement after conservative treatment, were included in the study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-15', 'studyFirstSubmitDate': '2023-10-30', 'studyFirstSubmitQcDate': '2024-11-15', 'lastUpdatePostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EFFICACY between injection of high versus low molecular weight hyaluronic acid in TMJ arthrocentesis', 'timeFrame': '36 months', 'description': 'The MEASUREMENT TOOL of the study will be carried out by 2 groups the first will be injected by high molecular weight hyaluronic acid and the second wil be injected by low molecular weight hyaluronic acid Then compare between Efectevness of injection of high-molecular weight versus Low moecular weight hyaluronic acid after two-needle arthrocentesis in improving the signs and symptoms of intra-articular TMJ disorder.\n\n, 1- significantly improving the pain on scale 1-10 , and'}], 'secondaryOutcomes': [{'measure': 'comparative between injection of high versus low molecular weight hyaluronic acid in TMJ arthrocentesis', 'timeFrame': '36 months', 'description': 'The MEASUREMENT TOOL of the study will be carried out by 2 groups the first will be injected by high molecular weight hyaluronic acid and the second wil be injected by low molecular weight hyaluronic acid Then compare between Efectevness of injection of high-molecular weight versus Low moecular weight hyaluronic acid after two-needle arthrocentesis in improving the signs and symptoms of intra-articular TMJ disorder.\n\n2-significant improvements in mouth opening range in mm by the distance between the edges of the frontal incisors with a ruler or caliper and joint noise.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Temporomandibular Joint Disorders', 'Arthrocentesis']}, 'descriptionModule': {'briefSummary': 'The study will be carried out in Patients in two Groups aged between 17 to 70 years , of both sexes, who had painful symptoms, with or without presence of joint noise, and had unilateral or bilateral internal derangement of the TMJ proven by clinical examination, with no improvement after conservative treatment.', 'detailedDescription': 'The MEASUREMENT TOOL of the study will be carried out by 2 groups the first will be injected by high molecular weight hyaluronic acid and the second wil be injected by low molecular weight hyaluronic acid Then compare between Efectevness of injection of high-molecular weight versus Low moecular weight hyaluronic acid after two-needle arthrocentesis in improving the signs and symptoms of intra-articular TMJ disorder.\n\n, 1- significantly improving the pain on scale 1-10 , and 2-significant improvements in mouth opening range in mm by the distance between the edges of the frontal incisors with a ruler or caliper and joint noise.\n\n3-The presence of absence of clicking and cracking in jaw .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pain or tenderness of the jaw\n* Pain in one or both of the temporomandibular joints\n* Aching pain in and around your ear\n* Difficulty chewing or pain while chewing\n* Aching facial pain\n* Locking of the joint,\n\nExclusion Criteria:\n\n* Muscular TMJ disorders\n* Bleeding tendency'}, 'identificationModule': {'nctId': 'NCT06694532', 'briefTitle': 'EffIcacy Between Arthrocentesis With High Versus Low Molecular Weight Hyaluronic Acid in Treatment of TMJ Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparative Study Between the Effectiveness of High Versus Low Molecular Weight Hyaluronic Acid in TMJ Arthrocentesis', 'orgStudyIdInfo': {'id': 'Hyaluronic and TMJ Disorders'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'high molucular weight hyalurinic acid .', 'description': 'patients injected e high molucular weight hyalurinic acid .', 'interventionNames': ['Drug: Hyaluronic acid', 'Device: Syringes']}, {'type': 'EXPERIMENTAL', 'label': 'low molcular weight hyaurinic acid', 'description': 'patients injected with low molucular weight hyalurinic acid .', 'interventionNames': ['Drug: Hyaluronic acid', 'Device: Syringes']}], 'interventions': [{'name': 'Hyaluronic acid', 'type': 'DRUG', 'otherNames': ['Arthrocentesis'], 'description': 'Comparative study between Hyalgan and Hyorth injectable products in TMJ Disorders by arthrocentesis of 2 syringes device', 'armGroupLabels': ['high molucular weight hyalurinic acid .', 'low molcular weight hyaurinic acid']}, {'name': 'Syringes', 'type': 'DEVICE', 'otherNames': ['Arthrocentesis'], 'description': 'Whilst you are asleep, two small needles will be inserted into the TMJ / Jaw Joint. One of these needles allows sterile saline to be pumped into the joint under pressure whilst the other needle allows the saline to drain out of the joint then injection of the HA injectiable products .', 'armGroupLabels': ['high molucular weight hyalurinic acid .', 'low molcular weight hyaurinic acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12346', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Basel K Mohamed', 'role': 'CONTACT'}], 'facility': 'Assiut Univeristy', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Basel K Mohamed', 'role': 'CONTACT', 'email': 'Basel_shrider@yahoo.com', 'phone': '+201099848089'}, {'name': 'Basel K Mohamed', 'role': 'CONTACT', 'phone': '+201099848089'}], 'overallOfficials': [{'name': 'Basel K Mohamed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut Univeristy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Basel khaled mohamed', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Basel khaled mohamed', 'investigatorAffiliation': 'Assiut University'}}}}