[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649633":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":32,"locations":32,"responsibleParty":33,"collaborators":37,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":32,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":67,"whyStopped":32,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":32},{"fullName":5,"class":6},"Al-Bayan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arthrocentesis","EXPERIMENTAL","Participants will undergo temporomandibular joint arthrocentesis, a minimally invasive joint lavage procedure.",[13],"Procedure: Arthrocentesis",{"label":15,"type":16,"description":17,"interventionNames":18},"Botulinum Toxin Injection","ACTIVE_COMPARATOR","Participants will receive an intramuscular injection of botulinum toxin (Botox) into the masticatory muscles (masseter and temporalis)",[19],"Drug: Botulinum Toxin-A",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Temporomandibular joint (TMJ) arthrocentesis will be performed under local anesthesia using a standard two-needle technique. Two needles will be inserted into the superior joint space, and the joint will be irrigated with sterile isotonic solution (e.g., Ringer's lactate or normal saline, approximately 100-300 mL) to lavage inflammatory mediators and break minor intra-articular adhesions. The procedure will be performed as a single session by a trained oral and maxillofacial surgeon. Patients will be advised to follow a soft diet and may receive standard analgesics as needed following the procedure.",[9],[26],"lavage",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Botulinum Toxin-A","Botulinum toxin type A (Botox) will be injected intramuscularly into the masseter and temporalis muscles bilaterally. Injection sites will be determined by palpation of muscle bulk and activity during voluntary contraction (patients will be asked to clench their teeth to identify the muscle borders and the point of maximal bulk\u002Ftenderness).\n\nThe total dose will be 25-50 units per masseter muscle and 10-25 units per temporalis muscle, administered as a single session.\n\nThe procedure will be performed by a trained physician experienced in botulinum toxin injection technique.\n\nPatients will be monitored for the onset of muscle relaxation effects, expected within days to weeks following injection.",[15],null,{"type":34,"investigatorFullName":35,"investigatorTitle":36,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"SPONSOR_INVESTIGATOR","Mudher MB Alsunbuli","Assistant Professor Dr.",[38],{"name":5,"class":6},"100649633","arthrocentesis-versus-botulinum-toxin-injection-in-patients-with-temporomandibular-joint-disorders-a-randomized-controlled-trial-100649633",false,"NCT07736521","Arthrocentesis Versus Botulinum Toxin Injection in Patients With Temporomandibular Joint Disorders: A Randomized Controlled Trial","RCT","Inclusion Criteria:\n\n* Clinically and radiographically confirmed temporomandibular joint (TMJ) disorder, diagnosed according to Wilkes staging or the Research Diagnostic Criteria for Temporomandibular Disorders (RDC\u002FTMD)\n* Age 18 years or older\n* Symptom duration of at least 3 months\n* Unresponsive to conservative therapy\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Previous TMJ surgery\n* Systemic rheumatic\u002Finflammatory joint disease (e.g., rheumatoid arthritis, ankylosing spondylitis)\n* Bony ankylosis of the TMJ\n* Pregnancy\n* Known allergy or contraindication to botulinum toxin\n* Concurrent use of muscle relaxants, corticosteroids, or anticoagulant medication that may confound treatment effects\n* Unwillingness or inability to attend scheduled follow-up visits","ALL","18 Years","64 Years",{"count":50,"type":51},66,"ESTIMATED","INTERVENTIONAL",[54],"NA","The goal of this clinical trial is to learn if arthrocentesis works as well as botulinum toxin (Botox) injection to treat pain and jaw dysfunction in adults with temporomandibular joint (TMJ) disorders.\n\nThe main questions it aims to answer are:\n\n* Does arthrocentesis reduce pain more, less, or the same as Botox injection?\n* Does arthrocentesis improve jaw opening and function more, less, or the same as Botox injection?\n* What side effects do participants have with each treatment?\n\nResearchers will compare arthrocentesis to Botox injection to see which treatment works better for reducing pain and improving jaw movement in patients with TMJ disorders.\n\nParticipants will:\n\n* Be randomly assigned to receive either arthrocentesis (a joint-washing procedure) or a Botox injection into the jaw muscles\n* Visit the clinic at 1, 3, and 6 months after treatment for checkups and assessments - Rate their pain and have their jaw movement measured at each visit\n* Complete short questionnaires about their jaw function and quality of life",[57,58,59],"Temporomandibular Joint Disorders","Temporomandibular Joint Dysfunction Syndrome","Facial Pain",[57,9,61,62,63,64,65,66],"Botulinum Toxin","TMJ Pain","Randomized Controlled Trial","Botox","Maximum Mouth Opening","Visual Analog Scale","NOT_YET_RECRUITING","2026-07-26",{"date":70,"type":71},"2026-07-30","ACTUAL",{"date":73,"type":51},"2026-08-15",{"date":75,"type":51},"2027-05-01",{"name":35,"class":6}]