[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638786":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":23,"locations":23,"responsibleParty":24,"collaborators":23,"id":26,"slug":27,"hasResults":28,"nctId":29,"briefTitle":30,"officialTitle":31,"acronym":32,"eligibilityCriteria":33,"healthyVolunteers":28,"sex":34,"minAge":35,"maxAge":36,"enrollmentInfo":37,"targetDuration":23,"studyType":40,"phases":41,"briefSummary":43,"conditions":44,"keywords":50,"overallStatus":59,"whyStopped":23,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":23},{"fullName":5,"class":6},"Nakhia Impex LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HA35 Gel Nighttime Occlusive Application Group","EXPERIMENTAL","Participants receive 10% high-concentration 35 kDa HA35 gel applied to the TMJ area nightly under occlusive conditions for 8-12 hours. Efficacy on TMJ pain, muscle over-tension, and safety will be evaluated.",[13],"Device: 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Gel",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Gel","Topical gel containing 10% high-concentration 35 kDa hyaluronan fragment. Applied to the TMJ area under nighttime occlusive conditions to rapidly relieve TMD-related pain and muscle over-tension.",[9],[21,22],"HA35 TMJ Gel","Nighttime Occlusive HA35 Gel",null,{"type":25,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100638786","efficacy-and-safety-of-ha35-gel-nighttime-occlusive-application-for-tmd-pain-100638786",false,"NCT07584642","Efficacy and Safety of HA35 Gel Nighttime Occlusive Application for TMD Pain","A Prospective, Single-Arm, Open-Label Pilot Clinical Study to Evaluate Efficacy and Safety of Nighttime Occlusive 10% 35 kDa Hyaluronan (HA35) Gel for Temporomandibular Joint Disorder (TMD) Pain and Muscle Over-Tension","HA35-TMJ","Inclusion Criteria:\n\n* Age 18-60 years, male or female\n* Clinically diagnosed with TMD with TMJ pain and\u002For muscle over-tension\n* Baseline TMJ pain NRS score ≥3\n* History of bruxism or jaw clenching\n* Ability to complete NRS assessments independently\n* Signed written informed consent\n\nExclusion Criteria:\n\n* TMJ treatment (medication, physical therapy, injection) within 2 weeks\n* Topical analgesic\u002Fanti-inflammatory use within 24 hours\n* Skin damage, allergy, or infection in the TMJ application area\n* Severe systemic disease (cardiovascular, diabetes, autoimmune)\n* Known hypersensitivity to hyaluronan or gel components\n* Pregnant or lactating women","ALL","18 Years","60 Years",{"count":38,"type":39},30,"ESTIMATED","INTERVENTIONAL",[42],"NA","This is a prospective, single-arm, open-label, pilot clinical study to evaluate the efficacy and safety of nighttime occlusive application of 10% high-concentration 35 kDa hyaluronan (HA35) gel in subjects with temporomandibular joint disorder (TMD). Eligible participants will apply HA35 gel to the TMJ area nightly under occlusive conditions for 8-12 hours. The primary objectives are to assess rapid pain relief and muscle over-tension reduction at 60 seconds and 12 hours after application. Safety and local tolerability will be evaluated throughout the study period. This is a minimal-risk, non-pharmacological, non-invasive intervention.",[45,46,47,48,49],"Temporomandibular Joint Disorders","TMD","Temporomandibular Joint Pain","Jaw Muscle Over-Tension","Bruxism",[51,52,53,54,46,47,55,56,57,58],"Hyaluronan","35 kDa Hyaluronan","Nighttime Occlusive","TMJ","Muscle Over-Tension","Analgesia","Non-invasive Treatment","Pilot Clinical Study","NOT_YET_RECRUITING","2026-05-07",{"date":62,"type":63},"2026-05-13","ACTUAL",{"date":65,"type":39},"2026-05-20",{"date":67,"type":39},"2026-07-20",{"name":5,"class":6}]