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.
Age 18-60 years, male or female
Clinically diagnosed with TMD with TMJ pain and/or muscle over-tension
Baseline TMJ pain NRS score ≥3
History of bruxism or jaw clenching
TMJ treatment (medication, physical therapy, injection) within 2 weeks
Topical analgesic/anti-inflammatory use within 24 hours
Skin damage, allergy, or infection in the TMJ application area
Severe systemic disease (cardiovascular, diabetes, autoimmune)
Nakhia Impex LLC
Lead sponsor