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)
Single group
10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Gel
DeviceTopical 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.
Change in TMJ Pain NRS Score (0-10)
Change in TMD-related TMJ pain intensity measured by 0-10 NRS, 0 = no pain, 10 = worst imaginable pain.
Change in Jaw Muscle Over-Tension Intensity (0-10 NRS Score)
Change in jaw muscle over-tension intensity, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no muscle tension and 10 = maximum, painful muscle over-tension.
Incidence and Severity of Local Skin Adverse Events
Number and severity of treatment-related local skin adverse events (e.g., redness, irritation, allergic reaction) reported during the study. Severity is graded using the Common Terminology Criteria for Adverse Events (CTCAE).
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