Efficacy and Safety of HA35 Gel Nighttime Occlusive Application for TMD Pain

This prospective, single-center, single-arm, open-label pilot clinical study investigates the efficacy and safety of nighttime occlusive topical 10% high-concentration 35 kDa hyaluronan (HA35) gel for relieving pain and muscle over-tension associated with temporomandibular joint disorder (TMD).

Eligible subjects will apply ≥6.5 mL of HA35 gel to the TMJ region before sleep, covered with an occlusive film for 8-12 hours overnight. Pain intensity and muscle over-tension will be assessed using a 0-10 Numeric Rating Scale (NRS) at baseline, 60 seconds after application, and 12 hours after application.

Local skin reactions, adverse events, and overall tolerability will be monitored continuously.

This is a non-invasive, non-pharmacological intervention with minimal risk to participants. All procedures will be conducted in accordance with the Declaration of Helsinki, and written informed consent will be obtained from all subjects prior to enrollment.

Inclusion criteria

• 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
• Ability to complete NRS assessments independently
• Signed written informed consent

Exclusion criteria

• 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)
• Known hypersensitivity to hyaluronan or gel components
• Pregnant or lactating women