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

Starting soon · Not applicable

Conditions studied: Temporomandibular Joint Disorders, TMD, Temporomandibular Joint Pain, Jaw Muscle Over-Tension, Bruxism

In brief

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.

Key facts

Study ID

NCT07584642

Run by

Nakhia Impex LLC

People needed

30

Starts

2026-05-20

Expected to finish

2026-07-20

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Full record on ClinicalTrials.gov

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