Clinical Trial

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

Study acronym: HA35-TMJ
Not Yet Recruiting
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Record status
This record was last updated May 13, 2026 (before its estimated June 20, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Trial Details
NCT Number NCT07584642
Lead Sponsor Nakhia Impex LLC
Conditions Temporomandibular Joint Disorders, TMD, Temporomandibular Joint Pain, Jaw Muscle Over-Tension, Bruxism
Enrollment 30 participants
Start Date 2026-05-20
Primary Completion 2026-06-20 (estimated)
Study Completion 2026-07-20 (estimated)
Updated on ClinicalTrials.gov 2026-05-13