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Clinical Trial

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

NCT: NCT07584642 · COMPLETED

NCT IDNCT07584642
StatusCOMPLETED
Start Date2026-05-20
Completion2026-08-20
SponsorNakhia Impex LLC (INDUSTRY)
First posted
Last updated

Brief 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.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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