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

Study acronym: HA35-TMJ
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Completed without a posted recruiting period Show 4 more changesShow less
    • Primary completion date changed from estimate of Jun 20, 2026 to Jul 20, 2026
    • Study completion date changed from estimate of Jul 20, 2026 to Aug 20, 2026
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 1 of 2 entries
  2. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
(from sponsor)		 Temporomandibular Joint Disorders, TMD, Temporomandibular Joint Pain, Jaw Muscle Over-Tension, Bruxism
Related terms Agnosia, Bruxism, Temporomandibular Joint Disorders
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov