An interventional study of 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Gel in Temporomandibular Joint Disorders, TMD and Temporomandibular Joint Pain, sponsored by Nakhia Impex LLC. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Nakhia Impex LLC · Not applicable, Interventional, and Supportive care
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.
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.
591 studies on the registry are indexed under Temporomandibular Joint Disorders; 149 are open to participants now.
This study's enrollment of 30 is below the median of 45 across 415 interventional studies indexed under Temporomandibular Joint Disorders.
Browse Temporomandibular Joint Disorders studies →Nakhia Impex LLC is the lead sponsor of 15 studies on the registry; none are open to participants now.
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A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive 10% high-concentration 35 kDa HA35 gel applied to the TMJ area nightly under occlusive conditions for 8-12 hours. Efficacy on TMJ pain, muscle over-tension, and safety will be evaluated.
Device: 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Gel
Topical gel containing 10% high-concentration 35 kDa hyaluronan fragment. Applied to the TMJ area under nighttime occlusive conditions to rapidly relieve TMD-related pain and muscle over-tension.
Also known as: HA35 TMJ Gel, Nighttime Occlusive HA35 Gel
Change in TMJ Pain NRS Score (0-10)
Change in TMD-related TMJ pain intensity measured by 0-10 NRS, 0 = no pain, 10 = worst imaginable pain.
Time frame: Baseline to 60 seconds and 12 hours after application
Change in Jaw Muscle Over-Tension Intensity (0-10 NRS Score)
Change in jaw muscle over-tension intensity, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no muscle tension and 10 = maximum, painful muscle over-tension.
Time frame: Baseline to 60 seconds and 12 hours after application
Incidence and Severity of Local Skin Adverse Events
Number and severity of treatment-related local skin adverse events (e.g., redness, irritation, allergic reaction) reported during the study. Severity is graded using the Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: From study enrollment (baseline) to the end of the 12-hour observation period
Ran from May 2026 to primary completion in Jul 2026, 2 months.
Of 246 interventional studies with no phase under Temporomandibular Joint Disorders, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 21. This study's 2 months is below that.
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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