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

NCT07584642 | Not Yet Recruiting

• 1 other identifier: HA35202605
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Temporomandibular Joint Disorders; TMD; Temporomandibular Joint Pain; Jaw Muscle Over-Tension; Bruxism

Keywords

Hyaluronan; 35 kDa Hyaluronan; Nighttime Occlusive; TMJ; TMD; Temporomandibular Joint Pain; Muscle Over-Tension; Analgesia; Non-invasive Treatment; Pilot Clinical Study

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 60 seconds and 12 hours after application

Secondary Outcomes (2)

• Change in Jaw Muscle Over-Tension Intensity (0-10 NRS Score)

  Baseline to 60 seconds and 12 hours after application

• Incidence and Severity of Local Skin Adverse Events

  From study enrollment (baseline) to the end of the 12-hour observation period

Study Arms (1)

HA35 Gel Nighttime Occlusive Application Group

EXPERIMENTAL

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

Interventions

10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Gel DEVICE

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

HA35 Gel Nighttime Occlusive Application Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Nakhia Impex LLC: lead

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Bruxism; Agnosia

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Tooth Diseases; Habits; Behavior; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 13, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): July 20, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-04