Efficacy and Safety of HA35 Gel Nighttime Occlusive Application for TMD Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Gel.
- Who it may be relevant to
- Registry conditions: Temporomandibular Joint Disorders, TMD, Temporomandibular Joint Pain, Jaw Muscle Over-Tension. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective, Single-Arm, Open-Label Pilot Clinical Study to Evaluate Efficacy and Safety of Nighttime Occlusive 10% 35 kDa Hyaluronan (HA35) Gel for Temporomandibular Joint Disorder (TMD) Pain and Muscle Over-Tension
Overview
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.
Detailed description
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.
Interventions
- 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.
Primary outcome measures
- Change in TMJ Pain NRS Score (0-10) [Time frame: Baseline to 60 seconds and 12 hours after application]
Secondary outcome measures (2)
- Change in Jaw Muscle Over-Tension Intensity (0-10 NRS Score) [Time frame: Baseline to 60 seconds and 12 hours after application]
- Incidence and Severity of Local Skin Adverse Events [Time frame: From study enrollment (baseline) to the end of the 12-hour observation period]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07584642 · HA35202605