Temporomandibular Joint DisordersHA35-TMJNCT07584642
Efficacy and Safety of HA35 Gel Nighttime Occlusive Application for TMD Pain
A study testing 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Gel in people with Temporomandibular Joint Disorders and TMD, run by Nakhia Impex LLC at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Temporomandibular Joint Disorders, TMD, Temporomandibular Joint Pain
- What is being tested?
- 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2026to 20 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Temporomandibular Joint Disorders, TMD, Temporomandibular Joint Pain, Jaw Muscle Over-Tension, Bruxism
- Being tested
- 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Gel
- Keywords
- Hyaluronan, 35 kDa Hyaluronan, Nighttime Occlusive, TMJ, TMD, Temporomandibular Joint Pain, Muscle Over-Tension, Analgesia, Non-invasive Treatment, Pilot Clinical Study
- Medical subject headings
- Temporomandibular Joint Disorders, Bruxism, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% High-Concentration 35 kDa Hyaluronan (HA35) Topical GelDevice
Also called HA35 TMJ Gel, Nighttime Occlusive HA35 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 60 seconds and 12 hours after application
Secondary outcomes (2)
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.
Measured: 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).
Measured: From study enrollment (baseline) to the end of the 12-hour observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start20 May 2026
- Primary completion20 Jul 2026
- Study completion20 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nakhia Impex LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584642
- Sponsor's protocol ID
- HA35202605
- Acronym
- HA35-TMJ
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07584642
- Acronym / sponsor ID
- HA35-TMJ / HA35202605
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nakhia Impex LLCIndustry (pharma, biotech, devices)
- Study start
- 20 May 2026 (actual)
- Primary completion
- 20 Jul 2026 (actual)
- Study completion
- 20 Aug 2026 (actual)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HA35 Gel Nighttime Occlusive Application Group | Experimental | Device: 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical GelParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical GelAlso: HA35 TMJ Gel, Nighttime Occlusive HA35 GelTopical 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. | Device | HA35 Gel Nighttime Occlusive Application Group |
Primary outcome
Change in TMJ Pain NRS Score (0-10)
Time frame: Baseline to 60 seconds and 12 hours after application
Change in TMD-related TMJ pain intensity measured by 0-10 NRS, 0 = no pain, 10 = worst imaginable pain.
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Gel in people with Temporomandibular Joint Disorders and TMD, run by Nakhia Impex LLC at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in TMJ Pain NRS Score (0-10) (time frame: Baseline to 60 seconds and 12 hours after application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.