Efficacy and Safety of HA35 Gel Nighttime Occlusive Application for TMD Pain (HA35-TMJ)
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
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：HA35 Gel Nighttime Occlusive Application Group
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.
|
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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in TMJ Pain NRS Score (0-10)
大体时间：Baseline to 60 seconds and 12 hours after application
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Change in TMD-related TMJ pain intensity measured by 0-10 NRS, 0 = no pain, 10 = worst imaginable pain.
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Baseline to 60 seconds and 12 hours after application
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Jaw Muscle Over-Tension Intensity (0-10 NRS Score)
大体时间：Baseline to 60 seconds and 12 hours after application
|
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.
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Baseline to 60 seconds and 12 hours after application
|
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Incidence and Severity of Local Skin Adverse Events
大体时间：From study enrollment (baseline) to the end of the 12-hour observation period
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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).
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From study enrollment (baseline) to the end of the 12-hour observation period
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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