NCT06375330已完成不适用
Clinical Efficacy of Polynucleotides TMJ Injections Compared to Physiotherapy. A 3-months Randomized Clinical Trial.
Sidoti & Tartaglia Srl2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年4月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Maximum mouth opening
研究概览
简要总结
The main objective of the present study is the evaluation of the clinical efficacy of the intra-articular administration of polynucleotides in association with hyaluronic acid in the improvement of the subjective and objective manifestations of arthrosis of the temporomandibular joint compared to normal clinical management which involves Physiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who signed the informed consent
- •age >18;
- •male and female sex;
- •affected by temporomandibular arthrosis
排除标准
- •Patients treated with painkillers and anti-inflammatories;
- •patients suffering from rheumatoid arthritis with TMJ involvement;
- •patients with a positive history of allergies to products of fish origin;
- •patients suffering from alteration of the internal TMJ;
- •patients suffering from mandibular condylar hyperplasia;
- •patients suffering from myofascial pain syndrome;
- •patients unable to express their consent for participation in the study;
- •patients suffering from psychiatric and behavioral disorders;
- •patients suffering from oncological and onco-haematological pathologies with compromised general clinical status.
结局指标
主要结局
Maximum mouth opening
时间窗: 3 months
The primary objective is to evaluate the improvement of symptoms over time in terms of maximum mouth opening of patients (which in most cases is limited) treated with polynucleotides in association with hyaluronic acid compared to patients treated with physiotherapy exercises.
次要结局
- Lateral movements improvements(3 months)
- Pain assessment(3 months)
研究者
Gianluca Tartaglia
Principal Investigator
Sidoti & Tartaglia Srl
研究点 (2)
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