CTRI/2024/06/068846已完成不适用
Comparative Evaluation of efficacy of Therapeutic Ultrasound, TENS and LLLT in management of TMJ pain in patients following Restorative procedure: A Randomized Clinical Study
Aishwarya Jain1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月15日最近更新:
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
- 1
- 主要终点
- To evaluate and compare efficacy of Therapeutic Ultrasound, TENS and LLLT in management of TMJ pain in patients following Restorative procedure immediately after therapy, after 6 hours, after 24 hours and after 48 hours.
研究概览
简要总结
-
- Patients with post-restorative procedures will be further assessed for evaluation of pain after removal of rubber dam using VAS. Patient with VAS scale of > 3 will be further subjected for the therapy. In Therapeutic ultrasound group patients, will be given therapy at 1MHz frequency, with a transuder head of 5cm and an effective radiating area of 5cm2 + 20%, placing the probe in TMJ region for 10-15 minutes each side depending on the threshold of the patient. In TENS group, Ultracare-Pro TENS 2.0 unit will be placed at the level of TMJ at a setting of 2-200 Hz frequency, 15 minutes session on each side at 1-10 mode and therapy will be given depending on the threshold of the patients. Patient will be explained about VAS scale, and the pre-treatment VAS scale readings will be recorded. 
In LLLT group, therapy will be performed using 940nm wavelength diode laser (Epic 10. Biolase). The application will be done by the principal investigator at the TMJ musculature region with the laser set at ‘pain therapy’ mode and activated at 4.0 W for 10-15 minutes at each side depending on the heat threshold of patient. The co-investigator will then assess the pain, immediately after the therapy using VAS (1-10 point) scale. Later the pain will be assessed by the co- investigator immediately after therapy, at 6 hours, at 24 hours and at 48 hours. If pain still persists, then analgesics will be given and patient will be excluded from the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having a TMJ pain of VAS more than 3 on 1 to 10 point scale on mouth opening following the restorative treatment will be included in the study.
- •Patients requiring the placement of rubber dam for restorative treatment will be included in the study.
- •A written informed consent will be taken from all the patients and only those patients ready to sign the consent form will be included in the study.
排除标准
- •Patients with myocardial disorders having pacemakers, recent trauma and epileptic patients will be excluded from the study
- •Patients with pulpal exposure will be excluded for the study.
- •Patients with TMD pain prior to the treatment will be excluded from the study
- •Patients who had taken analgesic medication 12 hrs before the treatment will be excluded from the study 5.Pregnant and lactating women will be excluded.
- •6.Medically compromised patients and patients with history to any substance abuse will be excluded from the study.
结局指标
主要结局
To evaluate and compare efficacy of Therapeutic Ultrasound, TENS and LLLT in management of TMJ pain in patients following Restorative procedure immediately after therapy, after 6 hours, after 24 hours and after 48 hours.
时间窗: immediately after therapy, after 6 hours, after 24 hours and after 48 hours.
次要结局
- will tell us about which technique is better for TMJ pain management(immediately after therapy, after 6 hours, after 24 hours and after 48 hours.)
研究者
Aishwarya Jain
KM Shah Dental College and Hospital
研究点 (1)
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