Effect Of Low-level Laser Therapy On Reducing Orthodontic Pain – A Split-mouth Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- To evaluate the effect of Low-Level Laser Therapy in reducing the pain on separator placement in Maxillary 1st Molars.
研究概览
简要总结
The study will involve randomly selecting patients aged 18-24 who meet the inclusion criteria. Double blinding will be used, where both the statistician and patient will be unaware of the procedures. After obtaining informed consent, patient-specific inclusion criteria will be recorded, and the intervention side will be assigned using a draw method with allocation concealment. Patients will receive posterior elastomeric separators on their maxillary first molars, and LLLT will be applied on the treatment side using a Biolase EpicX Diode Laser. A placebo treatment will be given on the other molar with the same procedure, but no laser emission. Both the laser and placebo treatments will occur at the same time, with patients blinded to the treatment assignment. Pain levels will be assessed using a Visual Analogue Scale (VAS) at various time points after both treatments, with follow-up on days 1 and 3 after separator placement. The evaluation includes pain measurements at multiple intervals (12, 24, 36, 48, 60, 72, 84, 96 hours post-treatment).
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 24.00 Year(s)（—）
- 性别
- All
入选标准
- •Good oral hygiene
- •No systemic or periodontal diseases
- •No intake of medications that interfere with pain perception for at least one week before the beginning of the treatment and also during the course of study
- •Intact maxillary first molars and the presence of healthy contact points of the maxillary first molars with adjacent teetH.
排除标准
- •The intake of NSAIDs or analgesics during the study.
- •Failing to complete the questionnaire 3.
结局指标
主要结局
To evaluate the effect of Low-Level Laser Therapy in reducing the pain on separator placement in Maxillary 1st Molars.
时间窗: The timepoints to measure the outcome will be every 12hrs till 4th day from the time of Low Level Laser Therapy Application. (0hrs, 12hrs, 24hrs,36hrs, 48hrs, 60hrs, 72hrs, 96hrs)
次要结局
- To evaluate the effect of 2 application of low-level laser with 2-4 Joule energy at 940nm wavelength on pain reduction following elastomeric separator placement.(72 weeks)
研究者
Dr Adarsh Ninan Sam
Manipal College of Dental Sciences, Manipal