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临床试验/CTRI/2025/08/093730
CTRI/2025/08/093730尚未招募不适用

Comparison of efficacy of photobiomodulation therapy with ibuprofen in reducing pain perception associated with placement of elastomeric separator during initial orthodontic treatment

Dr. Ayasmita Nag1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年9月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
pain reduction by photobiomodulation as compared to ibuprofen

研究概览

简要总结

Orthodontic treatment-induced pain poses challenges, affecting patient compliance. Orthodontic forces trigger pain due to tooth movement and bone remodelling around roots, often managed with Non steroidal antiinflammatory drugs(NSAIDS). However, NSAIDs hinder tooth movement and entail systemic side effects like gastrointestinal problem, hepatotoxicity, hypertension, nephrotoxicity, increased risk of heart disease. Photobiomodulation therapy (PBMT), a non-pharmaceutical alternative, shows promise in reducing pain without systemic effects. Previous studies support PBMT’s effectiveness, making it a potential solution for discomfort after separator placement during orthodontic treatment, offering advantages over traditional NSAIDs. This study assesses photobiomodulation therapy’s efficacy for pain relief after separator placement, comparing its effectiveness to Ibuprofen in initial orthodontic treatment stages. This research has a split-mouth design. Elastomeric separators are applied to first molars in one quadrant, followed by immediate photobiomodulation therapy using a diode laser. Pain perception is recorded at various intervals using the Visual Analogue Scale (VAS). After seven days, the same process is repeated in the contralateral quadrant, but with a placebo therapy and prescribed Ibuprofen. Postoperative pain is assessed using VAS, and the data collected will be compared and analyzed to test hypotheses. The study aims to evaluate the effectiveness of photobiomodulation therapy in managing orthodontic pain compared to a placebo and pain relief medication. It is expected that both the therapies, i.e. photobiomodulation and Ibuprofen will reduce pain and the reduction of pain perception in both of the treatment modalities will vary.

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 Blinded

入排标准

年龄范围
14.00 Year(s) 至 24.00 Year(s)(—)
性别
All

入选标准

  • Patients requiring orthodontic banding with sound first permanent molars having proper proximal contact and permanent second molars should be completely erupted.

排除标准

  • Patients with acute or gastritis, gastroenteritis , gastric ulcers, or suffering from any local or systemic condition that could affect pain perception and presence of posterior crossbite or open bite.

结局指标

主要结局

pain reduction by photobiomodulation as compared to ibuprofen

时间窗: 7 days

次要结局

未报告次要终点

研究者

发起方
Dr. Ayasmita Nag
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Ayasmita Nag

Guru Nanak Institute of Dental Sciences and Research

研究点 (1)

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