Evaluation of Low Level Laser Therapy (LLLT) Effect on Pain Management Caused by Orthodontic Elastomeric Separators
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in Pain Perception
研究概览
简要总结
The aim of this study is to evaluate the effect of low level laser therapy (LLLT) on pain management in people commencing orthodontic treatment. The study design is a randomized controlled trial.
Participants' pain will be dealt with by laser irradiation in one side of the jaw randomly, and the other side will be treated by a placebo procedure. Pain assessment will be measured using Visual Analog Scales (VAS).
The hypothesis of this study is that laser irradiation decreases the amount of pain following the insertion of orthodontic separators.
详细描述
Here we have two groups:
The first group will undergo one dose of irradiation which is going to be applied on one side of the mouth whereas the opposing side will serve as a control side (placebo).
The second group will undergo two doses of irradiation which is going to be applied on one side of the mouth whereas the opposing side will serve as a control side (placebo).
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 (Participant)
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants should have healthy periodontal structures, healthy teeth.
- •Presence of first molar in both side of the jaw.
排除标准
- •systemic diseases
- •chronic pain or neurological pain
研究组 & 干预措施
Laser Irradiation One Dose
Laser irradiation will be applied in one dose for patients in this group, but only on one side of the jaw. The other side of the jaw will receive a placebo procedure (i.e. a red light beam will be emitted on the gingival tissues as if they are irradiated by a laser beam).
干预措施: Laser Irradiation One dose (Radiation)
Laser Irradiation Two doses
Laser irradiation will be applied in two doses for patients in this group, but only on one side of the jaw. The second dose will be given after 24 hour of the first one. The other side of the jaw will receive a placebo procedure (i.e. a red light beam will be emitted on the gingival tissues as if they are irradiated by a laser beam).
干预措施: Laser Irradiation Two doses (Radiation)
结局指标
主要结局
Change in Pain Perception
时间窗: Pain will be evaluated at 1, 6, 24, 48, and 72 hours after laser irradiation
Pain assessment will be performed using a Visual Analog Scale (VAS).
次要结局
未报告次要终点