Monocentric, Randomized, Single Blinded Study Designed to Evaluate the Effect of Low Level Laser Therapy on Pain Occurring After Insertion of an Orthodontic Device : the "Quadhelix"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- to evaluate the effect of low level laser therapy on pain induced by insertion of the quadhelix (orthodontic device)
研究概览
简要总结
Thus study consists of evaluating the effect of low level therapy on pain induced by insertion of an orthodontic device (the "quadhelix"). Each day during the first seven days post procedure, the level of pain will be reported on an analogic visual scale.
As secondary objectives, intake of antalgics and type of swallowed food (soft or tough) will also be daily registered.
详细描述
Patient will be randomized into one of the 3 following arms :
- arm 1 (experimental) : administration of Low Level Laser Therapy just after insertion of the quadhelix.
- arm 2 (sham procedure) : material necessary to perform Low Level Laser Therapy will be installed but the laser will not be activated.
- arm 3 (no intervention): material necessary to perform Low Level Laser Therapy will NOT be installed
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
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 8 and 15 years old who need to receive an orthodontic device ("quadhelix)
- •informed consent form signed by parents who should be affiliated to French health insurance (french Social security)
排除标准
- •malignant facial tumor
- •not able to read or write correctly and thus not able to complete the questionnaire
- •allergic or intolerant to paracetamol
- •Informed consent not obtained
研究组 & 干预措施
Low level laser therapy
Low level laser (970nm) will be delivered on the mucous membrane in regard to the first molar teeth on which rings of the quadhelix have been settled.
干预措施: Low level laser therapy (Device)
sham procedure
Same procedure than experimental arm except that the laser is not activated.
干预措施: sham procedure (Procedure)
no intervention
no intervention : Patient received the quadhelix with nothing else
结局指标
主要结局
to evaluate the effect of low level laser therapy on pain induced by insertion of the quadhelix (orthodontic device)
时间窗: change from baseline pain at 7 days
Each day during the first week post procedure, patient will record intensity of his/her pain on an analogic visual scale
次要结局
- effect of low level laser therapy on intake of antalgics(change from baseline antalgics intake at 7 days)
- quality of food intake(change from baseline quality of food intake at 7 days)