Evaluation of the Use of Photobiomodulation After the Installation of Elastometric Separators - Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 1 期
- 入组人数
- 72
- 主要终点
- Visual Analog Scale (pain measurement)
研究概览
简要总结
The greatest dropout rate of orthodontic treatments is pain, from the installation of the elastomeric separators, to the exchange of wires and accessories. This process that presents both physiological and psychological responses negatively affects patients' quality of life due to the difficulty of chewing and biting. The sample will be comprised of individuals who will receive elastomeric spacers on the mesial and distal surfaces of the upper first molars, randomized into two groups, the group being irradiated with the low intensity laser, called the experimental group, and the placebo group, simulated laser. In the installation of the tabs, the experimental group will receive a single application in the mesial and distal cervical portion and in the apical third of the molars. The energy delivered at each point will be 2J, per vestibular and lingual, 6 points, totaling 12 J of energy per tooth. To evaluate the perception of pain we will use the Visual Analogue Scale (EVA) after 1h, for all groups. The gingival pockets cytokines will be collected with an absorbent paper cone for 30 seconds on both groups and compared between them by ELISA. It is expected that patients in the irradiated group will have lower pain perception and less cytokines than in the placebo group.
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)
盲法说明
In the Placebo group, participants will receive the simulated application with the laser set off, only using the beep to play the application. Therefore, they not know to which group they belong.
入排标准
- 年龄范围
- 12 Years 至 26 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical conditions of normality;
- •Healthy periodontium;
- •Healthy molars;
- •Presence of interproximal contacts between the second molar and premolar;
- •Permanent dentition phase;
- •Who have not been taking anti-inflammatory drugs or analgesics for 4 days.
排除标准
- •Systemic diseases that routinely use medications;
- •Patients with periodontal disease;
- •Patients who remove the tabs or who do not respond to the questionnaire;
- •Papers contaminated with blood or saliva will be excluded for cytokine analysis.
研究组 & 干预措施
Experimental group
In this study, immediately after the installation of the separators, the subjects of the experimental group will be submitted to photobiomodulation. The laser will be infrared, in continuous mode with wavelength of 808 nm. The tip will be positioned perpendicularly in the mucosa, without exerting pressure. At each point 2J of energy will be irradiated for 20 seconds, totaling 12J per tooth, 6J on the buccal side and 6J of the lingual side of the teeth.
干预措施: Photobiomodulation (Radiation)
Placebo group
In the placebo group, the same procedures will be made, but the laser will be switched off.
干预措施: Placebo photobiomodulation (Radiation)
结局指标
主要结局
Visual Analog Scale (pain measurement)
时间窗: Immediately after treatment.
After an hour of installation of the separators, patients will respond to pain perception, being instructed to quantify their level of discomfort by measuring the VAS. The scale was converted into 11 points, 0 to 10, where 0 refers to the absence of pain and 10 levels of intolerable pain.
次要结局
- Change in IL-8 cytokine(Baseline and immediately after treatment.)
研究者
Sandra Kalil Bussadori
Principal Investigator
University of Nove de Julho
