CLINICAL STUDY OF BIOSTIMULATION WITH LOW-POWER DIODE LASER AFTER DENTAL EXTRACTIONS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Pain Intensity (Self-Reported Visual Analog Scale - VAS, 0-10)
研究概览
简要总结
the objective of the present work is to assess the efficacy of photobiomodulation (PBM) with respect to pain, inflammation, and healing after tooth extractions as compared with a sham treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients who needed tooth extractions for any reason and who signed an informed consent form
排除标准
- •patients who according to the ASA preoperative evaluation, did not meet the medical con-ditions for a surgical intervention. Immunocompromised patients. Patients with decom-pensated systemic diseases; undergoing chemotherapy treatment or taking immunosup-pressants. Pregnant women. Patients with severe mental disorders. Patients who had re-ceived head and neck radiotherapy
研究组 & 干预措施
Group I (Experimental):
patients subjected to a tooth extraction and immediately given an intraoral PBM session with an EPIC X Biolase diode laser (BIOLASE, Inc. USA), . It was applied at three points in the area: buccal, pala-tal/lingual, and occlusal to stimulate the tissue
干预措施: laser (Device)
Group Sham
patients undergoing tooth extraction and the application of inactive/simulated PBM im-mediately after using the same procedure
干预措施: laser (Device)
结局指标
主要结局
Pain Intensity (Self-Reported Visual Analog Scale - VAS, 0-10)
时间窗: Self-reported Pain Scores Using 0m Visual Analog Scale 10 Pain Score.Total pain improvement over day 0 to day 7
hange in self-reported pain scores from Day 0 to Day 7 using a 0-10 Visual Analog Scale (VAS), where 0 = no pain and 10 = worst imaginable pain.
次要结局
未报告次要终点