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临床试验/NCT04280809
NCT04280809已完成不适用

Postoperative Analgesic and Anti-inflammation Effects of Low-level Laser Therapy After Surgical Removal of Impacted Lower Third Molar

University of Medicine and Pharmacy at Ho Chi Minh City2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
2
主要终点
Pain degree

研究概览

简要总结

Goal: The aim of this study was to evaluate the effects of low-level laser (LLL) after surgical removal of impacted lower third molars (ILTM).

详细描述

Goal: The aim of this study was to evaluate the effects of low-level laser (LLL) after surgical removal of impacted lower third molars (ILTM), including pain level, postoperative facial swelling, trismus and non-stimulated saliva secretory immunoglobulin A (sIgA).

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 (Investigator)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • had two impacted lower third molars symmetrically in the same position as the classifications of Pell- Gregory and Winter diagnosed by 2D panoramic radiography

排除标准

  • Patients with systemic diseases such as cardiovascular disease, hypertension, diabetes mellitus, pregnant, local infections
  • refused to participate in the study
  • patients who did not follow-up visit would be excluded

结局指标

主要结局

Pain degree

时间窗: at 48 hours after surgery

Likert scale

sIgA concentration

时间窗: the second day after surgery

Firstly, the saliva sample was centrifuged for 10 minutes, speed 3000 rpm, at 40 degrees Celsius. After eliminating oral mucosa cells, red blood cells, the 500 µl of the sample solution was added 5 µl proteolytic inhibitor to avoid cleavage of the sIgA antibodies in the sample to be investigated. The sample was vibrated with a vortex vibrator for 20 seconds and stored in -80°C. After collecting enough samples, the samples were performed the Elisa sandwich procedure according to the standard instructions of Kit Elisa Elabscience Human Secretory IgA (Elabscience Biotechnology, Houston, Texas, US) using Elisa IRE 96 SFRI Kit reader 450nm (SFRI, Saint-Jean-d'Illac, France)

Face swelling degree

时间窗: on second day after surgery

Mark indelibly on the skin of points used to record the preoperative swelling level based on benchmarks A, B, C, D. A was the external canthus of the eye, B was the Gonion, C was the lip-commissure and D was the lowest point of the earlobe. The degree of face swelling was determined by using measuring tape (rounded to the nearest millimeter line): vertically from the external canthus of the eye to the Gonion (segment AB) and horizontally: from earlobe to the lip-commissure (CD segment). To evaluate generally face swelling, we computed the swelling area (mm2) approximately by the formula AB\*CD/2

Trismus degree

时间窗: on day 2 postoperatively

measuring the distance between the mesial angle of the central incisors of the upper and lower (maximum oral aperture, MOA) of the patient with a caliper

次要结局

未报告次要终点

研究者

发起方
University of Medicine and Pharmacy at Ho Chi Minh City
申办方类型
Other
责任方
Principal Investigator
主要研究者

Le Thanh Thai Ha

Faculty of Odonto-Stomatology

University of Medicine and Pharmacy at Ho Chi Minh City

研究点 (2)

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