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临床试验/NCT05255731
NCT05255731已完成不适用

Effect of the Low Power Laser in the Treatment of Pain After the Third Molar Lower Extraction. A Randomised Single-blind Clinical Trial Split-mouth

University of Santiago de Compostela2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Evaluate edema after surgery

研究概览

简要总结

Introduction: Previously published studies report a prevalence ranging from 35.9% to 58.7% of the general population with at least one impacted wisdom tooth. Surgical extraction of wisdom teeth is the procedure most often associated with postoperative complications, such as pain, swelling, trismus, and oral discomfort during the first postoperative days. These complications arise from an inflammatory response, which is a direct and immediate consequence of the surgical intervention and can limit the patients' daily functions in the recovery phase and compromise their quality of life. Several methods have been used to control postoperative morbidity related to wisdom tooth extraction, including administration of proteolytic enzymes, tube drains, cryotherapy, anti-inflammatory and analgesic drugs and low level laser therapy.

Objectives: To test whether the use of low power laser can improve post-operative pain, swelling and healing of the surgical wound.

Material and methods: A double-centre, randomised, split-mouth, double-centre clinical study will be carried out in 38 patients per centre, totalling 76 patients and 152 wisdom teeth, who will undergo surgery for the extraction of the lower third molars. The necessary data for the study will be taken on the days of the consultation for surgery planning, on the day of surgery, by the patient on each post-operative day and on the 7th post-operative day (at the time of suture removal ).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

One side the laser off will be applied, on the other side, the laser on will be applied,

入排标准

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

入选标准

  • Patients who require extraction of the two lower wisdom teeth due to previous infection or pain, orthodontics or crowding, caries and who have a similar degree of difficulty according to the Pell and Gregory/Winter classifications.
  • Patients must have the capacity to understand and decide at the time of voluntarily signing the informed consent before any intervention related to the study is performed.
  • Patients who, after being informed about the aims and procedures of the research, agree and sign the informed consent form. Patients must be willing and able to adhere to the study in order to complete the necessary visits.

排除标准

  • Patients with uncontrolled systemic disease (ASA ≥ III).
  • Patients with severe periodontal disease or acute pericoronitis.
  • Smokers of more than 5 cigarettes per day.
  • Pregnant and lactating women, as the effect of laser therapy in this population has not been studied, its use is contraindicated.

结局指标

主要结局

Evaluate edema after surgery

时间窗: 7 days

To evaluate the effect of diode laser radiation of 808 nm (infrared) applied intra and extra-orally on the post-operative edema (by measuring in centimetres obtained by a ruler - external contour of the face from the tragus to the labial comisure, from the gonion to the external ocular corner, the greater the measurement obtained, when compared with the initial measurement, the greater the post-operative edema).

次要结局

  • Reported pain(7 days)
  • Rescue medication for pain(7 days)
  • Trismus(7 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mario Pérez Sayáns

Professor

University of Santiago de Compostela

研究点 (2)

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