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临床试验/NCT03818906
NCT03818906已完成不适用

Efficacy of aPDT in Reducing Pain and Swelling Following Molar Extraction Surgery- Blinded Randomized Controlled Clinical Trial

Universidade Federal Fluminense2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年8月1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
40
试验地点
2
主要终点
reduction of postoperative pain

研究概览

简要总结

This project aims to evaluate the effect of antimicrobial photodynamic therapy (aPDT) on the reduction of swelling and postoperative pain in lower molar extraction procedures. This is a clinical study approved by the Research Ethics Committee, which will be performed in 40 patients between 20 and 60 years. Patients included in the study should have at least one lower molar (first or second molar) with indication of exodontia. Participants will follow the exclusion criteria: pregnant or breastfeeding women; patients with obesity (Body Mass Index - BMI); make use of any activity smokers and ex smoker to 6 months; diabetics; immunosuppressed; in osteoporosis; making use of antimicrobials in the last 3 months; making use of medications that interfere with bone remodeling; with cysts or tumors in place. Surgical procedures that exceeded the clinical time of 30 minutes and / or required opening of the flap or osteotomy were excluded from the study. After the sample calculation, forty patients will be involved in this project, where forty molars (first and second molars) will be extracted in the mandible, which will be randomly divided into 4 groups. The control group (C.G), will contain 10 patients, where 10 molars will be extracted in a conventional way, without any additional treatment to be done. Test group 1 (T.G1) will contain 10 patients where 10 molars will be extracted and immediately after extraction, the fresh sockets will receive in their inner portion a local application of aPDT. The test group 2 (T.G2) will present 10 patients, where 10 molars will be extracted that immediately after the exodontia, the fresh socket will receive local application of infrared in the outer vestibular portion. Finally, Test Group 3 (T.G3), will be composed of 10 patients, where 10 molars will be extracted, joining the approaches of the previous groups (aPDT + infrared). Pain intensity will be assessed through a visual analogue scale and swelling assessed by measuring a perimeter between the tragus, the base of the jaw and the commissure of the lips. The data will be collected in four moments: before the surgery, 72 hours, 7 days and 30 days postoperatively.

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 (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients without systemic limitations that indicate surgical procedures with cooperative behavior
  • with full awareness and approval of the guidelines listed in the free and clarified term proposed by the research
  • present compromised posterior and inferior teeth requiring exodontia.

排除标准

  • Pregnant or breastfeeding women
  • Patients with obesity (Body Mass Index - BMI)
  • Make use of any activity smokers and ex smoker to 6 months
  • Diabetics
  • Immunosuppressed
  • in osteoporosis
  • making use of antimicrobials in the last 3 months
  • making use of medications that interfere with bone remodeling
  • with cysts or tumors in place
  • Surgical procedures that exceeded the clinical time of 30 minutes and / or required opening of the flap or osteotomy

结局指标

主要结局

reduction of postoperative pain

时间窗: Pain evaluation will be performed prior to the surgical procedure and 7 days after

Evaluate Antimicrobial photodynamic therapy (aPDT)on the reduction of postoperative pain in lower molar extraction procedures. Pain intensity will be assessed through a visual analogue scale

reduction of swelling

时间窗: The data will be collected in four moments: before the surgery, 72 hours, 7 days and 30 days postoperatively.

Evaluate Antimicrobial photodynamic therapy (aPDT)on the reduction of swelling. Swelling evaluated through the measurement of a perimeter between the tragus, the base of the mandible and the commissure of the lips

次要结局

未报告次要终点

研究者

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

Livia Azeredo Alves Antunes

Professor Lívia Azeredo Alves Antunes

Universidade Federal Fluminense

研究点 (2)

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