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临床试验/NCT02602431
NCT02602431Unknown不适用

A Unique Application of Low Laser Therapy After Third Molar Surgery: A Randomized Controlled Clinical Trial

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Change in Pain Scores on the Visual Analog scale

研究概览

简要总结

Third molars extraction is a surgery frequently performed in dentistry. It is generally associated to a great postoperative distress rendered by pain, swelling and trismus, caused by surgical trauma inflammation. Several methods have been proposed to prevent these complications and to increase tissue repair quality. The use of low level laser therapy (LLLT) has been reported in dentistry since 1970. A large number of studies have reported the benefits of LLLT without collateral damage, positive effect as an anti-inflammatory agent and benefits in accelerating wound repair. However, some clinical applications strategies have been contradictories in everyday practice with results not always equivalent.

Objective: To verify if a single LLLT intra or extra oral application, singly, are analogous in their effects in controlling postoperative edema, trismus, pain and wound repair in third molar surgery.

详细描述

30 healthy participants of both genders, with 18 to 35 years-of-age, with the necessity of inferior bilateral third molar removal will be selected. Inclusion criteria will consider the presence of upper central incisive and same surgical difficulty for third molar extraction. Participants that present chronic TMJ pain, neurological or psychiatric disorders, pericoronitis, anti-inflammatory or analgesic use for the last 15 days, bisphosphonates usage history at any time, tabagism, pregnancy or a family history of photosensitivity and hypersensibility to analgesics, anti-inflammatory or antibiotics will not be included. The surgical procedures will be randomized for the group to be assigned respecting the interval of one month between the surgeries.

Intra-oral group (IO) will be that in whose participant will receive the LLLT (Photon Lase III DMC equipment) with 660 nm wavelength, 100 mW of power, 107J / cm2 of power density, during 30 seconds, positioning the tip of the laser device in straight contact with each of the four points in the surgical area:

  1. corresponding to the occlusal surface of the tooth surgically extracted,
  2. in the middle third of the lingual surface, point
  3. the middle third of the buccal surface and point
  4. retro molar triangle region. Each point will receive energy 3J (Et= 12J).

The extra-oral group (EO) will receive phototherapy with the 808nm of wavelength following the same above protocol although positioning the laser point over the skin in straight contact with four points on the masseter muscle:

  1. next jaw insert,
  2. lower middle region,
  3. upper middle region
  4. near the insertion of the zygomatic arch.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •necessity of bilateral impacted third molar removal with similar dental arch positioning and similar surgical difficulty.

排除标准

  • •Compromised Systemic Health status, Neurologic and/or mental disorders, local infection history, anti-inflammatory or analgesic use for the last 15 days, tabagism, ethylism, pregnancy.

研究组 & 干预措施

Intra-oral laser irradiation

Active Comparator

red wave laser, 660nm, 100mW, and 107J/cm2

干预措施: Intra-oral laser irradiation (Device)

Extra-oral laser irradiation

Active Comparator

infra-red wave laser, 660nm, 100mW, and 107J/cm2

干预措施: Extra-oral laser irradiation (Device)

Extra-oral placebo

Placebo Comparator

Laser point will be placed in region without irradiation on.

干预措施: Extra-oral placebo (Device)

intra-oral placebo

Placebo Comparator

Laser point will be placed in region without irradiation on.

干预措施: Intra-oral Placebo (Device)

结局指标

主要结局

Change in Pain Scores on the Visual Analog scale

时间窗: 4, 6, 8, 24, 48hours post operative period

measurements in a diary after anesthetic sensation had stopped and 4, 6, 8, 24, 48hours post operatively

次要结局

  • Edema percentage(24 hours after surgery)
  • mouth aperture in millimeters(24 hours after surgery)

研究者

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

Maria Cristina Zindel Deboni

Associate Professor

University of Sao Paulo

研究点 (1)

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