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临床试验/NCT02169102
NCT02169102已完成不适用

Effect of Low Power Laser in Pain Modulation During Irreversible Inflammation of Tooth Pulp

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Tooth pain modulation during irreversible pulp inflammation after low power laser irradiation

研究概览

简要总结

Anxiety, pain and discomfort are common stressful situations that occur during the dentistry practice, especially in the urgency endodontic practice. Studies have concluded that low intensity laser therapy is effective in treating pain. However, most studies have reported the low intensity laser therapy in chronic pain, few studies have shown its application on acute pain and none have evaluated the low intensity laser´s analgesic effect in acute pain of the pulp inflammation. Since the pulp tissue has the peculiar characteristic to be surrounded by dentin, in acute pulpits, the inflammatory reaction is more complicated than usual. Furthermore, during the inflammatory process, sometimes anesthesia is not always completely effective. Thus, this present study aims to evaluate whether previous therapy with low intensity laser could, by its analgesic effect, promote greater comfort especially to this type of patient. 60 patients with acute pulpits pain will be selected to this study (randomized and double-blinded) and they will be divided in 4 groups:

Group 1 ( n=15) - Control Group; Group 2 (n=15) - Laser 1: 780 nanometers (nm); 40 milliwatts (mW); 4 seconds per point; 0.16 Joules/point; total irradiated points: 02; Group 3 (n=15) - Laser 2: 780nm; 40 mW; 40 seconds per point; 1.6 Joules/point, total irradiated points: 02; Group 4 (n=15) - Placebo group - Sham Laser Irradiation.

The pain will be evaluated by a visual analogue scale (VAS) in 3 different times: initial pain, pain immediately after and 15 minutes after interventions (laser irradiation, or sham laser irradiation). After that, patients with acute pulp irreversible inflammation will be submitted to conventional endodontic urgency treatment. Data concerning the need of complimentary local anesthesia will be also taken into account. Data of different groups and times will be statistically compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • Patients with acute pain due to irreversible inflammation of the a vital pulp tooth

排除标准

  • Non-Intact Pulp chamber
  • Necrotic pulp

结局指标

主要结局

Tooth pain modulation during irreversible pulp inflammation after low power laser irradiation

时间窗: Immediately after low power laser irradiation and 15 minutes after low power laser irradiation

Pain will be measured through VAS (Visual Analog Scale).

次要结局

  • Need of anesthetic supplementation during urgency endodontic treatment(15 minutes)

研究者

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

Karen Müller Ramalho

PhD

University of Sao Paulo

研究点 (2)

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