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临床试验/NCT05476445
NCT05476445已完成不适用

Comparison of the Effect of Cryotherapy Application and Low Level Laser Application on Post-Operative Pain in Primary Molar Teeth With Apical Periodontitis

Ataturk University2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年5月2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
75
试验地点
2
主要终点
Wong Baker wong baker faces pain rating scale

研究概览

简要总结

The aim of this study is to evaluate the effect of low-level laser therapy (LLLT) and intracanal cryotherapy applications on postoperative pain in endodontic interventions of primary molar teeth with apical periodontitis. 75 patients were randomly assigned to the control, low-level laser and cryotherapy groups.Root canal treatments were performed in a single session. The pain intensity felt by the patients on the preoperative and postoperative 1st, 3rd, 5th and 7th days were recorded using the Wong Baker visual pain scale. Preoperative and postoperative 7th day percussion sensitivity was recorded using the VAS (visual analog scale) scale. The pain scores of the groups at different times after the procedure were compared. Statistical analysis of the data was performed at the 0.05 significance level.

详细描述

Patient Selection Criteria This study will be on primary molar teeth with acute pain at Atatürk University Faculty of Dentistry, Department of Pedodontics. While calculating the sample value, the effect value of Gundogdu et al.(2018) in terms of 1 day use in the evaluation was taken as 0.85, the standard deviation was 20, the α value was 0.05 and the β value was 95%, and the sample value was selected as 9 patients for each group. However, those who would be in good standing were in the unit 0.37 in the good group and in the 80% strong component, 0.05 significance elements were 75 samples for 3.

Treatment Protocol For treatment, 75 samples were first randomized with a web program (www.randemizer.org). According to this randomization, the incoming controls were separated from the leveled therapy (LLLT group) and intracanal cryotherapy (cryotherapy group) divisions (n=25).

The information about the data received for the study and the data related to the analysis are studied. Patients were treated by a single clinician.

The current pain intensity felt by the patients was determined using the Wong Baker visual pain assessment scale. In the evaluation of preoperative percussion sensitivity, a 10 cm VAS scale marked by the patient after the percussion test was used.

The teeth to be treated in each group were anesthetized using 1.8 ml of articain HCl (Ultracain DS; Pharma Vision San. ve Tic. A.Ş., Istanbul, Turkey) containing 1:100,000 epinephrine.After ensuring that anesthesia was provided, treatment was started.

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
Double (Participant, Outcomes Assessor)

盲法说明

Patients and the assessor don't know the study group names.

入排标准

年龄范围
6 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • The informed consent form is signed by the parent,
  • The patient is between the ages of 6-9,
  • The patient is cooperative (Frankl scale category 3 and 4),
  • Having a history of spontaneous pain in primary molar teeth,
  • Percussion sensitivity value before treatment is 5 or above 5 on the VAS pain scale,
  • Presence of a primary molar tooth with acute or chronic infection in its pulp,
  • When the crown pulp of primary molar teeth is removed, the bleeding in the root pulp does not stop or does not exist within 5 minutes,
  • Primary molars that can be isolated with rubber-dam,

排除标准

  • Patients with any systemic disease (including conditions requiring antibiotic prophylaxis) or psychiatric problems,
  • Patients who used any analgesic, anti-inflammatory or antibiotic in the last 1 week in the last 24 hours before root canal treatment,
  • Patients who are allergic to the materials used in the treatment,
  • Primary molar teeth with excessive crown destruction that cannot be restored,
  • Primary molar teeth with bone loss between roots exceeding 1/3,
  • Having previously applied root canal treatment or amputation treatment in the relevant tooth,
  • Presence of internal/external and physiological root resorption in the relevant tooth,
  • Teeth with root fracture, ankylosis or mobility (Miller mobility classification 3 and 4),
  • Teeth with excessive crown destruction that cannot be restored or a rubber-dam can be placed,

结局指标

主要结局

Wong Baker wong baker faces pain rating scale

时间窗: postoperative (7th day)

Patient's current pain. Scores between 0 to 5. Higher score means worse outcome.

Visual Analog Scale (VAS)

时间窗: postoperative 7th day

Percussion pain of tooth. Scores between 0 to 10. Higher score means worse outcome.

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

Muhammed Talha Çetin

Principal Investigator

Ataturk University

研究点 (2)

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