跳至主要内容
临床试验/NCT07747350
NCT07747350招募中不适用

Comparison Between the Effectiveness of Low-Grade Laser Therapy vs. Conventional Analgesics for Pain Reduction During Orthodontic Treatment in Malay Female Population

ROA RAAD FADHEL1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Pain Intensity Score

研究概览

简要总结

All patients will be treated using the fixed appliance on the upper and lower arches.

0.014" Niti(Nickel-Titanium) archwire is used to ensure all patients will receive the same force.

All participants will receive a pain diary. In the pain diary, they are required to complete a KAP(Knowledge, Attitudes, and Practices) questionnaire regarding pain before the procedure. They are also required to record the pain VAS (Visual Analog Scale) score at different times (before procedure, 6 hours, 12 hours, 24 hours, 3 days, 5 days and 7 days after procedure). For PCM (Paracetamol) 650mg group, 1 tablet will be given 1 hour before the procedure and every 6 hours for 24 hours (5 doses in total) as pain begins two hours after activation, peak at 24 hours and reduces after two days . Paracetamol if taken more than 4g per day may cause serious liver damage. United State of Food and Drugs Administration recently suggested a maximum daily dose of 3g to reduce risk of overdosing . Based on literature, 1000mg PCM(Paracetamol) is more efficient as postoperative analgesics 1000mg vs 650mg vs placebo. However, this study reported a single dose application (up to 6 hours). In view of continuous pain sensation experience by orthodontic patients (peak at 24 hours), we concluded that 650mg 6 hourly is more appropriate to control pain experienced by participants. For LLLT (Low-Level Laser Therapy) group: ezlase diode laser beam (Biolase, USA) for soft tissue operated at 940nm wavelength will be applied using a quadrant-sized probe that covers region form central incisor to first molar at the level of cervical third of the root, perpendicular and in light, direct contact with the buccal and palatal mucosa for the upper arch and buccal and lingual mucosa for the lower arch from UR6-UL6 and LR6- LL6 for 30 seconds each site . Patients will be monitored up to 1 hour after the LLLT ( Low-Level Laser Therapy) application for any adverse reactions. All procedures will be conducted in the morning session from 9am- 11am. Due to variability of pain experienced throughout the day , patients are advised to record pain in the morning to reduce the variability in VAS (Visual Analog Scale) score.

All the procedures and baseline score will also be conducted and recorded in the morning.

During the follow-up appointment (1 month after bond-up) Patients are required to re-answer the KAP (Knowledge, Attitudes, and Practices) questionnaire (post bond-up) in the pain diary. Pain diary will be collected for data analysis.

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
None

入排标准

年龄范围
18 Years 至 33 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18- 33 years old
  • Fit and Healthy
  • New patients who have not received any orthodontic treatment

排除标准

  • Patient with a history of pain and medical problem
  • Patient who had taken medication for the past 2 weeks before orthodontic treatment
  • Patient with craniofacial deformities

研究组 & 干预措施

Conventional Analgesics Group

Active Comparator

Participants in this group will receive conventional oral analgesics (e.g., Paracetamol) for pain relief following orthodontic activation

干预措施: Conventional Analgesic (Paracetamol) (Drug)

Low Level Laser Therapy Group

Experimental

Participants in this group will receive Low-Level Laser Therapy (LLLT) following orthodontic archwire placement or adjustment to evaluate its effectiveness in reducing orthodontic pain

干预措施: Low-Level Laser Therapy (LLLT) (Device)

结局指标

主要结局

Pain Intensity Score

时间窗: Assessed at 6, 12, 24, 48, and 72 hours following archwire placement

Pain evaluated using the Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain)

Orthodontic Pain Score

时间窗: Assessed at 6, 12, 24, 48, and 72 hours following archwire placement

Pain evaluated using the Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain)

次要结局

未报告次要终点

研究者

发起方
ROA RAAD FADHEL
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

ROA RAAD FADHEL

dentist

Universiti Sains Malaysia

研究点 (1)

Loading locations...

相似试验