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临床试验/CTRI/2024/12/078537
CTRI/2024/12/078537尚未招募不适用

EVALUATION OF PAIN ASSESSMENT USING A NEUROMODULATION DEVICE AFTER SEPARATOR PLACEMENT: AN IN-VIVO STUDY

Rahul Yadav1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2025年1月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
21
试验地点
1
主要终点
Pain Perception and Assessment Using Wong Baker And Numeric Rating Scale

研究概览

简要总结

This prospective split mouth study, 2 quadrants of the patient’s mouth having  randomly assigned into Experimental and Control groups.To investigate patient discomfort after separator placement during orthodontic treatment, patients will be  treated with a split-mouth design where one side of the arch will be treated with neuromodulation device with on mode (Experimental group) and  the other half of the arch with just mechanical application of the device with no current (Control group) . During the whole process, the patient will not be aware that in which side of the mouth the device will be used with on mode and which side with no current.The device will be switched on by pressing the single press button. A blue light will be seen that will stay on for 1 second which means the device is powered on. Once the blue light starts blinking, the device will be ready to use. Will place the two metal probes on the gingival area of the tooth visualizing the roots of the tooth for 20 seconds. Device movement will be done both in horizontal and vertical direction gently for 20 seconds each.    The patient will be asked to rate the intensity of pain after neuromodulation device application immediately after placement of separators then after 4 hours , 24 hours and 48 hours on a Wong-Baker smiley scale and Numeric Rating Scale (NRS)

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Investigator Blinded

入排标准

年龄范围
12.00 Year(s) 至 24.00 Year(s)(—)
性别
All

入选标准

  • Patients with completely erupted upper first and second molars and compact interproximal contact areas on both upper first molars with healthy periodontal conditions
  • Patients with good oral health.
  • Patients ranging from the age of 12 to 24 years are selected for the study.

排除标准

  • Pregnant patients.
  • Patients with the history of seizures, cardiac arrythmia or pacemaker treatment.
  • Patients who were taking any over the counter or prescription pain medication during the testing period.
  • Interproximal caries or restoration
  • Extracted or missing teeth
  • Periodontally compromised teeth
  • Orofacial pain.

结局指标

主要结局

Pain Perception and Assessment Using Wong Baker And Numeric Rating Scale

时间窗: 2 Days

次要结局

  • Pain Perception Is Minimum In Experimental Group(2 Days)

研究者

发起方
Rahul Yadav
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

RAHUL YADAV

SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCE AND RESEARCH

研究点 (1)

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