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临床试验/CTRI/2025/07/091525
CTRI/2025/07/091525尚未招募2 期

Laser photobiomodulation synergy with lignocaine and tramadol An In vivo study

Dr Shlesha Sheth1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年8月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Photobiomodulation increases depth of anesthesia during access cavity preparation.

研究概览

简要总结

Total of 80 vital maxillary molar teeth requiring root canal treatment

All the teeth are allocated in 4 groups as per anesthesia and laser photobiomodulation

Infiltration anesthesia will be given . Lignocaine(0.6ml) Tramadol(0.4ml)

Group 1

Lignocaine plus Tramadol

|Group 2

Lignocaine plus Photobiomodulation

|Group 3

Tramadol plus Photobiomodulation

|Group 4

Lignocaine plus Tramadol plus Photobiomodulation

Endo access bur will be used for access cavity preparation and while performing the treatment for each group, the evaluation was repeated and the Visual Analog scale VAS recorded during dentin cutting VAS 1 and at entry into the pulp VAS 2. The patient’s response will be noted based on VAS score during dentin cutting, and during pulp dropping

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Vital Maxillary Molar requiring Root Canal Treatment.
  • Vitality Test : Positive or prolonged response (Using Cold test & Electric pulp test).

排除标准

  • Non-Vital teeth.
  • All other maxillary teeth.
  • Mandibular teeth.
  • Teeth with periapical lesion.
  • Patients allergic to lignocaine (local anesthetics).
  • Pregnant & lactating women.
  • Patients having habit of alcohol.
  • Those who have systemic diseases, immunocompromised conditions, psychiatric condition.

结局指标

主要结局

Photobiomodulation increases depth of anesthesia during access cavity preparation.

时间窗: Visual analogue scale(VAS) for pain perception recorded during dentin cutting (VAS 1) and at entry into the pulp (VAS 2). The patient’s response will be noted based on VAS score during dentin cutting, and during pulp dropping(assessment while ongoing root canal treatment within 2hours of anesthesia delivery)

次要结局

  • Chances of achievement of Pulpal anesthesia increases when tramadol hydrochloride & lignocaine hydrochloride both are administered.(Visual analogue scale(VAS) for pain perception recorded during dentin cutting (VAS 1) & at entry into the pulp (VAS 2). The patient’s response will be noted based on VAS score during dentin cutting, & during pulp dropping while ongoing root canal treatment only.( within 2 hours of anaesthesia delivery))

研究者

发起方
Dr Shlesha Sheth
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Shlesha Sheth

Narsinhbhai Patel Dental college and hospital

研究点 (1)

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