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临床试验/CTRI/2026/03/105401
CTRI/2026/03/105401尚未招募2/3 期

Effect of Vibration System on Pain Perception during Dental Anesthesia in children: A Randomised Controlled Trial

Dr PRATYAKCHA JHA1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2026年3月21日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
42
试验地点
1

研究概览

简要总结

The randomized control trial aims to evaluate the effectiveness of a vibratory dental device(Dental vibe) in reducing pain perception during administration of local anesthesia in children aged 4-9 years .A total of 42 participants will be randomly allocated into two parallel groups: a control group receiving  topical benzocaine gel prior to conventional infiltration anesthesia ,and a test group receiving vibratory stimulation using Dental vibe during injection. Pain perception will be assessed using WONG BAKER FACES Pain rating scale, FLACC scale and SEM scale by both self report and external observer evaluation. Standardized injection techniques anesthetic volumes and operator consistency will be maintained. statistical analysis will be conducted using non parametric tests .the study hypothesizes that vibratory stimulation will significantly reduce pain compared with conventional topical anesthesia, based on the gate control theory of pain modulation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
4.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • (1)Children 4 TO 9 years of age.
  • (2) Positive or definitely positive behavior on Frankl scale.
  • (4)Children with no known history of allergies.
  • .(5) Parental consent for child participation in the study.
  • (6) Patients who are getting administered with Local Anaesthesia for the first time.

排除标准

  • (1)Those in need of treatment under general anesthesia (2) Children with special health care needs.

研究者

发起方
Dr PRATYAKCHA JHA
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

PRATYAKCHA JHA

Meenakshi Ammal Dental College and Hospital Tamilnadu

研究点 (1)

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