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临床试验/CTRI/2022/09/045460
CTRI/2022/09/045460已完成不适用

Comparative evaluation of the effectiveness of transcutaneous electric nerve stimulation and photobiostimulation using diode laser prior to local anesthesia administration in children undergoing bilateral orthodontic extractions: a randomised controlled clinical trial

ITS Dental college hospital and research centre1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年9月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Anxiety levels will be measured using- Salivary alpha amylase level, salivary pH ,Pulse rate FLACC SCORE FOR PAIN

研究概览

简要总结

Pain management is an important aspect of paediatric dentistrysince it influences the patient’s behavior during the session and maintains compliance for future appointments. Local anesthesia (LA) is required for pain relief during a variety of restorative, endodontic, and small surgical treatments. However, the methods used to alleviate pain may be a source of both discomfort and worry in children and youngsters.

Increased anxiety can alter a child’s sense of pain, making it more difficult for them to receive the best and most required dental care. The degree of pain associated with local anesthetic administration has been ascribed to a variety of parameters  including injection speed, pressure during administration, injection site, pH, volume, and temperature of the anesthetic solution.

Pain relief during injection has been recommended using a variety of ways. Reframing, utilizing distractions, and making positive recommendations are examples of behavioral approaches. Other methods include utilizing topical anesthetics prior to the injection, applying lignocaine patches to the gingiva, using electronic dental anesthetic, or using computerized equipment like the Wand to alleviate discomfort.

The purpose of this randomized controlled trial is to compare and evaluate the effect of transcutaneous electric nerve stimulation (TENS) and Photobiostimulation using diode laser in reducing pain and anxiety prior to administration of local anesthesia and the effect on duration of onset of local anesthesia in Paediatric patients

研究设计

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

入排标准

年龄范围
12.00 Year(s) 至 16.00 Year(s)(—)
性别
All

入选标准

  • 1 Patient in ASA-I and ASA-II category.
  • 2 Patients who are undergoing bilateral orthodontic extractions of vital teeth 3 Potentially cooperative patients.

排除标准

  • Patients who have dental caries, infection, trauma.
  • Patients with central nervous system disorders, congenital heart diseases and pacemakers.
  • Patient with known allergy to any component of local anaesthesia, electrode/tape/gel.
  • Allergy to light(photosensitivity)
  • Patients with skin conditions (eczema, dermatitis)
  • Patients with open wounds or current or recent bleeding.
  • Patient unwilling to be part of this study.

结局指标

主要结局

Anxiety levels will be measured using- Salivary alpha amylase level, salivary pH ,Pulse rate FLACC SCORE FOR PAIN

时间窗: Baseline | Pre Operative | Post Operative

次要结局

  • level of pain using FLACC pain score, Salivary alpha amylase, Salivary pH and Pulse rate(Baseline)

研究者

发起方
ITS Dental college hospital and research centre
申办方类型
Other [Dental College hospital and research centre]

研究点 (1)

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