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临床试验/CTRI/2024/11/077488
CTRI/2024/11/077488尚未招募4 期

Anesthetic effectiveness of trans-papillary injection and conventional palatal injection technique in children of age 7-10 year – A randomized controlled trial

Dr Arun CS1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年12月12日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Accessing pain experienced during administration and after extraction of the tooth by FAS and VAS scales

研究概览

简要总结

The buccal mucosa will be wiped and dried with sterile dry cotton followed by application of 20% benzocaine topical gel (SEPTODONT PROGEL-B) with the help of Q tip. After 10 seconds patient will be injected with 2% lignocaine hydrochloride with 1:200000 adrenaline with a help of 27G needle of 15mm length. A 2ml syringe will be used for both the techniques. Then 1.0 ml of solution will be injected into the buccal sulcus after which 0.5ml of anesthetic solution will be injected in the inter papillary region or the palatal region depending up on the technique used. Anxiety level is assessed before the procedure by assessing, pulse rate(P.R), oxygen saturation(spO2) with the help of pulse oximeter while questionnaire will be administer through interview to assess anxiety.  Immediately after the LA administration, pain will be assessed in both the techniques by Visual Analogue Scale (VAS) and WONG- BAKER PAIN SCALE(FPS). After objective and subjective evaluation, and confirming that the patient is anesthetized, extraction will be done. The pain will be evaluated in immediate post extraction time by using the VAS and FAS scale. Post extraction anxiety level of child will be assessed using, pulse rate (P.R), oxygen

saturation (spO2) with the help of pulse oximeter, and questionnaire will be administered through interview. The collected data will be entered in MS excel and the statistical analysis will be done using the software, Statistical Package for the Social Sciences. One of the common reason for developing dental fear and anxiety among children is the past painful experience by the patient during dental extraction. Trans-papillary injection is one of the alternative techniques by which the patient can be administered local anesthesia comparatively in a less painful way and increase overall experience of tooth extraction and help in decreasing dental fear and anxiety which lead to more frequent dental clinic visit and in turn increase the oral health related quality of life.

研究设计

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

入排标准

年龄范围
7.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Children who needs primary maxillary molar extraction.
  • Children under ASA I and II category.

排除标准

  • Children who reported with allergy or hypersensitivity to local anesthetics or any ingredients in anesthetic solution.
  • Children under CNS depressants.
  • Children not willing to participate in the study.

结局指标

主要结局

Accessing pain experienced during administration and after extraction of the tooth by FAS and VAS scales

时间窗: At baseline, immediately after local anesthetic administration and post-extraction of the tooth.

次要结局

  • Assessing anxiety via QUESTIONNAIRE, PULSE RATE, & SpO2 after the extraction of the tooth by conventional palatal technique(At baseline, before & after extraction period)
  • Assessing anxiety via QUESTIONNAIRE, PULSE RATE, & SpO2 after the extraction of the tooth by trans-papillary injection technique.(At baseline, before & after extraction period)
  • Comparison of anxiety between conventional palatal technique & trans-papillary injection technique.(At baseline, before & after extraction period)

研究者

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

Dr Arun CS

Government Dental College, Kottayam

研究点 (1)

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