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临床试验/CTRI/2024/03/063752
CTRI/2024/03/063752已完成4 期

Comparative Evaluation Of Dental Anxiety & Fear In Children By Using Star Pen-dental Anaesthesia Device, Vibrajet, Insulin Syringe And Camouflaged LA Syringe During Local Anaesthesia Administration

Dr Madhuri Bhandare1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年3月12日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
To evaluate dental anxiety & fear in children by using star pen-dental anaesthesia device, vibrajet, insulin syringe and camouflaged l.a syringe during local anaesthesia administration

研究概览

简要总结

INTRODUCTION:-

Dental fear and anxiety is one of the major challenges in pediatric dentistry . DFA is a common reason for avoiding dental treatment, which over time, may result in deteriorated oral health. Some children find it difficult to cope with the stimuli and behavioral demands associated with dental experience. This could be due to fear of the needle, bodily harm, or a general fear of the unknown. Successful treatment of pediatric patients, in terms of allaying their anxiety and discomfort during restorative and surgical procedures, is facilitated by  profound local anesthesia

In order to overcome this, many advanced injection techniques have been implemented. The most recent and advanced technique was using a Starpen-local anaesthetic device .and VibraJet-small  vibrating device to deliver dental anaesthesia.

METHODOLOGY-

Patient who satisfied the inclusion and exclusion criteria will be randomly divided into four groups consisting 10 patients each i.e. Group 1- Starpen –dental anaesthesia device , Group 2 – VibraJet –dental anaesthesia device, Group 3- Insulin Syringe and Group 4- Camouflaged L.A syringe ,Local anesthetic (LOX × 2% adrenaline) is delivered according to assigned group in the area adjacent to the tooth requiring invasive treatment procedure.

Preoperative evaluation will be done before local anaesthesia admininistration by recording pulse rate and Venhams Picture Test which comprices 8 cards with 2 picture in each card one anxious  and one non anxious. The score ranges from  0 to 8 maximum score . Facial Image Scale - A subjective scale used to assess pain- A set of six cartoon faces will be shown to the child with varying facial expressions ranging from a very smiling face to a very sad face. A brief explanation will be given to the child about each face after which the child was instructed to choose the face that best described his/ her feelings before and after local anesthesia-Scores from 1 to 4.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

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

入选标准

  • Children having their first dental visit Healthy children with no systemic illness, allergies, etc.
  • Cooperative child.
  • Patient requiring local anesthetic injection for dental treatment either in maxillary or mandibular arch.
  • Children with proper parental consent.

排除标准

  • Children with emergency treatment needs, such as abscess, cellulitis and space infection, and those who needed premedication for receiving dental treatment.
  • Medically compromised patient Children with behavioural management problem Children allergic to local anesthetic agents.
  • Children below 6 years of age.

结局指标

主要结局

To evaluate dental anxiety & fear in children by using star pen-dental anaesthesia device, vibrajet, insulin syringe and camouflaged l.a syringe during local anaesthesia administration

时间窗: At the time before and after local anaesthesia | delivery prior treatment

次要结局

  • To compare dental anxiety & fear in children by using star pen-dental anaesthesia device,
  • To compare dental anxiety & fear in children by using Vibrajey(At the time before & after local anaesthesia)
  • To compare dental anxiety & fear in children by using Insulin syringe(At the time before & after local anaesthesia)
  • To compare dental anxiety & fear in children by using camouflaged syringe(At the time before & after local anaesthesia delivery prior treatment)

研究者

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

Dr Madhuri Bavaji Bhandare

jawahar medical foundation annasaheb chudaman patil memorial dental college

研究点 (1)

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