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临床试验/NCT06001710
NCT06001710已完成不适用

Assessment of Needleless Jet Injection in Pain and Anxiety Management During Vital Pulpotomy of Primary Molars

Suez Canal University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Venham's anxiety and behavioral rating scale

研究概览

简要总结

To evaluate and compare the efficiency of needleless jet injection versus traditional inferior alveolar nerve block anesthesia in management of pain and anxiety during vital pulpotomy of lower second primary molars using Wong-Baker FACES Pain Rating Scale and Venham's anxiety and behavioral rating scale..

详细描述

One of the most effective ways to control pain during invasive dental procedures is the use of local anesthesia which considers the most painful phase of treatment. The idea of receiving an injection is fear-inducing for many individuals, both children and adults which can lead patients to avoid dental treatments. Although such fears are outside the control of dentists, some treatment aspects can be modified to increase patient comfort.(1)

Dental care may be associated with pain which may be intertwined with fear and anxiety, especially among children with treatment needs. The pain intensity is multiplied by having higher dental anxiety, a disability, age less than 14 years old and gender (female). The young patient's pain expectations may also add to the situational complexity. Consequently, dental health care may be perceived as insurmountable problem. (2) Administrating an anesthetic agent with a traditional syringe causes discomfort during the puncture and injection stages. (3) Incorrect handling of the syringe is a determining factor for pain (4), which is exacerbated due to excessive pressure on the plunger and rapid injection of large volumes of anesthetic solution.(5)

To minimize the painful sensation during local anesthesia, other methods can be adopted, such as applying topical anesthetics prior to injection (6), using computerized injection systems, and using needleless jet injection systems (7). A needleless system includes a spring coupled to an apparatus that generates sufficient Pressure to (8) push the plunger of the ampoule (9)and makes the anesthetic solution pass through a micro orifice at high speed.

The absence of a needle in a jet injection can result in a more comfortable experience, as this eliminates the puncture and injection phases, which are considered the most painful steps during traditional anesthesia (3). This difference is important as approximately one in five adults have phobia of dental anesthesia due to fear of injections, which leads to interruption of dental treatment (10).

Since there are no studies about the efficacy of needleless jet injection systems during pulpotomy of lower second primary molars, the aim of this clinical trial was to evaluate and compare the efficiency of needleless jet injection versus traditional inferior alveolar nerve block anesthesia in management of pain and anxiety during vital pulpotomy of lower second primary molars

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
4 Years 至 8 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Apparently healthy children.
  • •Children aged from 4-8 years old.
  • •Both boys and girls were included
  • •Children scored (2 or 3) Frankle behavior rating scale.
  • •Children had bilateral deep carious lower second primary molars indicated clinically and radiographically for vital pulpotomy
  • •Informed consent was included from parents or caregivers.

排除标准

  • •Children with evidence of allergy to any materials used in this study
  • •Clinical criteria:
  • •Clinical history of spontaneous pain, intra-oral facial swelling or presence of fistula or sinus tract.
  • •Tooth with irreversible pulpitis, determined as continuous bleeding exceeding 5 minutes, dark to purple blood color or pulp necrosis.
  • •Radiographic criteria:
  • •Presence of any signs of internal or external root resorption, furcation radiolucency or periapical pathosis as revealed by preoperative periapical radiography.

研究组 & 干预措施

classic inferior alveolar nerve block anesthesia

Active Comparator

Inferior alveolar nerve block (IANB) is a technique of dental anesthesia, used to produce anesthesia of the mandibular teeth, gingivae of the mandible and lower lip. The conventional IANB is the most commonly used the nerve block technique for achieving local anesthesia for mandibular surgical procedures using long needle

干预措施: Needleless jet injector (Device)

needleless jet injector anesthesia

Experimental

Jet injection technology uses mechanical energy to force a liquid drug into subcutaneous tissues without a needle using infiltration technique

干预措施: Needleless jet injector (Device)

结局指标

主要结局

Venham's anxiety and behavioral rating scale

时间窗: After local anesthesia and during pulpotomy

assess the anxiety and uncooperative behavior of children in the dental setting.consist of five behavioral defined categories ranging from 0 to 5 with higher score, indicating greater level of anxiety or lack of cooperation.

Wong-Baker FACES Pain Rating Scale

时间窗: After local anesthesia and during pulpotomy

a method for someone to self-assess and effectively communicate the severity of pain they may be experiencing. The scale contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts"

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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