Pain Perception During Inferior Alveolar Nerve Block Administration in Children Using Vibraject and Dental Vibe Versus Conventional Syringe: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Subjective pain during injection
研究概览
简要总结
This RCT study aims to establish evidence based decision comparing between Vibraject (MiltexInc LLC.,York,PA,USA).and Dental vibe(BING Innovations LLC,Crystal Lake,IL,USA versus Conventional Syringe on pain perception during inferior alveolar nerve block anesthesia in lower primary molars indicated for extraction,pulp therapy and cavity preparation in Children.
详细描述
This randomized controlled clinical trial aims to compare pain perception of Vibraject and dental vibe during inferior alveolar nerve block in lower primary molars indiacted for extraction,pulp therapy and cavity preparation in children aged 6-8 years.
Pain during local anesthesia remains a major concern in pediatric dentistry, as it contributes significantly to fear, anxiety, and uncooperative behavior in children. Vibration devices, based on the gate control theory of pain, have been introduced as a non-pharmacological method to reduce injection discomfort.
Ninety children will be randomly allocated into 3 parallel groups(1:1:1): Inferior alveolar nerve block Injection using Vibraject system,Inferior alveolar nerve block Injection using Dentalvibe system, Inferior alveolar nerve block Injection using the Conventional Syringe.
All participants will undergo standardized procedures, including topical anesthesia application followed by local anesthetic injection using articaine. Pain perception during injection will be assessed using both subjective and objective measures.
The primary outcome is subjective pain perception during injection measured using Wong-Baker Scale,While secondary outcome is objective pain perception during injection measured using FLACC Scale,Finally The Physiological parameters(heart rate, oxygen saturation )will be measured at two time points: baseline and during injection using pulse oximeter device on child's index finger.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The blinding of operator is not possible due to the nature of the anaesthesic procedure.
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 6-8 years.
- •Cooperative children (Rating 3 or 4 based on the Frankl behaviour scale).
- •Medically fit children (ASA I).
- •Children mentally capable of communication.
- •First dental visit (no previous history of injection of LA).
- •Patient requiring extraction/pulp therapy/cavity preparation in mandibular primary molars
排除标准
- •Uncooperative patient (other than 3 or 4 based on the Frankl behaviour scale).
- •Medically unfit children (other than ASA 1).
- •Parental refusal of participation.
- •Children under medications (antibiotics and analgesics) for the previous 48 hours that could alter the pain perception.
- •Children who are allergic to local anaesthesia.
研究组 & 干预措施
Inferior alveolar nerve block Injection using Vibraject system(MiltexInc LLC.,York,PA,USA).
VibraJect is a compact, battery-operated unit that attaches directly to a standard dental syringe, generating high-frequency vibrations along the needle to attenuate pain during anesthetic delivery. If these devices prove efficacy, they may offer a rapid, non-pharmacologic method to enhance the comfort of children undergoing local anesthesia.
干预措施: Vibraject (Device)
Inferior alveolar nerve block Injection using Dentalvibe system (BING Innovations LLC,Crystal La).
The DentalVibe device is a cordless, rechargeable instrument that produces controlled, pulsed micro-vibrations at the injection site. It features a U-shaped vibrating tip connected to a microprocessor-driven VibraPulse motor, allowing gentle stimulation of sensory receptors, illumination of the injection area, and retraction of the cheek or lip.
干预措施: Dental vibe (Device)
Inferior alveolar nerve block Injection using the Conventional Syringe.
A conventional metal aspirating syringe
干预措施: Conventional syringe (Device)
结局指标
主要结局
Subjective pain during injection
时间窗: during injection
Wong-Baker Scale: represents a series of faces from a 0-value happy face (which represents lack of pain) to a 10-value crying face (which suggests the worst possible pain). On this basis, the patient chooses the face that best describes his/her level of pain.
次要结局
- Objective pain during injection(Baseline and during injection)
研究者
Yasmeen Mohamed Hussein Mohamed Amer
Principal Investigator
Cairo University