Pain Perception During Inferior Alveolar Nerve Block Administration in Children Using Vibraject and Dental Vibe Versus Conventional Syringe

Официальное название

Pain Perception During Inferior Alveolar Nerve Block Administration in Children Using Vibraject and Dental Vibe Versus Conventional Syringe: A Randomized Controlled Clinical Trial

Обзор

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.

Подробное описание

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.

The Findings of this study aims to provide evidence-based guidance on the optimal non pharmacological technique to enhance pain-controlled dental procedures allowing better quality of dental treatment and Improve the patient's cooperation and acceptance for future dental visits.

Вмешательства

• Устройство Vibraject
  Familiarize the child with the Vibraject device, allowing them to feel the vibrations on their hand to reduce anxiety. Dry the injection site with sterile gauze. Apply 20% benzocaine gel for 1 minute using a cotton swab. Use a conventional syringe with the Vibraject attachment, 4% articaine (1:100,000 epi), and a 27-gauge long needle. Deliver an inferior alveolar and lingual nerve block. Slowly deposit 1.5 mL of anesthetic over at least 60 seconds to minimize discomfort. Use the FLACC scale
• Устройство Dental vibe
  Familiarize the child with the DentalVibe device, letting them feel the vibrations on the back of their hand. Dry the mucosa with gauze and apply 20% benzocaine gel for 1 minute. Apply the DentalVibe to the buccal mucosa for pre-injection vibration. Using a conventional syringe (4% articaine, 1:100,000 epi, 27G needle), perform the mandibular block simultaneously while the DentalVibe is active. Slowly deposit 1.5 mL (1.0 mL alveolar / 0.5 mL lingual) over at least 60 seconds. Evaluate pain us
• Устройство Conventional syringe
  Dry the injection site with sterile gauze. Apply 20% benzocaine gel for 1 minute using a cotton swab to ensure surface numbing. Use a conventional metal aspirating syringe with 4% articaine (1:100,000 epi) and a 27-gauge long needle. Deliver a mandibular inferior alveolar nerve block. Slowly deposit 1.5 mL total (1.0 mL for the alveolar nerve and 0.5 mL for the lingual nerve) over a minimum of 60 seconds. Evaluate pain using the FLACC scale (during) and the Wong-Baker FACES scale (after). Re

Первичные конечные точки

• Subjective pain during injection [Срок оценки: during injection]

Вторичные конечные точки (1)

• Objective pain during injection [Срок оценки: Baseline and during injection]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of Dentistry,Cairo University — Cairo

Идентификаторы

NCT: NCT07571278 · anesthesia technique-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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