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Идёт набор NCT07101068

Assessment of Pain and Anxiety During Infiltration Anesthesia Using Dental Anesthesia Injector Versus Conventional Syringe in Pediatric Patients

Без фазы С лечением Dental Caries Reversible Pulpitis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Dental Anesthesia Injector, conventional syringe.
Кому может быть актуально
Состояния в реестре: Dental Caries, Reversible Pulpitis. Базовые параметры: 6 лет — 8 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
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Официальное название

A Randomized Clinical Trial to Assess Pain and Anxiety During Infiltration Anesthesia Using Dental Anesthesia Injector Versus Conventional Syringe in Pediatric Patients

Обзор

This randomized controlled trial is conducted on pediatric dental patients to compare the effectiveness of local anesthesia administered using a dental anesthesia injector device versus the traditional syringe method. The study aims to assess and compare pain and anxiety levels associated with both methods, using both subjective (self-reported) and objective measures. The goal is to identify an alternative technique that minimizes pain and anxiety in pediatric dental patients.

Подробное описание

This randomized controlled split-mouth clinical trial aims to assess pain and anxiety in pediatric dental patients during and immediately after the administration of local anesthesia using a dental anesthesia injector device compared to a conventional syringe.

The study will include healthy, cooperative children aged 6 to 8 years, each having at least one vital deeply carious maxillary primary molar with signs and symptoms of reversible pulpitis on each side of the maxilla requiring buccal infiltration anesthesia prior to pulpotomy.

Each child will receive both injection techniques on separate occasions, with random assignment of the injection method to either the right or left side (split-mouth design).

To evaluate pain and anxiety, the following tools will be used:

Pain: Visual Analogue Scale (VAS) Anxiety: Corah Dental Anxiety Scale Physiological measures: Heart rate and oxygen saturation levels, recorded using a pulse oximeter Data will be collected during and immediately after the injection. The aim is to determine whether the dental anesthesia injector provides a less painful and less anxiety-inducing experience compared to the traditional syringe method.

Вмешательства

  • Устройство Dental Anesthesia Injector
    Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using Dental Anesthesia Injector.
  • Другое conventional syringe
    Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using conventional syringe

Первичные конечные точки

  • Pain during injection [Срок оценки: The pain felt by patient will be assessed by Visual analogue scale, Pulse rate and Oxygen saturation at day 1 of anesthesia injection.]
  • Anxiety felt by the patient [Срок оценки: the scale will be used at day 1 of anesthesia injection]
Вторичные конечные точки (1)
  • Need for additional anesthesia [Срок оценки: The assessment will be done during dental visit at day 1 of anesthesia injection]

Критерии участия

Критерии включения

  • normal healthy patients (ASA I)
  • Undergoing the first dental local anesthesia experience
  • Presence of one at least vital deeply carious maxillary primary molar indicated for pulpotomy on each side of maxilla
  • Score 3 or 4 of Frankl scale of child behavior

Критерии исключения

  • Presence of gingivitis, dental abscess, facial trauma/ injury
  • Administration of analgesic 48 h before randomization
  • Presence of allergy from local anesthesia

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Тройное слепое
Основная цель
Другое

Центры проведения

Египет · 2 центра
  • Ain Shams University — Cairo
  • Faculty of dentistry, Ain Shams University — Cairo

Публикации

  • Vitale MC, Gallo S, Pascadopoli M, Alcozer R, Ciuffreda C, Scribante A. Local anesthesia with SleeperOne S4 computerized device vs traditional syringe and perceived pain in pediatric patients: a randomized clinical trial. J Clin Pediatr Dent. 2023 Jan;47(1):82-90. doi: 10.22514/jocpd.2023.002. Epub 2023 Jan 3. PMID 36627224

Идентификаторы

NCT: NCT07101068 · FDSU-Rec IMO12441

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗