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Идёт набор NCT07095946

Effectiveness of Intraligament vs IANB Anesthesia in Children Using Electronic Syringe

Без фазы С лечением Effectiveness of Anesthesia Using Electronic Syringe in Children in the Context of Endotopy Treatment

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: Electronic Syringe Intraligament Technique, Electronic syringe IANB Technique.
Кому может быть актуально
Состояния в реестре: Effectiveness of Anesthesia Using Electronic Syringe in Children in the Context of Endotopy Treatment. Базовые параметры: 6 лет — 10 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
Syria
Следующий шаг
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Официальное название

Comparing the Effectiveness of the Intraligament Anesthesia Technique With the Inferior Alveolar Nerve Block Technique Using the Electronic Syringe in Children: A Random Clinical Study

Обзор

This randomized clinical study aims to evaluate the efficacy and pain response of two local anesthesia techniques in pediatric dental treatment using an electronic syringe: ligament anesthesia and inferior alveolar nerve block (IANB). The study applies both techniques to the same sample, where each child undergoes pulpectomy for two different teeth, each under the influence of a different anesthesia technique, during two separate visits. This study comes in the context of technological advancements in dentistry, which led to the development of computerized syringes as an alternative to traditional syringes. These devices are characterized by precise control of the anesthetic flow rate, as well as containing musical and auditory systems aimed at distracting the child and reducing feelings of fear and anxiety associated with dental treatment. Additionally, computerized syringes provide audible indicators showing the amount of anesthetic injected and support multiple injection modes such as rapid injection, slow injection, and ligament injection, allowing for more efficient and comfortable anesthetic delivery. Pain intensity will be assessed during three stages of the treatment procedure: during anesthesia administration, during placement of the rubber dam, and during opening of the pulp chambers. Post-procedure pain will also be evaluated using an age-appropriate validated pain scale, along with assessing the satisfaction level of both the children and their parents regarding the use of the electronic syringe as an alternative anesthesia tool. These combined measures aim to provide a comprehensive understanding of the child's experience during dental treatment and contribute to improving anesthesia practices in pediatric dentistry.

Вмешательства

  • Устройство Electronic Syringe Intraligament Technique
    Use of an electronic syringe device to deliver local anesthesia using the periodontal ligament (PDL) technique in pediatric dental patients
  • Устройство Electronic syringe IANB Technique
    Use of an electronic syringe device to deliver local anesthesia via the Inferior Alveolar Nerve Block Technique in pediatric dental patients

Первичные конечные точки

  • Success rate of electronic syringe anesthesia in pediatric dental procedures [Срок оценки: During procedure (From the start of ligation anesthesia (30 seconds) and block anesthesia (3 to 5 minutes) until reaching the stage of pulp chamber opening)]
  • Success rate of anesthesia technique [Срок оценки: During procedure (From the start of ligation anesthesia (30 seconds) and block anesthesia (3 to 5 minutes) until reaching the stage of pulp chamber opening.)]

Критерии участия

Критерии включения

  • Cooperative children based on Frankl Behavior Rating Scale (Positive or Definitely Positive)
  • No clinical signs or symptoms indicating irreversible pulpitis
  • No periodontal ligament inflammation of the tooth to be treated
  • Children aged between 5 and 9 years
  • Children without systemic health problems

Критерии исключения

  • Children who are uncooperative based on Frankl Behavior Rating Scale (Negative or Definitely Negative)
  • Presence of spontaneous or nocturnal pain
  • Clinical signs and symptoms indicating irreversible pulpitis
  • Presence of periodontal ligament inflammation of the treated tooth
  • Child age older than 10 years or younger than 3 years
  • Children with systemic health problems

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
Открытое
Основная цель
Лечение

Центры проведения

Syria · 1 центр
  • Faculty of Pediatric Dentistry, Tishreen University — Latakia

Идентификаторы

NCT: NCT07095946 · PED-DENT-Tishreen-University

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗