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Набор скоро начнётся NCT07748390

Pain and Anxiety During Vital Pulp Therapy Using Different Local Anesthesia Techniques in Children

— Наблюдательное Pediatric Anesthesia

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Pediatric, Anesthesia. Базовые параметры: 8 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Evaluation of the Effects of Different Local Anesthesia Techniques on Dental Anxiety and Pain During Vital Pulp Therapy

Обзор

This prospective observational study aims to evaluate the effects of different local anesthesia techniques on dental anxiety and pain in children undergoing vital pulp therapy of permanent mandibular first molars. Conventional inferior alveolar nerve block and two computer-controlled local anesthetic delivery (CCLAD) systems used in routine clinical practice will be compared. The choice of anesthesia technique will be based on the clinician's routine decision-making, and no additional intervention or modification of standard treatment will be performed for research purposes. Dental anxiety, pain, physiological parameters, and postoperative complications will be assessed using validated clinical scales and routine clinical measurements. The findings may help improve pain and anxiety management during pediatric dental treatment while supporting evidence-based selection of local anesthesia techniques.

Первичные конечные точки

  • Pain Response During Local Anesthesia Administration [Срок оценки: During local anesthesia administration]
Вторичные конечные точки (8)
  • Dental Anxiety Level Assessed by the Modified Child Dental Anxiety Scale-Faces Version (MCDASf) [Срок оценки: Baseline (before treatment) and immediately after completion of treatment]
  • Immediate Emotional Status Assessed by the Facial Image Scale (FIS) [Срок оценки: Before anesthesia administration and after local anesthesia administration]
  • Post-Treatment Pain Intensity Assessed by the Wong-Baker Faces Pain Rating Scale [Срок оценки: Immediately after completion of treatment]
  • Heart Rate [Срок оценки: Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment]
  • Postoperative Complications After Vital Pulp Therapy [Срок оценки: 24 hours after treatment]
  • Blood Pressure [Срок оценки: Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment]
  • Peripheral Oxygen Saturation (SpO₂) [Срок оценки: Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment]
  • Body Temperature [Срок оценки: Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment]

Критерии участия

Критерии включения

  • Children aged 8-10 years.
  • Children and parents/legal guardians who agree to participate in the study and provide informed consent.
  • Patients requiring vital pulp therapy of a permanent mandibular first molar.
  • Patients classified as Frankl Behavior Rating Scale score 3 or 4. Systemically healthy children (ASA I).
  • Children with adequate cognitive and communication abilities to understand the study procedures and pain/anxiety assessment scales.
  • Permanent mandibular first molars without clinical or radiographic signs of abscess, fistula, or periapical pathology.

Критерии исключения

  • Children with systemic diseases or medical conditions affecting dental treatment.
  • Children classified as Frankl Behavior Rating Scale score 1 or 2.
  • Patients with known allergy or hypersensitivity to local anesthetic agents (e.g., lidocaine, articaine).
  • Teeth with acute dental infection signs, including abscess, cellulitis, or extensive infection.
  • Teeth showing clinical or radiographic evidence of periapical pathology.
  • Children unable to understand or complete pain and anxiety assessment scales due to cognitive, visual, hearing, or communication limitations.
  • Patients who do not comply with the study procedures or withdraw consent.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07748390 · 2026/319

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗