Comparison of Digital Intraosseous and Manual Intraligamentary Anesthesia in Children

Официальное название

Comparison of Digital Intraosseous and Manual Intraligamentary Anesthesia in Children: A Randomized Controlled Trial

Обзор

The aim of this study is to compare the effects of digital intraosseous anesthesia and manual intraligamentary anesthesia techniques on pain scores during the restorative treatment of permanent mandibular molars in pediatric patients. In addition, the techniques will be compared in terms of injection pain, anesthetic success, postoperative complications, and patient preferences. This randomized, controlled, crossover, single-blind, split-mouth study will be conducted on 78 children aged 6-12 years. Participants with bilateral permanent mandibular molars presenting enamel-dentin carious lesions will be included in the study.

Подробное описание

Participants who meet the eligibility criteria will be allocated into two study arms according to age, sex, dental experience, DMFT/dmft scores, ICDAS II classification, and radiographic findings. Each participant will receive two different anesthesia techniques-digital intraosseous anesthesia and manual intraligamentary anesthesia-applied to the right and left permanent first mandibular molars with a one-week washout period between visits.

The study population will be divided into two sequence groups. In Group 1 (n = 39), intraligamentary anesthesia will be administered during the first visit, followed by digital intraosseous anesthesia in the second visit. In Group 2 (n = 39), the sequence will be reversed, with digital intraosseous anesthesia administered first and intraligamentary anesthesia administered during the second visit.

Pain perception during both the injection phase and the restorative procedure will be subjectively assessed using the Visual Analog Scale (VAS) and the Wong-Baker FACES Pain Rating Scale. Physiological parameters, including heart rate and arterial oxygen saturation, will be monitored and recorded. Anesthetic quality and success will be evaluated at the end of each visit based on the clinical outcomes of the restorative procedure.

Following each anesthesia administration, participants will be informed of potential complications, including allergic reactions, a sensation of tooth elevation, or postoperative sensitivity related to the restoration. They will be instructed to document any complications encountered. Postoperative complications will be collected by contacting participants one day after both the first and second visits. At the end of the second visit, each participant's preferred anesthesia technique will also be recorded.

Вмешательства

• Процедура Intraligamentary anaesthesia
  Anesthesia One tooth anaesthesia by 2 or 4 points intraligamentary injection
• Процедура Digital Intraosseous Anesthesia
  Anesthesia for one tooth using computer-controlled single-point injection into cancellous bone

Первичные конечные точки

• Pain intensity using Visual Analog Scale (VAS) [Срок оценки: During injection and during dental procedure]
• Pain intensity using Wong-Baker FACES Pain Rating Scale [Срок оценки: During injection and during dental procedure]
• Heart rate changes [Срок оценки: Baseline, during injection and during dental procedure]
• Oxygen saturation (SpO₂) changes [Срок оценки: Baseline, during injection and during dental procedure]
• Practitioner's assessment of anesthesia success [Срок оценки: Immediately after dental treatment]
• Postoperative complications [Срок оценки: Day 1 after intervention]

Вторичные конечные точки (1)

• Correlation between pain scores measured by VAS and Wong-Baker FACES scale [Срок оценки: Immediately after injection]

Критерии участия

Критерии включения

• Subjects with American Society of Anesthesiologists score I (ASA I)
• Subjects with Frankl's behavior rate III (positive) and IV (definitely positive),
• Subjects with indication of similar restoration treatment on bilateral first -permanent mandibular molars
• Subjects whose plaque index score of 0 (no plaque) and 1
• Subjects whose gingival index score of 0

Критерии исключения

• Allergic to the local anesthetics or sulfites
• Subjects with cholinesterase deficiency
• Subjects who use drugs that may affect the assessment of pain, such as narcotic or non-narcotic analgesic, anti-inflammatory, anxiolytic, antipsychotic and antihistamine agents
• Subjects who need to use sedatives or other medications during dental procedures

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

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Izmir Katip Çelebi University Faculty of Dentistry — Izmir

Идентификаторы

NCT: NCT07524569 · 2025/75

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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