Different Local Anesthesia Techniques for Mandibular Primary Molar Pulpectomy

Официальное название

Comparison of Computer-Controlled and Conventional Local Anesthesia Techniques on Dental Anxiety and Pain During Mandibular Primary Molar Pulpectomy: A Split-Mouth Randomized Clinical Trial

Обзор

This study aims to compare the effects of computer-controlled local anesthesia and conventional inferior alveolar nerve block on dental anxiety and pain in children undergoing pulpectomy of mandibular primary molars. Both anesthesia techniques are routinely used in pediatric dental practice and are considered standard methods of care. Children aged 6 to 8 years who require bilateral pulpectomy of mandibular primary molars will be included in this split-mouth randomized clinical trial. Each participant will receive both anesthesia techniques during separate treatment sessions. Dental anxiety, pain, and physiological parameters, including heart rate, blood pressure, oxygen saturation, and body temperature, will be assessed before, during, and after treatment using validated pediatric assessment scales and routine clinical measurements. The findings of this study may help identify the anesthesia technique that provides greater comfort and reduces anxiety and pain during pediatric dental treatment, thereby improving the overall treatment experience for children.

Вмешательства

• Процедура Computer-Controlled Local Anesthesia
  Computer-controlled delivery of local anesthetic for mandibular primary molar pulpectomy.
• Процедура Conventional Inferior Alveolar Nerve Block
  Conventional inferior alveolar nerve block administered with a standard dental syringe for mandibular primary molar pulpectomy.
• Препарат Articaine hydrochloride with epinephrine 1:100,000
  A 4% articaine hydrochloride solution with epinephrine 1:100,000 was used as the local anesthetic solution in both study groups.
• Устройство Computer-Controlled Local Anesthetic Delivery System
  A computer-controlled local anesthetic delivery device was used to deliver the anesthetic solution at a constant, pre-programmed injection rate.
• Устройство Standard Dental Aspirating Syringe
  A conventional dental aspirating syringe was used for manual administration of the local anesthetic solution.

Первичные конечные точки

• Dental Anxiety [Срок оценки: Baseline and immediately after treatment]
• Behavioral Pain During Local Anesthesia [Срок оценки: Immediately after local anesthetic injection]

Вторичные конечные точки (6)

• Self-reported Pain [Срок оценки: Immediately after local anesthetic injection]
• Facial Image Scale (FIS) Score [Срок оценки: Baseline and immediately after treatment.]
• Heart Rate [Срок оценки: Baseline and during local anesthetic administration]
• Blood Pressure [Срок оценки: Baseline, during local anesthetic administration, and immediately after treatment]
• Peripheral Oxygen Saturation (SpO₂) [Срок оценки: Baseline, during local anesthetic administration, and immediately after treatment]
• Body Temperature [Срок оценки: Baseline, during local anesthetic administration, and immediately after treatment]

Критерии участия

Критерии включения

• Children aged 6 to 8 years.
• Requiring bilateral pulpectomy treatment of mandibular primary molars.
• Frankl Behavior Rating Scale score of 3 or 4.
• American Society of Anesthesiologists (ASA) Physical Status I.
• No known allergy to local anesthetic agents.
• No previous experience with dental local anesthesia.
• No signs of acute abscess or swelling in the treatment area.
• Parent or legal guardian able to provide written informed consent and child willing to participate.

Критерии исключения

• ASA Physical Status II or higher.
• Known allergy or contraindication to local anesthetic agents.
• Frankl Behavior Rating Scale score of 1 or 2.
• Children receiving psychological or psychiatric treatment.
• Physical or intellectual disabilities that could interfere with study procedures.
• Previous experience with dental local anesthesia.
• Presence of acute abscess, cellulitis, or diffuse swelling in the treatment area.

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

• Recep Tayyip Erdoğan University — Merkez

Идентификаторы

NCT: NCT07714915 · 2026/268

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗