Comparison of Computer-Assisted and Conventional Local Anesthesia in Children With Molar-Incisor Hypomineralization

Официальное название

Comparison of Computer-Assisted and Conventional Local Anesthesia in Children With Molar-Incisor Hypomineralization: A Split-Mouth Randomized Controlled Clinical Trial

Обзор

The main questions this study aims to answer are: Does computer-controlled local anesthesia cause less pain and anxiety than conventional local anesthesia in children with molar-incisor hypomineralization (MIH)? Is there a difference between the two methods in anesthesia onset time, injection duration, physiological responses, and the need for additional anesthesia? Researchers will compare computer-controlled and conventional local anesthesia in children aged 8-12 years with MIH. Each child will receive both anesthesia methods during separate dental visits, on comparable permanent molar teeth, to determine which method is more comfortable, effective, and preferred by children.

Подробное описание

This randomized split-mouth clinical trial will compare computer-controlled local anesthesia with conventional local anesthesia in children aged 8-12 years with molar-incisor hypomineralization (MIH).

Each child will receive both anesthesia methods during separate restorative treatment visits on comparable affected permanent molars. Pain will be evaluated using child-reported and behavioral pain scales. Dental anxiety, heart rate, oxygen saturation, anesthesia onset time, injection duration, need for additional anesthesia, and patient preference will also be assessed.

The study aims to determine whether computer-controlled local anesthesia provides a more comfortable and effective option than conventional anesthesia for children with MIH.

Вмешательства

• Устройство Computer-Controlled Local Anesthesia
  Local anesthesia will be administered using the SleeperOne computer-controlled local anesthetic delivery system according to the manufacturer's pediatric protocol. The device electronically controls the flow rate and pressure of the anesthetic solution. A 4% articaine solution with 1:100,000 epinephrine will be administered before restorative treatment of the MIH-affected permanent molar.
• Процедура Conventional Local Anesthesia
  Local anesthesia will be administered using a conventional dental syringe. Buccal infiltration will be used for maxillary teeth, and an inferior alveolar nerve block will be used for mandibular teeth. A 4% articaine solution with 1:100,000 epinephrine will be administered before restorative treatment of the MIH-affected permanent molar.

Первичные конечные точки

• Injection pain assessed using the Wong-Baker Faces Pain Rating Scale [Срок оценки: Immediately after completion of local anesthetic injection at each treatment visit]
• Injection pain assessed using the Visual Analog Scale (VAS) [Срок оценки: Immediately after completion of local anesthetic injection at each treatment visit]
• Behavioral pain assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale [Срок оценки: Periprocedural (during local anesthetic injection at each treatment visit)]
• Successful local anesthesia during restorative treatment [Срок оценки: Immediately after completion of restorative treatment at each treatment visit]
• Absence of response to electric pulp testing [Срок оценки: Immediately after completion of local anesthetic injection at each treatment visit]
• Anesthesia Onset Time [Срок оценки: Immediately following local anesthetic injection at each treatment visit.]

Критерии участия

Критерии включения

• Children aged 8-12 years
• Children with no systemic disease
• Children with no pathology involving the oral region, such as trauma, cysts, or tumors
• Children who have not used antibiotics within the past month
• Children who have not used nonsteroidal anti-inflammatory drugs (NSAIDs) within the past month
• Children with at least two homologous permanent molars affected by molar-incisor hypomineralization (MIH) and indicated for restorative treatment due to dentin caries
• Children with a Frankl Behavior Rating Scale score of 3 or higher will be included in the study

Критерии исключения

• Children in whom local anesthesia cannot be administered due to lack of cooperation
• Children who require pulp treatment after enrollment in the study will be withdrawn from the study.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği Fakül — Istanbul

Идентификаторы

NCT: NCT07733011 · tezasli2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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