Evaluation of Instrumentation Time and Obturation Quality Using Two Different Pediatric Rotary File Systems in Primary Molar Pulpectomy

Официальное название

Evaluation of Instrumentation Time and Obturation Quality Using Two Different Pediatric Rotary File Systems in Primary Molar Pulpectomy :(A Randomized Clinical Trial)

Обзор

Preserving primary teeth is essential for maintaining normal chewing, speech development, and psychological well-being. Successful pulpectomy depends on effective chemomechanical preparation of the root canals while preserving their original anatomy. Although hand files are traditionally used for canal preparation in primary teeth, they are time-consuming and may increase the risk of procedural errors. Nickel-titanium (Ni-Ti) rotary systems have gained popularity because they improve canal shaping and reduce instrumentation time. Among these systems, Pediatric NiTi rotary files manufactured with AF-H Wire technology and Pediatric NiTi rotary files manufactured with blue Wire technology are specifically designed for pediatric use. However, evidence regarding their clinical performance remains limited, highlighting the need to compare their effectiveness, particularly in terms of instrumentation time and obturation quality

Вмешательства

• Устройство Pediatric NiTi rotary files manufactured with AF-H Wire technology
  After preoperative radiographic assessment and administration of local anesthesia, lower primary molars will be isolated using a rubber dam and caries will be removed. Working length will be determined radiographically, and root canal preparation will be performed using pediatric NiTi rotary files manufactured with AF-H Wire technology with 1% sodium hypochlorite irrigation between files. Instrumentation time will be recorded throughout the procedure. The canals will then be dried and obturated
• Устройство Pediatric NiTi rotary files manufactured with blue wire technology
  After preoperative radiographic assessment and administration of local anesthesia, lower primary molars will be isolated using a rubber dam and caries will be removed. Working length will be determined radiographically, and root canal preparation will be performed using blue technology wire rotary files with 1% sodium hypochlorite irrigation between files. Instrumentation time will be recorded throughout the procedure. The canals will then be dried and obturated with Metapex, followed by restora

Первичные конечные точки

• instumentation time [Срок оценки: same visit while performing the pulpectomy]

Вторичные конечные точки (1)

• obturation quality [Срок оценки: same visit after pulpectomy completion]

Критерии участия

Критерии включения

• Healthy Cooperative children.
• Children between the ages of four and eight years.
• Restorable teeth with irreversible pulpitis.
• Continuous bleeding after amputation of coronal pulp tissue.

Критерии исключения

• Molars that exhibit physiologic root resorption in excess of one-third.
• Internal and external root resorption.
• Presence of dental abscess, sinus tract or excessive mobility.
• Acute spreading infection/cellulitis not manageable with local treatment.
• Large periapical/furcation lesion with poor prognosis.
• Teeth close to natural exfoliation.
• Children with known allergies to study materials or medications used.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07672990 · CU-rania-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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