Postoperative Pain After Pulpectomy in Primary Molars

Официальное название

Evaluation of Post Operative Pain Using Single Rotary File System Versus Manual Instrumentation in Pulpectomy of Primary Molars

Обзор

To compare the post operative pain in pulpectomy of primary molars using a single rotary file system versus conventional manual instrumentation, through a Randomized Clinical Trial. The main question it aims to answer is: Is there a difference in post operative pain when using single rotary file system versus manual instrumentation in pulpectomy of primary molars?

Подробное описание

Endodontic procedures remain among the most commonly performed treatments following the diagnosis of pulpal inflammation or pathology. However, in primary teeth, endodontic treatment poses substantial difficulties owing to its complex anatomy and canal systems

* Maintaining a primary tooth after successful root canal treatment is highly beneficial, as the preserved tooth serves as the most effective natural spacemaintainer * In cases of irreversible pulpitis, endodontic therapy remains the most common and frequently performed procedure to alleviate pain * Pulpectomy in primary molars is a critical treatment modality in pediatric dentistry when the pulp is irreversibly inflamed. Traditional instrumentation for pulpectomy often relies on manual files (e.g., stainless steel K-files), which can be time-consuming, technique sensitive, and may pose challenges due to the complex and delicate root anatomy of primary teeth * Rotary nickel-titanium (NiTi) systems have potential advantages: more efficient preparation, reduced chair-time, and possibly better patient cooperation. Indeed, study has found that rotary instrumentation significantly reduces both the instrumentation and obturation time and is associated with lower postoperative pain * Postoperative pain is one way to measure the success of endodontic treatment

Вмешательства

• Устройство Fanta AF F one rotary files 20 taper 4
  Fanta AF F one rotary files 20 taper 4 single rotary file system
• Устройство Manual files (k files ,Mani, Inc., Japan).
  manual files (k files, Mani, Inc., Japan) size 15,20,25,30

Первичные конечные точки

• Post-operative pain [Срок оценки: At 6, 12, 24, 48 and 72 hours and 1 week after Treatment]

Вторичные конечные точки (4)

• child's behavior level [Срок оценки: (Immediately after treatment)]
• Clinical Success [Срок оценки: ( At 3, 6, 12 months)]
• Instrumentation time [Срок оценки: (During procedure start from anathesia till end of procedure)]
• The obturation quality [Срок оценки: (Immediately after treatment)]

Критерии участия

Критерии включения

• • Patients:

• Aged 4-6years, Medically free and Cooperative.
• Teeth:
• Restorable mandibular second primary molars with clinical signs or symptoms of irreversible pulpitis.

Pre-operative Radiographic criteria:

• Absence of internal or external root resorption.
• Absence of periapical or inter-radicular radiolucencies.

Критерии исключения

• • Patients:

• Uncooperative children.
• Children with systemic disease.
• Physical or mental disabilities.
• Refusal of participation.
• Unable to attend follow- up visits.
• Refusal to sign the informed consent.

Teeth:

• Previously accessed teeth.
• Mobile mandibular primary molars.
• Pain on percussion.
• Swelling in the vestibule or on palpation.

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

Египет · 1 центр

• Faculty of Dentistry, Cairo University — Cairo

Идентификаторы

NCT: NCT07427420 · MSc-pedo-pulpectomy-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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