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Набор по приглашению NCT06777381

Comparison of Post-Operative Pain Occurrence After Single Visit Root Canal Treatment

Без фазы С лечением Symptomatic Irreversible Pulpitis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: single visit root canal treatment using ProTaper Universal rotary system, single visit root canal treatment using M-Pro rotary system.
Кому может быть актуально
Состояния в реестре: Symptomatic Irreversible Pulpitis. Базовые параметры: 25 лет — 45 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
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Официальное название

Comparison of Post-Operative Pain Occurrence After Single Visit Root Canal Treatment with Two NiTi Rotary Files - a Randomized Clinical Trial

Обзор

The goal of this clinical trial is to compare the post-operative pain occurrence after single visit root canal treatment using Two NiTi Rotary Files. The main question it aims to answer is: • Does an instrument design and instrumentation technique could affect postoperative pain incidence and intensity? Researchers will use ProTaper Universal rotary system or M-Pro rotary system for root canal preparation and compared postoperative pain intensity. Participants will receive single visit endodontic treatment using either ProTaper or MPro systems for root canal preparation. Participants will record Pain intensity at 24 hours and 7 days post-operative. Analgesics will be prescribed for the patients in need.

Подробное описание

The main cause of patient fear is expecting pain during root canal treatment. It is considered a major concern for dentists as well. During root canal preparation, periapical extrusion of pulpal tissue remnants, microorganisms or dentin chips may be one of the causes of postoperative pain. Depending on the fact that, instrument design and instrumentation techniques have an impact on the amount of extruded debris apically, many studies proved the ability of some rotary systems to reduce debris extrusion, permitting to achieve less pain sensation.

Therefore, the present clinical study aims to compare the postoperative pain intensity in molars with symptomatic irreversible pulpitis after single endodontic treatment visit using a full-sequence rotary Ni-Ti system either ProTaper or MPro systems Eighty patients with symptomatic irreversible pulpitis in mandibular first molars will be assigned into two groups. In group A (n=40): root canal preparation will be performed in single visit using ProTaper Universal system and in group B (n=40): root canal preparation will be performed in single visit using M-Pro rotary system. Pain intensity will be recorded by the patient using Numerical Rating Scale (NRS) at 24 hours and 7 days postoperative. Analgesics will be prescribed for the patients in case of need.

Вмешательства

  • Процедура single visit root canal treatment using ProTaper Universal rotary system
    single visit endodontic treatment will be performed using ProTaper Universal rotary system for root canal preparation.
  • Процедура single visit root canal treatment using M-Pro rotary system
    single visit endodontic treatment will be performed using MPro rotary systems for root canal preparation.

Первичные конечные точки

  • Record the intensity of postoperative pain after root canal treatment with ProTaper Universal and M-Pro endodontic rotary files. [Срок оценки: 7 days]

Критерии участия

Критерии включения

  • Patient's diagnosis is symptomatic irreversible pulpitis in mandibular first molar.
  • Males and females patients in a good health.
  • Aged from 25 to 45 years old.
  • Pulp vitality is confirmed with cold pulp test and an electric pulp test.

Критерии исключения

  • Pregnant females.
  • Patients complaining from pain in more than one molar on the same side.
  • Patients whose teeth react positively to percussion test.
  • Patients who receive analgesics 12 hours before the start of the root canal treatment.
  • Teeth having grade 2 or 3 mobility.
  • Presence of periapical radiolucency or teeth with extra oral or intraoral sinus tract or fistula.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Dental Clinic at Medical Research Centre of Excellence, National Research Centre — Cairo

Публикации

  • Khallaf ME, Aly Y, Mohamed AI. Comparison of post-operative pain prevalence after single visit endodontic treatment with two NiTi rotary files - a randomized clinical trial. Sci Rep. 2025 Dec 18;15(1):44128. doi: 10.1038/s41598-025-29029-8. PMID 41413418

Идентификаторы

NCT: NCT06777381 · 03460224

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗