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Набор скоро начнётся NCT06971055

Moringa Oleifera vs Sodium Hypochlorite for Root Canal Irrigation in Nonvital Primary Molars

Без фазы С лечением Dental Caries Pulp Necrosis Primary Tooth Pulpectomy Pediatric Dentistry

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: Sodium hypochlorite, Moringa Oleifera Leaf Extract.
Кому может быть актуально
Состояния в реестре: Dental Caries, Pulp Necrosis, Primary Tooth Pulpectomy, Pediatric Dentistry. Базовые параметры: 4 лет — 7 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Evaluation of Antimicrobial Efficacy of Moringa Oleifera Leaf Extract Versus Sodium Hypochlorite as Root Canal Irrigants in Pulpectomy of Nonvital Primary Molars: A Randomized Clinical Trial

Обзор

This randomized clinical trial aims to evaluate and compare the antimicrobial efficacy of Moringa Oleifera leaf extract versus sodium hypochlorite as root canal irrigants in pulpectomy of nonvital primary molars in pediatric patients. The study will assess bacterial reduction using blood agar

Подробное описание

This randomized clinical trial is designed to compare the antimicrobial efficacy of Moringa Oleifera leaf extract and sodium hypochlorite when used as root canal irrigants in the pulpectomy of nonvital primary molars in children aged 4 to 7 years. Root canal disinfection in pediatric endodontics is essential due to the complex anatomy of primary teeth and the potential systemic implications of untreated infections.

Sodium hypochlorite (NaOCl) is widely used due to its strong antimicrobial and tissue-dissolving properties but is associated with cytotoxic effects and safety concerns in children. Moringa Oleifera, a plant rich in bioactive compounds such as flavonoids and isothiocyanates, has demonstrated antimicrobial, anti-inflammatory, and antioxidant properties, offering a potentially safer and natural alternative.

A total of 38 participants will be randomly assigned to two equal groups. Group 1 will receive root canal irrigation with 2.5% NaOCl, while Group 2 will be irrigated using an ethanol extract of Moringa Oleifera leaves. The primary outcome will be the diameter of the inhibition zone against Coagulase-Negative Staphylococci measured using a blood agar. The secondary outcome will be the diameter of the inhibition zone against Enterococcus Faecalis measured using a blood agar

The study will be conducted at the outpatient clinics of the Pediatric Dentistry and Dental Public Health Department at the Faculty of Dentistry, Cairo University. All procedures will be performed by a single operator (the principal investigator) using a standardized protocol. Data collection will be blinded at the laboratory and statistical analysis levels to minimize bias.

The results of this study aim to determine whether Moringa Oleifera extract can be a safe, effective, and biocompatible alternative to sodium hypochlorite in pediatric root canal irrigation, ultimately enhancing clinical outcomes and patient experience

Вмешательства

  • Препарат Sodium hypochlorite
    sodium hypochlorite solution will be used as a root canal irrigant during pulpectomy in primary molars. A volume of 3 mL will be delivered into each canal using a syringe with a side-vented needle. Irrigation will be followed by microbial sampling for blood agar
  • Биопрепарат Moringa Oleifera Leaf Extract
    extract of Moringa oleifera leaves will be used as an intracanal irrigant during pulpectomy. A volume of 3 mL will be used per canal, and post-irrigation microbial samples will be analyzed using the same methods as the control group.

Первичные конечные точки

  • Zone of inhibition against Coagulase-Negative Staphylococci [Срок оценки: "Day 1 (Pre- and post-irrigation samples collected during the same visit)"]

Критерии участия

Критерии включения

  • Children aged 4 to 7 years
  • Clinically and radiographically diagnosed with nonvital primary molars requiring pulpectomy
  • Cooperative children who can undergo dental treatment
  • Healthy-appearing children with no systemic, physical, or mental disorders

Критерии исключения

  • Medically compromised or uncooperative children
  • Primary molars indicated for extraction due to:
  • Advanced root resorption (more than two-thirds)
  • Teeth near exfoliation
  • Deep subgingival caries preventing proper restoration
  • Excessive mobility (Miller's Grade 2 or higher)

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
Простое слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo Unive — Cairo

Идентификаторы

NCT: NCT06971055 · Moringa vs Sodium Hypochlorite

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗