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Набор скоро начнётся NCT07437794

Clinical and Radiographic Assessment of Neo Putty MTA Versus Formocresol Used in Vital Pulpotomy of Mandibular Primary Molars

Без фазы С лечением Deep Caries in Primary Molars

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: NeoPutty MTA, Formocresol.
Кому может быть актуально
Состояния в реестре: Deep Caries in Primary Molars. Базовые параметры: 4 лет — 9 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

Clinical and Radiographic Assessment of Neo Putty MTA Versus Formocresol Used in Vital Pulpotomy of Mandibular Primary Molars: A Randomized Clinical Trial

Обзор

This randomized clinical trial aims to evaluate the clinical and radiographic success of NeoPutty MTA compared to formocresol in vital pulpotomy of mandibular primary molars in children aged 4 to 9 years. Participants will be randomly allocated into two groups (1:1) to receive pulpotomy using either NeoPutty MTA or formocresol, followed by restoration with stainless steel crowns. Clinical and radiographic outcomes will be assessed during follow-up visits.

Подробное описание

Pulpotomy is a commonly performed vital pulp therapy in pediatric dentistry. Formocresol has been widely used due to its high clinical success; however, concerns exist regarding its potential toxicity. NeoPutty MTA is a premixed bioceramic material introduced as an alternative pulpotomy agent with improved handling properties and bioactivity. This randomized parallel-group clinical trial will compare NeoPutty MTA versus formocresol in vital pulpotomy of mandibular primary molars. Children aged 4-9 years presenting with asymptomatic carious mandibular primary molars will be recruited from the Pediatric Dentistry Department, Faculty of Dentistry, MSA University. Eligible teeth will undergo standardized pulpotomy procedures, restoration with glass ionomer cement, and stainless steel crowns. Clinical and radiographic follow-up will be performed at scheduled intervals to evaluate success and failure outcomes.

Вмешательства

  • Препарат NeoPutty MTA
    NeoPutty MTA (NuSmile) will be placed directly over the radicular pulp stumps after hemostasis, then the tooth will be sealed with resin-modified glass ionomer cement and restored with stainless steel crown.
  • Препарат Formocresol
    A sterile cotton pellet lightly moistened with a 1:5 dilution of Buckley's formocresol will be placed against the pulp stumps for 3-5 minutes, then removed. Reinforced zinc oxide eugenol will be placed, followed by glass ionomer cement and stainless steel crown restoration.

Первичные конечные точки

  • Postoperative pain [Срок оценки: 1 week postoperatively, 3 months, 6 months, 9 months and 12 months]
Вторичные конечные точки (6)
  • Pain on percussion [Срок оценки: 3 months, 6 months, 9 months and 12 months]
  • Presence of sinus tract, fistula or abscess [Срок оценки: 3 months, 6 months, 9 months and 12 months]
  • Tooth mobility [Срок оценки: 3 months, 6 months, 9 months and 12 months]
  • Widening of Periodontal Ligament Space [Срок оценки: 6 months and 12 months after treatment]
  • Internal and External Root Resorption [Срок оценки: 6 months and 12 months after treatment]
  • Furcal or Periapical Radiolucency [Срок оценки: 6 months and 12 months after treatment]

Критерии участия

Критерии включения

Children with asymptomatic decayed primary mandibular molar(s).

  • Patient and parent showing cooperation and compliance.
  • Children 4-9 years old.
  • Vital carious primary(s) with complete root formation.
  • Asymptomatic teeth or without clinical symptoms of spontaneous pain.
  • No clinical evidence of pulp degeneration like the history of spontaneous or nocturnal pain, tenderness to percussion, pathologic tooth mobility, swelling, or fistulous tract.
  • Both genders will be included.
  • No radiographic evidence of pulp degeneration such as internal root resorption, external root resorption, or furcal radiolucency.
  • Presence of two thirds of the root.
  • Teeth that can be restored.
  • Children with prior parental consent.

Критерии исключения

  • History of any systemic disease.
  • Hemostasis is not achieved within 5 minutes of pulp amputation, by direct contact with a wet cotton pellet before the material placement.
  • The remaining radicular tissue was non-vital (with suppuration or purulence necrosis).

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
Открытое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • October university for modern sciences and arts — Giza

Идентификаторы

NCT: NCT07437794 · Ahmed MSA University

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗