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Набор по приглашению NCT07504614

Pre-etched Bioactive Versus Resin- Based Fissure Sealant for Permanent Molars Affected With Molar Incisor Hypomineralization (MIH): a Randomized Clinical Trial

Без фазы С лечением Molar Incisor Hypomineralization Fissure Sealant

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: Pre-etched Bioactive Sealant, Conventional Resin-based Sealant.
Кому может быть актуально
Состояния в реестре: Molar Incisor Hypomineralization, Fissure Sealant. Базовые параметры: 6 лет — 12 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
Иордания
Следующий шаг
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Официальное название

Pre-etched Bioactive Versus Resin- Based Fissure Sealant for Permanent Molars Affected With Molar Incisor Hypomineralization (MIH): A Randomized Clinical Trial

Обзор

This study aims to evaluate and compare the clinical performance of pre-etched bioactive fissure sealants to conventional RBFS in permanent molars affected by MIH in terms of retention, marginal integrity, caries prevention effect, and sensitivity.

Подробное описание

Molar Incisor Hypomineralization (MIH) poses a significant clinical challenge in pediatric dentistry due to enamel fragility, hypersensitivity, and increased susceptibility to caries. While conventional resin-based fissure sealant (RBFS) is the gold standard fissure sealant material for occlusal caries, its performance on hypomineralized enamel remains suboptimal. Bioactive sealants are newly developed materials that promote remineralization and utilize both mechanical and chemical adhesion; however, they demonstrate poor retention when used with their self-etching primer. Bioactive sealants with phosphoric acid pre-etching may offer improved clinical outcomes for MIH-affected teeth. This study aims to evaluate and compare the clinical performance of pre-etched bioactive fissure sealants to conventional RBFS in permanent molars affected by MIH in terms of retention, marginal integrity, caries prevention effect, and sensitivity. Participants will be randomly allocated to receive either a bioactive sealant with phosphoric acid pre-etching or conventional RBFS. Clinical evaluations will be performed at 3-, 6-, and 12- months post-application using Modified United States Public Health Service (USPHS) criteria to assess retention, marginal adaptation, and secondary caries formation. Pre and postoperative sensitivity will be measured using the Schiff Cold Air Sensitivity Scale (SCASS).

Вмешательства

  • Процедура Pre-etched Bioactive Sealant
    Application of the bioactive sealant after etching, washing, drying, and primer use.
  • Процедура Conventional Resin-based Sealant
    Application of resin-based fissure sealant after etching, washing, drying and bonding.

Первичные конечные точки

  • Sealant retention [Срок оценки: 3,6 and 12 months]
  • Marginal integrity [Срок оценки: 3,6 and 12 months]
  • Marginal discoloration [Срок оценки: 3,6 and 12 months]
  • Secondary Caries [Срок оценки: 3,6 and 12 months]
  • Anatomic form [Срок оценки: 3,6 and 12 months]
  • Surface Texture [Срок оценки: 3,6 and 12 months]
Вторичные конечные точки (1)
  • Sensitivity [Срок оценки: Pre-operative, 3,6, and 12 months]

Критерии участия

Критерии включения

  • 6-12-year-old patients with at least one fully erupted first permanent molar (FPM) diagnosed with MIH defects (White, creamy, or yellow to brownish opacities greater than one millimetre) without posteruptive enamel breakdown or caries (ICDAS code 0 or 1).
  • Non -contributory medical history
  • Children must exhibit sufficient cooperation for treatment.
  • FPMs status of eruption must allow for proper isolation. Exclusion Criteria:-
  • Medically compromised patient.- Partially erupted MIH first permanent molars that could not be sufficiently isolated.
  • Carious molars.
  • Restored MIH molars.
  • Sealed MIH molars.
  • MIH molars with extensive enamel breakdown that requires restoration.
  • MIH molars planned for extraction (compensatory or balancing extraction) as part of elective extraction plan of MIH molars with poor long-term prognosis.
  • Molars affected with other enamel defects ((e.g., amelogenesis imperfecta or fluorosis)
  • Non-MIH affected molars.
  • Parents did not consent for treatment.
  • Child not sufficiently cooperative for treatment.

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
Профилактика

Центры проведения

Иордания · 1 центр
  • Jordan University of Science and Technology — Irbid

Идентификаторы

NCT: NCT07504614 · 196-2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗