Набор скоро начнётся NCT07065305

Clinical Performance and Remineralization Potential of Self- Assembling Peptide P11-4 Containing Fluoride Versus Er, Cr: YSGG Laser Treatment and Micro Tensile Bond Strength of Giomer Restoration in Carious Lesions

Ранняя фаза I С лечением Remineralization Potential Dentin Caries

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: Curodont Repair Fluoride Plus (Self-assembling peptide remineralization agent)P11-4 peptide, fluoride, mild acidic buffer (pH ~4.5) , Credentis AG, Switzerland, Beautifil II LS.
Кому может быть актуально: Состояния в реестре: Remineralization Potential, Dentin Caries. Базовые параметры: 20 лет — 40 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: Список центров уточняется — проверьте первичный протокол.
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This study will be performed in two parts, in vivo and in vitro to assess the effect of the remineralization potential of self-assembling peptide P11-4 containing Fluoride on caries-affected dentin compared to untreated caries-affected dentin and the influence of Er, Cr: YSGG Laser treatment.

Подробное описание

The present study will be performed to evaluate the remineralization potential of the self-assembling peptide P11-4 combined with fluoride treatment applied over demineralized dentin in occlusal carious molars.

* Research objectives: To assess the effect of the two treatment modalities to enhance remineralization of demineralized dentin and clinical performance of restorations. * Research question: Will pretreatment of caries affected dentin using self-assembling peptide P11-4 containing fluoride compared to untreated caries-affected dentin will enhance the remineralization and clinical performance of composite restorations In Vitro Study

1- The present study will be performed to evaluate the remineralization potential of the self-assembling peptide P11-4 combined with fluoride and its effect on bond strength and analyze morphological changes over demineralized dentin in occlusal carious molars using Scanning Electron Microscopy (SEM). * Research Objectives: To evaluate the effect of Curodont Repair Fluoride Plus and Er,Cr:YSGG laser pretreatment on the bond strength of composite resin to superficial and deep dentin. * Research question: Will pretreatment of caries affected dentin using self-assembling peptide P11-4 containing fluoride compared to untreated caries-affected dentin will enhance bond strength?

Вмешательства

Препарат Curodont Repair Fluoride Plus (Self-assembling peptide remineralization agent)P11-4 peptide, fluoride, mild acidic buffer (pH ~4.5) , Credentis AG, Switzerland
Pretreatment with Curodont Repair Fluoride Plus (P11-4 + fluoride)
Препарат Beautifil II LS
Application of Giomer restorative material following standard adhesive procedures without pretreatment.

Первичные конечные точки

Marginal integrity of restorations [Срок оценки: 6 months and 12 months]
Clinical longevity of restorations [Срок оценки: 6 and 12 months]
Overall clinical performance of restorations [Срок оценки: 6 and 12 months]

Вторичные конечные точки (5)

Postoperative hypersensitivity [Срок оценки: 6 and 12 months]
Marginal discoloration [Срок оценки: 6 and 12 months]
Recurrent caries [Срок оценки: 6 and 12 months]
Surface roughness [Срок оценки: 6 and 12 months]
Surface luster [Срок оценки: 6 and 12 months]

Критерии участия

Критерии включения

o Patients aged (20 - 40) years.

Presence of at least one posterior permanent molar with an occlusal carious lesion classified as ICDAS code 3 or 4 requiring operative treatment.
Good general and oral health.
Willingness to participate and provide informed consent.