Clinical Performance of Alkasite-based Restorations in Children

Официальное название

Clinical Performance of Alkasite-Based Resin Versus Nanohybrid Composite Resin Restorations for Occlusal Carious Lesions in Primary Molars: A Randomized Clinical Trial

Обзор

The aim of this study is to evaluate and compare the clinical performance of alkasite-based resin and nanohybrid composite resin materials in the restoration of occlusal carious lesions in primary molars of children.

Подробное описание

This randomized clinical trial aims to evaluate and compare the clinical performance of an alkasite-based resin restorative material (Cention N®) and a nanohybrid composite resin (TPH Spectra ST Universal Composite) in restoring occlusal carious lesions (Class I) in primary molars among children aged 4-6 years. Participants will be randomly allocated in a 1:1 ratio into two parallel groups and followed for a period of 12 months. The primary outcome will be the incidence of secondary caries assessed at 3, 6, and 12 months using the United States Public Health Service (USPHS) criteria, which grades restorations from Alpha (ideal/excellent) to Delta (failure). Secondary outcomes will include the evaluation of restoration fracture, marginal adaptation, marginal discoloration, surface roughness, and retention, all assessed at the same intervals using the same USPHS criteria.

Вмешательства

• Другое Alkasite-based composite restorations
  Alkasite-based restorations will be used in the treatment of class I carious lesion in primary molars.
• Другое Nano-hybrid resin composite
  Nanohybrid composite will be used in the restoration of Class I carious lesions in primary molars.

Первичные конечные точки

• Incidence of secondary caries [Срок оценки: 12 months]

Вторичные конечные точки (1)

• clinical evaluation of restoration fracture [Срок оценки: 12 months]

Критерии участия

Критерии включения

• • Children aged 4-6 years of both sexes.

• Cooperative children.
• Apparently medically fit children according to parental history.
• Children whose parents agree to sign the informed consent.
• Children whose parents will be able to attend the follow-up.

Teeth:

• Primary molars with occlusal carious lesions (Class I), indicated for direct restorations.
• Teeth without signs of pulpal involvement, abscess, or fractures.

Критерии исключения

Children:

• Children with systemic or mental disorders.
• Children whose parents refused to sign the informed consent.
• Noncompliant parent.
• Uncooperative children.

Teeth:

• Teeth with deep caries involving the pulp or clinical signs of pulpal infection (e.g., swelling, sinus, fistula, pathological mobility).
• Teeth with periapical pathology, internal or external root resorption, or mobility.
• Non-restorable teeth or lacking sufficient structure for restoration

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Cairo University — Cairo

Публикации

• Attia, R., Sabry, R., Elafefy, A., & Essa, M. (2022). Clinical Performance of Alkasite Dental Material and High Viscosity Glass Ionomer Restorations in Class I Cavities. Comparative Study for One Year Follow Up. Egyptian Dental Journal, 68(4), 3881-3894.
• Arora D, Jain M, Suma Sogi HP, Shahi P, Gupta I, Sandhu M. In vivo evaluation of clinical performance of Cention N and glass ionomer cement in proximal restorations of primary molars. J Indian Soc Pedod Prev Dent. 2022 Jan-Mar;40(1):23-29. doi: 10.4103/jisppd.jisppd_108_21. PMID 35439879

Идентификаторы

NCT: NCT07263555 · Alkasite filling and caries

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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