Resin Infiltrate as Pit and Fissure Sealant in Permanent Molars

Официальное название

Evaluation of Resin Infiltrate as Pit and Fissure Sealant in Permanent Molars (In Vivo& In Vitro)

Обзор

The aim of this study is to evaluate and compare the clinical effectiveness of ICON resin Infiltration versus conventional sealant and the microleakage and penetration depth of the two sealant materials.

Подробное описание

Using the resin infiltration technique as a different approach for sealing pits and fissures creates a diffusion barrier as resin infiltrate tends to inhibit enamel pores that serve as diffusion channels for acids and dissolved minerals within the lesion body. A low-viscosity resin that can penetrate into caries lesions, which is referred to as resin infiltration technique. The mechanisms associated with this method depend on the infiltration of subsurface lesions with low-viscosity light-curing resins after eroding the highly mineralized surface layer and increasing penetration depth. This method is believed to overcome the limitations of sealant applications and is considered to be a better alternative for the treatment of initial caries lesions.

Вмешательства

• Препарат ICON resin infiltration Material group in vivo
  The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK).
• Препарат Resin-based fissure sealant group in vivo
  The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael)
• Препарат ICON resin infiltration in vitro
  The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK) in vitro
• Препарат Resin-based fissure sealant in vitro
  The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael) in vitro

Первичные конечные точки

• Evaluate the clinical effectiveness of ICON resin and the sealant retention using Simonsen's criteria. [Срок оценки: 3 minutes for application of ICON. The children will be recalled at 3, 6, and 9 months]

Вторичные конечные точки (1)

• Evaluate and compare the microleakage and penetration depth of the two sealant materials [Срок оценки: thirty seconds for application of Heliosael.The children will be recalled at 3, 6, and 9 months]

Критерии участия

Критерии включения

• Age of the children from 6 to 8 years.
• Healthy children free from any systemic disease.
• Show bilaterally sound fully erupted lower first permanent molars with deep narrow central fissures and supplemental grooves.
• The eruption time of these molars should not exceed 3 years.
• No sign of pain or active periodontal disease in the selected teeth.

Критерии исключения

• Children with fillings or sealants in the selected teeth.
• Children with clinical evidence of caries in the selected teeth either white spot lesions or cavities.
• Children with an allergy to any drug, such as resin restorative material.
• Children with Extremely poor oral hygiene.
• Hypoplastic teeth.
• Children with bruxism.

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

Тройное слепое

Основная цель

Профилактика

Центры проведения

Египет · 1 центр

• Salsabeel M Abdelgaffar — Tanta

Публикации

• Lam PPY, Sardana D, Ekambaram M, Lee GHM, Yiu CKY. Effectiveness of Pit and Fissure Sealants for Preventing and Arresting Occlusal Caries in Primary Molars: A Systematic Review and Meta-Analysis. J Evid Based Dent Pract. 2020 Jun;20(2):101404. doi: 10.1016/j.jebdp.2020.101404. Epub 2020 Jan 29. PMID 32473795

Идентификаторы

NCT: NCT06729788 · Resin Infiltrate

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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