This Study Aims to Evaluate the Effect of Rinsing Off or Blot-drying Silver Fluoride on the Retention of Subsequently-applied Resin- and Glass Ionomer-based Fissure Sealants in Permanent Molars Affected by Molar-Incisor Hypomineralization.

Официальное название

The Effect of Rinsing Off or Blot-drying Silver Fluoride on the Retention of Subsequently-applied Resin- and Glass Ionomer-based Fissure Sealants in Permanent Molars Affected by Molar-Incisor Hypomineralization.

Обзор

The aim of this study is three-fold: 1. To evaluate the clinical performance of glass ionomer fissure sealants and resin fissure sealants when placed immediately after or one week following the application of silver fluoride on permanent molars affected by Molar-Incisor Hypomineralization in high caries-risk children. 2. To compare the effects of rinsing off the silver fluoride or not rinsing it off (blot-drying with cotton pellet) on sealant retention when the sealant is placed immediately after silver fluoride application, and 3. To measure the desensitizing effect of fissure sealant application following silver fluoride treatment on hypersensitive MIH molars.

Подробное описание

Teeth will be randomized in a parallel design based on the application of restoration time (immediate or one week later), sealant material type (resin or glass ionomer), and for immediate applications, the condition of silver fluoride before restoration (dried with cotton or rinsed gently). A total of 216 permanent molars will be included in the study.

Randomization of molar teeth into six groups according to the restoration time, dental restorative material type, and conditions:

Вмешательства

• Устройство Immediate restoration (resin- based) after blot-drying silver fluoride application
  Blot-drying silver fluoride with cotton pellet followed by resin-based fissure sealant
• Устройство Immediate restoration (GI- based) after blot-drying silver fluoride application
  Blot-drying silver fluoride with cotton pellet followed by glass ionomer-based fissure sealant
• Устройство Immediate restoration (Resin based) after rinsing silver fluoride application
  Rinsing silver fluoride off followed by resin-based fissure sealant
• Устройство Immediate restoration (GIC) after rinsing silver fluoride application
  Rinsing silver fluoride off and blot-drying of fissures followed by glass ionomer-based fissure sealant
• Устройство Resin based fissure sealant restoration one week after silver fluoride (AgF) application
  Resin based fissure sealant restoration one week after silver fluoride (AgF) application
• Устройство GI- based fissure sealant restoration one week after silver fluoride (AgF) application
  GI- based fissure sealant restoration one week after silver fluoride (AgF) application

Первичные конечные точки

• Retention Rate of Fissure Sealants with regard to the type of sealant and AgF pretreatment applied. [Срок оценки: From enrollment to the end of treatment: 14 months (from July 2023 to October 2024). The first-year outcomes are planned for October 2025, and the second-year outcomes are planned for October 2026.]

Вторичные конечные точки (4)

• Incidence of Caries [Срок оценки: From enrollment to the end of treatment: 14 months (from July 2023 to October 2024). The first-year outcomes are planned for October 2025, and the second-year outcomes are planned for October 2026.]
• Marginal Integrity of Sealants [Срок оценки: From enrollment to the end of treatment: 14 months (from July 2023 to October 2024). The first-year outcomes are planned for October 2025, and the second-year outcomes are planned for October 2026.]
• Tooth Sensitivity [Срок оценки: From enrollment to the end of treatment: 14 months (from July 2023 to October 2024). The first-year outcomes are planned for October 2025, and the second-year outcomes are planned for October 2026.]
• Color and esthetic Changes [Срок оценки: From enrollment to the end of treatment: 14 months (from July 2023 to October 2024). The first-year outcomes are planned for October 2025, and the second-year outcomes are planned for October 2026.]

Критерии участия

Критерии включения

• Patients and their parents who consent to participate and have signed the informed consent form.
• Patients with at least one permanent molar diagnosed with molar incisor hypomineralization based on EAPD guidelines.
• Fully erupted teeth with ICDAS I or II lesions that necessitate the application of fissure sealants.
• Teeth displaying demarcated opacities on the occlusal surface and at least one additional surface.

Критерии исключения

• Teeth that have existing restorations or cavities.
• Patients currently receiving orthodontic treatment.
• Patients who are uncooperative during dental procedures.
• Teeth affected by dental fluorosis or enamel defects associated with specific syndromes.
• Children with systemic conditions requiring ongoing medication.

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

Открытое

Основная цель

Профилактика

Центры проведения

Turkey (Türkiye) · 1 центр

• Hacettepe University Faculty of Dentistry, Department of Pediatric Dentistry — Ankara

Публикации

• Cayiroglu N, Ballikaya E, Unverdi GE, Cehreli ZC. Effectiveness of fissure sealants following different silver fluoride application protocols in MIH-affected molars: randomized clinical study. Clin Oral Investig. 2026 Mar 31;30(4):164. doi: 10.1007/s00784-026-06856-1. PMID 41915094

Идентификаторы

NCT: NCT06641011 · TDH-2024-21181 · TDH-2024-21181

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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