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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Retention Rate of Fissure Sealants with regard to the type of sealant and AgF pretreatment applied.
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Retention Rate of Fissure Sealants with regard to the type of sealant and AgF pretreatment applied.
时间窗: 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.
The US Public Health Service criteria (secondary caries, anatomical form, marginal adaptation, marginal discoloration) will be used for clinical evaluation of restorations. The restorations will be evaluated at baseline and 1., 6., 12., 18., 24. months. Intra-oral photos will be taken directly after treatment and at control appointments to evaluate discoloration and seconder caries under magnification.
次要结局
- Incidence of Caries(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(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(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(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.)
研究者
Elif Ballikaya
Associated Professor
Hacettepe University