Clinical Evaluation of Permanent Molars With Molar Incisor Hypomineralization Treated With Silver Diamine Fluoride or Silver Modified Atraumatic Restorative Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Clinical performance of SDF+KI and SMART(SDF+KI+GIC) on molars with MIH
研究概览
简要总结
The purpose of this study is to evaluate and compare the clinical performance of Silver diamine Fluoride+Potassium Iodide (SDF+KI) and Silver-Modified Atraumatic Restorative Technique (SMART/SDF+KI+GIC) on molars with MIH
详细描述
SDF+KI and SMART (SDF+KI+GIC) were placed on two permanent molar teeth with MIH, in a split mouth design. 48 patients were included in the study. The teeth were randomized into two groups according to the dental restorative material.
Group 1: SDF+KI (Riva Star), Group 2: SDF+KI (Riva Star) +GIC (Equia Forte). The US Public Health Service criteria (secondary caries, anatomical form, marginal adaptation, marginal discoloration) was used for clinical evaluation of atraumatic resin restorations. The restorations were evaluated at baseline and 1., 6., 12., 18., 24. months. Intra-oral photos were taken directly after treatment and at control appointments to evaluate discoloration and seconder caries under magnification.
Fisher's Exact test, Kaplan-Meier Survival Curves, Log-rank test, Mann Whitney U test, and Friedman test was performed for the statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients and parents of the patients who accept to participate and sign the informed consent
- •Patients whose molar teeth are diagnosed as molar incisor hypomineralization by EAPD
- •Teeth that are fully erupted
- •Patients who have at least two permanent first molars that need fissure sealant
- •Teeth that have white-yellow-brown discoloration that indicate high-caries risk
排除标准
- •Teeth that are previously restored or have caries
- •Patients who have orthodontic treatment
- •Patients who are not cooperative for the dental procedure
- •Teeth that have dental fluorosis or enamel malformation according to the specific syndromes
结局指标
主要结局
Clinical performance of SDF+KI and SMART(SDF+KI+GIC) on molars with MIH
时间窗: 2 years
The US Public Health Service criteria (secondary caries, anatomical form, marginal adaptation, marginal discoloration) will be used for clinical evaluation of atraumatic resin restorations.
次要结局
未报告次要终点
研究者
Zafer Cavit Cehreli, DDS, PhD
Principal Investigator
Hacettepe University