Effectiveness Of Zirconia Reinforced Glass Ionomer Used In Alternative Restorative Treatment In Molar Incisor Hypomineralization (A Randomized Controlled Clinical Trial And Finite Element Analysis)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Change in clinical success rate
研究概览
简要总结
Molar-incisor hypomineralization (MIH) is a qualitative enamel defect, in which molars and incisors involved are prone to post-eruptive enamel breakdown leading to sensitivity, and caries. Atraumatic/Alternative Restorative Treatment (ART) is a minimally invasive procedure. It can be very beneficial in managing MIH-affected molars in communities with limited access to dental care. Zirconia-reinforced GI was recently introduced. It is claimed to serve as a long-term temporary restoration until a more permanent restoration is placed
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children free from any systemic disease (ASA I).
- •Cooperative children showing positive or definitely positive behavior according to Frankl rating scale
- •Hypomineralized first permanent molars that are restorable according to MIH Treatment Need Index (MIH-TNI): Index (2a), (2b), (4a), (4b)
- •Teeth with dentinal lesions corresponding to ICDAS II score 5 or 6
- •No clinical or radiographic evidence of pulpal involvement.
排除标准
- •Index (0), (1), (2c), (3), (4c) on the MIH Treatment Need Index.
- •Patients whose parents will not give their consent to participate in the study
- •Non-restorable first permanent molars indicated for extraction
研究组 & 干预措施
Test group
干预措施: zirconomer (Other)
Control
干预措施: HVGI-Equia Forte (Other)
结局指标
主要结局
Change in clinical success rate
时间窗: at 3 months, 6 months, 9 months, 12 months
It will be assessed using Modified ART criteria, restorations receiving a score of: (0) Restoration is present and satisfactory OR (1) Restoration is present, slight defect at the cavity margin of less than 0.5 mm; no repair is needed. will be considered successful, and any other score will be considered a failure.
次要结局
- Change in pain(at 1 week, 3 months, 6 months, 9 months, 12 months)
- Change in sensitivity(at 1 week, 3 months, 6 months, 9 months, 12 months)
- Finite element analysis(12 months)
研究者
Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Alexandria University