Clinical Evaluation of High Viscosity Glass Ionomer Strip Crowns in Primary Maxillary Incisors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change from baseline to 12 months regarding "Surface roughness"
研究概览
简要总结
The aim of this study was to evaluate the clinical success of modified celluloid strip crown restorations applied using interim therapeutic restoration and high-viscosity glass ionomer cement to the maxillary anterior teeth of children with early childhood caries and cooperation problems.
详细描述
Following the decision on the appropriate size of celluloid strip crown, the tooth will be isolated using roll cottons and the "cavity conditioner" (GC, Japan) will be applied to all surfaces for 10 seconds, washed away and dried with cotton pellets. The selected celluloid strip crown will be filled with a fluoride-releasing bulk fill hybrid glass ionomer cement (EQUIA Forte, GC, Japan) prepared by mixing for 10 seconds in an automatic mixer and placed on the tooth with light pressure. The excess material on the crown margins will be removed with a hand instrument, and the celluloid strip crown will be removed from the tooth. If necessary, the restoration will be polished using a polishing discs. After the crown surface is washed and dried, a nano-filled surface sealant (EQUIA Forte Coat, GC, Tokyo, Japan) will be applied for 10 seconds with a micro-tipped applicator and light cured for 20 seconds. Clinical evaluations will be done at the 3rd, 6th and 12th months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Read the informed consent form and agree to participate in the study
- •Healthy children, aged 2-6 years
- •Presenting at least one primary anterior tooth with a class I, II, IV or V caries lesion
排除标准
- •Uncooperative children
- •The need for vital or non-vital endodontic treatment in the primary tooth to be treated
- •Previously restorated tooth
- •Presence of bruxism, Class III occlusion or deep bite
结局指标
主要结局
Change from baseline to 12 months regarding "Surface roughness"
时间窗: baseline, 3-month, 6-month,12-month
alpha: the surface of the restoration does not have any surface defects bravo: the surface of the restoration has minimal surface defects charlie: the surface of the restoration has severe surface defects
Change from baseline to 12 months regarding "Anatomic form"
时间窗: baseline, 3-month, 6-month,12-month
alpha: The general contour of the restorations follows the contour bravo: the general contour of the restoration does not follow the contour of the tooth charlie: The restoration has an overhang does
Change from baseline to 12 months regarding "Retention"
时间窗: baseline, 3-month, 6-month,12-month
alpha: intact bravo: chipped/loss of material charlie: complete loss of crown
Change from baseline to 12 months regarding "Marginal adaptation"
时间窗: baseline, 3-month, 6-month,12-month
alpha: Explorer does not catch or has one-way catch when drawn across the restoration/tooth interface bravo: explorer falls into crevice drawn across the restoration/tooth interface charlie: Dentin or base is exposed along the margin bravo: The general contour of the restoration does not follow the contour of the tooth charlie: The restoration has an overhang does
Change from baseline to 12 months regarding "Incisal wear"
时间窗: baseline, 3-month, 6-month,12-month
alpha: intact bravo: wear of occlusal surface without tooth surface exposure charlie: wear of occlusal surface with tooth surface exposure
Change from baseline to 12 months regarding "Marginal staining"
时间窗: baseline, 3-month, 6-month,12-month
alpha: there is no discoloration between the restorations and tooth bravo: there is discoloration on less than half of the circumferential margin charlie: there is discoloration on more than half of the circumferential margin
次要结局
未报告次要终点
研究者
Beste Ozgur
assistant professor
Hacettepe University