A Prospective Randomized Clinical Trial of Two Types of Aesthetics Crowns Used in Restoration of Carious Primary Molars
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Clinically susccessful
研究概览
简要总结
Currently, prefabricated zirconia crowns have been used as an aesthetic restorative material for primary teeth for a few years. Another recently introduced esthetic crown is the Bioflx™ crown. It is made of a resin polymer and claimed to have high strength , flexibility and durability. The aim of this study is to evaluate and compare the clinical and radiographic success of zirconia crowns to that of Bioflx™ crowns in carious primary molars.
详细描述
Background: Little is known about aesthetic management of decayed primary posterior teeth in children which often requires full-coverage restorations.
Aim: The aim of this study is to evaluate and compare the clinical and radiographic success of zirconia crowns to that of Bioflx™ crowns in carious primary molars.
Methods: this study design is a split mouth randomized controlled clinical trial including children ages between 4-10 years old. Each patient will receive a zirconia crown and Bioflx™ crown on either side of the maxillary or mandibular arch. Clinical procedure: The patients will be randomly allocated to receive either crown on the first visit, and the other type on the next visit which will be 1-2 weeks after. Children and teeth meeting the inclusion criteria will be included. Crowns will be prepared under local anesthesia and rubber dam isolation. Crowns will be evaluated at 1, 6, 12 and 24-month recall appointments according to pre-set success and failure criteria.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 4-10 years
- •Healthy child
- •Child is cooperative
- •Subject has a minimum of two bilateral carious upper or lower primary molars
- •Teeth exhibiting carious lesions clinically and radiographically
- •Teeth selected should be fully erupted, with no evidence of tooth fracture, and could be isolated adequately for crown cementation
排除标准
- •Tooth close to exfoliation
- •Medical problems in sbjects
- •Children requiring advanced behaviour management
- •Those not available for future recalls/ follow up
研究组 & 干预措施
Zirconia esthetic crowns
Zirconia esthetic crowns
干预措施: Zirconia crown (Procedure)
Bioflx esthetic crowns
Bioflx esthetic crowns
干预措施: Bioflx crown (Procedure)
结局指标
主要结局
Clinically susccessful
时间窗: 24 months
Normal gingiva (no inflammation or edema) Normal occlusion (not high in occlusion) Parent satisfied (as reported) Child satisfied (as reported)
次要结局
未报告次要终点