Clinical and Radiographic Performance of Zirconia and Composite Strip Crowns for Primary Incisors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of zirconia and composite strip crowns that showed successful retention over two years
研究概览
简要总结
The purpose of this study is to evaluate and compare the clinical and radiographic performance of zirconia and composite strip crowns bonded on primary incisors
详细描述
Zirconia and composite strip crowns will be placed on at least two primary incisor teeth, in a split mouth design. A caries-free primary incisor tooth will be used as control. 100 patients will be included in the study. The teeth will be randomized into two groups according to the crown type.
Group 1: Zirconia crown 2: Composite Strip Crown 3: Control tooth. Plaque index, gingival index, crown retention, presence of restoration failure, gingival margin extension, color match of the crowns and pulpal health of the teeth will be clinically evaluated at baseline and 1., 6., 12., 18., 24. months. The restorations will be evaluated radiographically at 6., 12. and 18. months. Intra-oral photos will be taken directly after treatment and at control appointments.
The data will be analysed statistically using Fisher's Exact Test and pearson's chi-square test; and Log-rank and the Kaplan-Meier will be used to estimate survival percentages.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients and parent of the patients who accept to participate and sign the informed consent
- •Patients who have at least two primary maxillary incisor with caries that require crown restoration
- •Teeth that have healthy lamina dura and periodontal ligament
- •Teeth with no mobility and enough root length
- •Patients that have good cooperation to the procedure
排除标准
- •Patients and parent of the patients who don't accept to participate and sign the informed consent
- •Teeth that are previously restored
- •Patients who are uncooperative
- •Teeth that doesn't have opposing primary incisors
- •Patients who have bruxism or deep-bite
- •Teeth that are close to be erupted
- •Teeth that have vital or non-vital pulp therapy
研究组 & 干预措施
zirconia crowns
Zirconia crowns placed on primary incisor teeth
干预措施: Zirconia crown (Device)
composite strip crowns
composite strip crowns placed on primary incisor teeth
干预措施: composite strip crown (Device)
Control tooth
Caries-free primary incisor tooth
结局指标
主要结局
Number of zirconia and composite strip crowns that showed successful retention over two years
时间窗: 2 years
Long-term clinical success of zirconia and composite strip crowns placed on primary incisors
次要结局
未报告次要终点
研究者
Zafer Cavit Cehreli, DDS, PhD
Prof.Dr.
Hacettepe University