Custom-made Versus Prefabricated Zirconia Crowns for Primary Molars; a Clinical Trial With 12-month Follow-up.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in periodontal health.
研究概览
简要总结
Background: Do construction methods of pediatric zirconia crowns affect the periodontal health and clinical performance of badly decayed primary molars? The question asked by many practitioners.
Purpose: to compare the periodontal health and clinical performance of primary molars restored with custom-made and prefabricated zirconia crowns. Hypothesis is the performance of primary molars restored with custom-made zirconia crowns will be equivalent to those restored with prefabricated zirconia crowns.
详细描述
This study is a randomized, 12-month follow up clinical trial. According to sample size calculation, ten patients will be selected in conjunction with departments of Pedodontics and Crowns & Bridges. The study will be conducted in accordance with the principles of the Research Ethics Committee, Faculty of Dental Medicine for Girls, Al-Azhar University, Egypt.
The purpose of the investigation and the clinical procedures of this study will be explained to the parents and children. A written informed consent form will be signed from patient guardians and obtained prior to study initiation. The inclusion and exclusion criteria are established as the following;
- Inclusion criteria
- Children of 5-9 years old.
- The children have at least 2 pulpotomized primary molars with no clinical signs & symptoms or periapical pathosis.
- Presence of an intact contralateral primary molar as a control.
- Willingness to participate and to continue with the follow up appointments.
- Clinical and radiographically confirmed dental caries extending to the middle third of dentin.
- Presence of teeth in opposite arch with normal occlusion.
- Exclusion criteria
- Children with systemic health problem.
- Children with periodontal disease.
- Children with unilateral chewing habit or allergic to local anesthesia.
- Presence of parafunctional habit.
- Clinical procedure;
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 5 Years 至 9 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of 5-9 years old.
- •The children have at least 2 decayed primary molars.
- •Presence of an intact contralateral primary molar as a control.
- •Willingness to participate and to continue with the follow up appointments.
- •Clinical and radiographically confirmed dental caries extending to the middle third of dentin.
- •Presence of teeth in opposite arch with normal occlusion.
排除标准
- •Children with systemic health problem.
- •Children with periodontal disease.
- •Children with unilateral chewing habit or allergic to local anesthesia.
- •Presence of parafunctional habit.
结局指标
主要结局
Change in periodontal health.
时间窗: At 1, 3, 6 and 12 months following application.
The periodontal health will be assessed using the plaque index (PI) and the gingival index (GI)
次要结局
- Change in clinical performance.(At 1, 3, 6 and 12 months following application.)
研究者
Roqaia Mohammad Alassar
Lecturer of Crowns and Bridges, Faculty of Dental Medicine for Girls, Al-Azhar University
Al-Azhar University
