Effect of Two Different Luting Cements on Clinical Outcomes of Pediatric Zirconia Crowns: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Retention
研究概览
简要总结
The study aims to compare the efficacy of using bioactive cement versus resin-cement for cementation of anterior pediatric zirconia crowns.
详细描述
- For the bioactive cement group (Predicta® Bioactive Cement), the prepared tooth will be dried using compressed air but not desiccated. Cement will be dispensed through the auto-mixtip directly into the crown, and the crown will be properly positioned over the tooth; cement will be allowed to self-set for 20 seconds while maintaining gentle pressure on the crown. Buccal and lingual margins will be flash-cured for 10 seconds each using a light-curing unit to immediately cure the excess cement for easier removal, and buccal and lingual surfaces will then be light-cured for an extra 10 seconds each.
- For the resin-cement group, the tooth will be dried with compressed air but not desiccated. The sealant will be applied with the syringe; then, the crown will be appropriately positioned over the tooth, and cement will be allowed to self-set for 2 minutes and cured while maintaining gentle pressure on the crown. Excess cement will be removed before the cement is completely set.
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 (Participant)
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 who had no history of allergies
- •Children who had at least two carious primary incisors.
- •Teeth with multi-surface carious lesion.
- •Teeth with no percussion or palpation sensitivity
- •Teeth with no abscess and/or fistula
- •Teeth with no prior pulpal treatment
- •Teeth with no mobility or signs of periodontal disease
排除标准
- •Children with congenital developmental defects (such as amelogenesis imperfecta and dentinogenesis imperfecta)
- •Children with a history of bruxism, trauma or infraocclusion
- •Children with a skeletal or dental malocclusion
研究组 & 干预措施
Arm 1
Zirconia crown cemented with Predicta® Bioactive Cement
干预措施: Zirconia crown cemented with Predicta® Bioactive Cement (Drug)
Arm 2
Zirconia crown cemented with resin-cement
干预措施: Zirconia crown cemented with resin-cement (Drug)
结局指标
主要结局
Retention
时间窗: 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months
Retention will be assessed by visual inspection and probe to detect debonded crowns.
Fracture
时间窗: 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months
Fractures will be assessed using visual inspection to detect incomplete fracture lines or complete fractures with loss of crown material.
次要结局
- The gingival condition(1 week, 1 month, 3 months, 6 months, 9 months, and 12 months)
研究者
Rasha Mohamed Hatem Hanafy
Associate Professor of Pediatric Dentistry and Dental Public Health
Cairo University