Comparison of the Treatment Outcomes of the Conventional Stainless Steel Crown Restorations and the Hall Technique in the Treatment of Carious Primary Molars
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Failure of stainless steel crowns
研究概览
简要总结
Stainless steel crowns have shown high success in restoring carious primary molars over a longer period of time than conventional restorations. This study aims to evaluate the treatment effectiveness of conventional SSCs restoration and Hall technique in treating carious primary molars
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, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Agree and voluntarily participate in the research (with the patient's parent/guardian consent for participation)
- •Children have a primary molar with at least 2 carious lesions corresponding to International Caries Detection and Assessment System (ICDAS) scores 4 or at least 1 carious lesion corresponding to ICDAS scores 5 and 6.
排除标准
- •Children with systemic diseases such as immunodeficiency, cardiovascular disease, or bleeding disorders.
- •Children are allergic to nickel and resin.
- •Children unable to return for recall visits.
- •Primary molar has signs of pulpal/periapical diseases (irreversible pulpitis, pulp necrosis, loosening, fistula, or abscess).
- •Children are undergoing orthodontic treatment with fixed or removable appliances.
研究组 & 干预措施
Conventional Technique
A stainless steel crown will place on a carious primary molar after preparation
干预措施: Placement of stainless steel crowns on primary molars (Procedure)
Hall technique
A stainless steel crown will place on a carious primary molar without local anesthesia caries removal or any preparation
干预措施: Placement of stainless steel crowns on primary molars (Procedure)
结局指标
主要结局
Failure of stainless steel crowns
时间窗: 12 months
Level 1 failures was considered when there were any signs of failure related to SSCs. Level 2 failures was considered when there were any signs of related pulpal and periapical pathology. Success was considered when Level 1 and 2 failures were absent.
Failure of stainless steel crowns
时间窗: 3 months
Level 1 failures was considered when there were any signs of failure related to SSCs. Level 2 failures was considered when there were any signs of related pulpal and periapical pathology. Success was considered when Level 1 and 2 failures were absent.
Failure of stainless steel crowns
时间窗: 6 months
Level 1 failures was considered when there were any signs of failure related to SSCs. Level 2 failures was considered when there were any signs of related pulpal and periapical pathology. Success was considered when Level 1 and 2 failures were absent.
Failure of stainless steel crowns
时间窗: 9 months
Level 1 failures was considered when there were any signs of failure related to SSCs. Level 2 failures was considered when there were any signs of related pulpal and periapical pathology. Success was considered when Level 1 and 2 failures were absent.
次要结局
- Occlusal contact(12 months)
- Periodontal health(12 months)
- Occlusal contact(0 months)
- Occlusal contact(3 months)
- Occlusal contact(6 months)
- Occlusal contact(9 months)
- Periodontal health(0 months)
- Periodontal health(3 months)
- Periodontal health(6 months)
- Periodontal health(9 months)
研究者
Le Van Nhat Thang
Lecturer
Hue University of Medicine and Pharmacy