Comparative evaluation of preformed Stainless steel, Bioflx and Zirconia crowns in restoring primary molars – A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- 1. Satisfactory clinical and radiographic performance of preformed Stainless steel crowns in primary molars.
研究概览
简要总结
This study is a randomized, single-blinded, single-centre trial comparing the clinical and radiographic performance of 3 types of preformed crowns- Stainless Steel, Bioflx and Zirconia in restoring primary molars in children in the age group of 4-8 years in the Department of Pediatric and Preventive Dentistry, MAIDS. The primary outcome will depict the clinical and radiographic performance of 3 types of crowns and the secondary outcome will compare the 3 types of crowns. All patients will be evaluated at baseline, 1, 3, and 6 months. The need for this study arises from the lack of comprehensive data on their respective clinical performances in vivo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with atleast one primary molar having signs of irreversible pulpitis indicated for pulpectomy.
- •Children with atleast one primary molar having either abscess, sinus tract or periapical pathology indicated for pulpectomy.
- •Children with primary molar having atleast 2/3rd of its root length.
排除标准
- •Children with any Special Health Care needs or systemic disease.
- •Children with primary molar having developmental anomalies such as amelogenesis imperfecta, dentinogenesis imperfecta, etc.
- •Children with primary molars having less than 2/3rd of its root length.
- •Children with non-restorable primary molars.
- •Children with parafunctional oral habits.
结局指标
主要结局
1. Satisfactory clinical and radiographic performance of preformed Stainless steel crowns in primary molars.
时间窗: baseline (T0), 1 month (T1), 3 months (T2) and 6 months (T3)
2. Satisfactory clinical and radiographic performance of preformed Bioflx crowns in primary molars.
时间窗: baseline (T0), 1 month (T1), 3 months (T2) and 6 months (T3)
3. Satisfactory clinical and radiographic performance of preformed Zirconia crowns in primary molars.
时间窗: baseline (T0), 1 month (T1), 3 months (T2) and 6 months (T3)
次要结局
- 1. Preformed Bioflx crowns show comparable clinical and radiographic performance as Stainless steel and Zirconia crowns in primary molars.(baseline (T0), 1 month (T1), 3 months (T2) and 6 months (T3))
研究者
Dr. Akansha Gupta
Maulana Azad Institute of Dental Sciences