Comparative Evaluation of Egg Shell based Hydroxyapatite, Feracrylum Gel and Mineral Trioxide Aggregate as Pulpotomy agent in Primary Molars : A Three-Arm Randomised Controlled Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical and Radiographic Success
研究概览
简要总结
The study is a randomised double-blind parallel multi arm trial, comparing and evaluating the use of X based hydroxyapatite, feracrylum gel, and mineral trioxide aggregate as pulpotomy agent in primary molars in 60 children who reported to the outpatient department of Department of paediatric dentistry at Terna dental College. The primary outcome measures the clinical and radiographic success of these three medicaments when used as pulpotomy agents in children between the age group of 4 to 10 years of age. The study operates on the null hypothesis that there is no difference in the clinical and radiographic success rate of these three medicaments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy children between 4-10 years of age with Frankl’s behaviour rating scale of 3 and
- •One or more restorable carious primary molars with deep carious lesions approximating or reaching the pulp after Radiograph examination.
- •3.Pain does not persist after the removal of stimulus.
- •4.Presence of at least two-thirds root length.
- •5.No widening of Periodontal Ligament (PDL) space and no apical or furcal radiolucency.
排除标准
- •Children exhibiting Frankl’s behaviour rating scale of 1 and
- •History of pathological mobility, tenderness on percussion, internal or external resorption, swelling or sinus tract.
- •Hemostasis not achieved within 5 minutes after coronal pulp amputation.
- •History of spontaneous or persistent pain.
- •No Pulpal exposure while excavation of caries.
- •Patient or parent not willing to be part of the study.
结局指标
主要结局
Clinical and Radiographic Success
时间窗: Clinical and Radiographic outcome will be assessed at baseline, 3 months, 6 months, 9 months, 12 months
次要结局
未报告次要终点