Comparative evaluation of Platelet Rich Plasma, Platelet Rich Fibrin and Mineral Trioxide Aggregate as pulpotomy agents in primary molars
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate Clinical comparison of Platelet Rich Plasma, Platelet Rich Fibrin and mineral trioxide aggregate as a pulpotomy agents in primary molars
研究概览
简要总结
Patients will be recruited from the outpatient settings of Department of Dentistry (Unit of Pedodontics and Preventive Dentistry), University College of Medical Sciences and Guru Teg Bahadur Hospital. All healthy children having carious primary molars in mandibular arch, satisfying inclusion and exclusion criteria will be included in the study. In the study there will be total of 60 carious teeth, which will be allocated to three groups using simple randomization method.
The study will consist of three groups:
Group 1: Platelet Rich Plasma
Group 2: Platelet Rich fibrin
Group 3: Mineral Trioxide Aggregate
A sample of 60 carious teeth will be treated with standardized pulpotomy procedure, dividing it into three groups of 20 carious teeth in each group. Clinical evaluation for pain, swelling, and tenderness to percussion will be done at 24 hours, and after every 1, 3, 6 and 9 months. The radiographic evaluation included: periodontal space widening, internal resorption, periapical radiolucency and furcation radiolucency will be assessed in 3, 6 and 9 months respectively.
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
- •Healthy children in age group of 4-8years.
- •Patient compliance with treatment.
- •No spontaneous or nocturnal pain and tenderness to percussion.
- •Caries removal results in pulp exposure with normal pulp or reversible pulpitis.
- •Ease of hemorrhage control post access-opening and excavation from amputated pulp stumps.
排除标准
- •Existence of spontaneous pain or nocturnal pain, with clinical signs or symptoms of pulp degeneration (swelling, abscess, fistula, pathologic mobility).
- •Caries penetrating the floor of pulp chamber.
- •Radiographic evidence of teeth with internal resorption.
- •Teeth with physiologic resorption of root not more than one third with restorable remaining tissue.
- •Presence of inter-radicular bone loss.
- •Tooth close to natural exfoliation.
- •Teeth with developmental defects.
- •Children with special health care needs.
结局指标
主要结局
To evaluate Clinical comparison of Platelet Rich Plasma, Platelet Rich Fibrin and mineral trioxide aggregate as a pulpotomy agents in primary molars
时间窗: Over a period of 3,6 and 9 months
次要结局
- To evaluate Radiographic comparison of Platelet Rich Plasma, Platelet Rich Fibrin and mineral trioxide aggregate as a pulpotomy agents in primary molars(Over a period of 3,6 and 9 months)
研究者
Dr Aman Kumar
UCMS & GTBH Dilshad Garden Delhi 110095