The Clinical and Radiographic Efficacy of Biodentine™ and White Mineral Trioxide Aggregate in Deciduous Molar Pulpotomy - a Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Radiographic successes after pulpotomy.
研究概览
简要总结
A clinical trial to evaluate and compare three different products used for endodontic treatment (taking the infected nerve out of the teeth) of primary teeth.
Null Hypothesis: The new biological products (WMTA and Biodentine) behave as good as the former iodoform product.
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
- 2 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients (Children with carious deciduous molars indicated for pulpotomy) belonging to the category of ASA I according to the 'American Society of Anaesthesiologists'.
- •Patients without any known medical history of systemic complications contradicting pulp treatment.
- •Patients are indicated for treatment under general anaesthesia due to polycaries / fear / anxiety / very young age.
- •Written consent is obtained from the parent/guardian after explaining the full details of the treatment procedure and its possible outcomes.
排除标准
- 未提供
研究组 & 干预措施
Biodentine
Pulpotomy using Biodentine as pulpotomy medicine.
干预措施: Biodentine pulpotomy (Drug)
White Mineral trioxide Aggregate (MTA)
Pulpotomy using white MTA as pulpotomy medicine.
干预措施: White MTA pulpotomy (Drug)
Tempophore
Pulpotomy using Tempophore as pulpotomy medicine in a control group.
干预措施: Tempophore pulpotomy (Drug)
结局指标
主要结局
Radiographic successes after pulpotomy.
时间窗: 12 months after pulpotomy.
Radiographic criteria: presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of periradicular radiolucency and no loss or break of lamina dura.
Clinical successes after pulpotomy.
时间窗: 12 months after pulpotomy.
Clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.
Clinical success after pulpotomy.
时间窗: 3 months after pulpotomy.
clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.
次要结局
未报告次要终点