Clinical and Radiographic Evaluation of Single-Versus Two-visit Pulpectomy in Primary Molars: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 主要终点
- Clinical and Radiographic outcomes
研究概览
简要总结
A total of 64 primary molars of 5-8 years old children will be randomly selected from Pediatric dental clinic at Faculty of Dentistry, Mansoura University.
Children will have two bilateral carious primary molars indicated for pulpectomy ; One side will be treated in one visit and the other will be treated in two visits.
Clinical and radiographic evaluation for 3 , 6, 12 months
详细描述
All the pulpectomy steps will be carried out by a single operator. After confirming the diagnosis clinically and radiographically, the necrotic tooth will be anesthetized by local anesthesia and isolated by rubber dam.
Caries will be removed by sterile round diamond burs. Proper access cavity will be prepared with complete deroofing and the pulp chamber will be irrigated by saline 0.9%. The working length will be established by apex locator and confirmed by periapical film (1 mm short of radiographic apex). Mechanical instrumentation will be done using rotary files followed by irrigation with no excessive pressure between files using sodium hypochlorite 2.5%. Then, root canal system will be dried by sterile paper points.
In case of single visit pulpectomy (21):
Root canals will be obturated by metapex and the tooth will be finally restored by glass ionomer filling and stainless-steel crown.
In case of two visit pulpectomy (13):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cooperative 5-8 years old children with no systemic diseases or chronic conditions. _Every child should have bilateral necrotic primary molars indicated for pulpectomy with sufficient coronal tooth structure.
排除标准
- •Children received antibiotics in the past month before the study. Primary molars with sinus tract, abscess, or facial cellulitis. Primary molas with root resorption exceeding one third of root length
研究组 & 干预措施
single visit
Necrotic primary molar treated in single visit
干预措施: Single and two visits pulpectomy (Procedure)
Two visits
Necrotic primary molar treated in two visits
干预措施: Single and two visits pulpectomy (Procedure)
结局指标
主要结局
Clinical and Radiographic outcomes
时间窗: 3 , 6 and 12 months
Proportion of clinical and radiographic success in both treatment protocols
次要结局
未报告次要终点
研究者
Moustafa Reda
Sherbin/Dakhlia/Egypt
Mansoura University