Clinical Effectiveness of Single Rotary File Versus Multiple Rotary Files in Pulpectomy of Primary Molars : A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- instrumentation time
研究概览
简要总结
The aim of this study is to compare the clinical effectiveness of a single rotary file system versus a multiple rotary files system in pulpectomy of primary molars
详细描述
In pediatric dentistry, premature loss of necrotic primary molars has been a matter of great concern over the years.
In modern pedodontic practice, Pulpectomy is regarded as the choice modality of treatment for pulpally involved necrotic teeth.
Hand files are used for mechanical preparation of primary tooth during pulpectomy but it has been found to be time consuming and may negatively influence the child's behavior . Much attention has been directed toward making pulpectomy a less time-consuming and a more-efficient procedure.
These challenges lead to the introduction of rotary endodontics in pediatric dentistry. However, the bizarre root canal morphology and thinner root dentin limited the use of rotary endodontics in primary teeth. Various modified protocols have been introduced to overcome such barriers to prevent undesirable complications.
Up to our knowledge, no clinical trials in the literature have been done to compare the clinical and radiographic success of single rotary file systems versus multiple rotary files systems when used in pulpectomy of primary molars. Thus, the present study aims to investigate the clinical effectiveness of those two techniques
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)
盲法说明
The blinding of the operator is not possible due to the nature of the technique used. Trial participants, outcome assessors and statistician will be blinded
入排标准
- 年龄范围
- 4 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children Criteria:
- •Medically free .
- •Cooperative patient.
- •Molar criteria :
- •Mandibular second primary molar with clinical signs or symptoms of irreversible pulpitis
- •Radiographic criteria:
- •No evidence of internal/external pathologic root resorption.
- •With or without periapical or furcal lesion .
排除标准
- •• Uncooperative children.
- •Children with systemic disease.
- •Lack of informed consent by the child patient's parent.
- •Refusal of participation.
研究组 & 干预措施
Group I ( pulpectomy using single rotary file )
After opening the access cavity, a single rotary file (20 taper 4) will be adjusted on the desirable working length depending on a radiograph (1 mm shorter than the apex) and used in pulpectomy in a brushing motion at the rotational speed 300 rpm with torque set at the lowest level, irrigation with saline
干预措施: Fanta AF blue rotary files 20 taper 4 (Device)
Group II ( pulpectomy using multiple rotary files system )
After opening the access cavity, multiple rotary files system (Fanta AF baby rotary files 20 taper 4, 25 taper 4, 30 taper 4) will be adjusted on the desirable working length depending on a radiograph (1 mm shorter than the apex) and used in pulpectomy in a brushing motion at rotational speed 300 rpm with torque set at the lowest level, irrigation with saline
干预措施: Fanta AF baby rotary files 20 , 25 , 30 taper 4 (Device)
结局指标
主要结局
instrumentation time
时间窗: during the operation
instrumentation time of pulpectomy using single rotary file by stopwatch
次要结局
- obturation quality(immediately after the operation)
- child's cooperation level(baseline and during the operation)
研究者
Mennat-Allah Eid Ahmed Elsayed
doctor , internal resident
Cairo University