Postoperative Pain Following Pulpectomy of Primary Molars With Rotary Instrumentation Versus Manual Instrumentation: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 主要终点
- Postoperative pain: modified wong-baker pain rating scale
研究概览
简要总结
One of the major concerns in pediatric dentistry is premature loss of necrotic primary teeth which may cause a deleterious effect on the growth of the facial skeletal complex. In order to sustain the primary tooth as a natural space maintainer, pulpectomy is considered the treatment of choice.
The essential part of endodontic treatment is to shape and clean the root canal effectively from infected tissue with microbial reduction, whilst maintaining the original configuration without creating any procedural errors . Even though, manual instrumentation as used for that purpose in deciduous teeth, presents some limitation concerning root canal cleaning, anatomical fidelity and chair-side time.
To achieve successful pulpectomy technique for the primary dentition in a fast and simple procedure, with short chair time as well as effective debridement of the root canals, rotary instrumentation is one of the methods recommended over the manual.
详细描述
- Trial design:
Randomized clinical trial, parallel groups design with 1:1 allocation ratio. 2. Method:
Interventions
A. Diagnostic procedure:
- Clinical examination will be done on the dental clinic using mirror and probe to assess the eligibility.
- Diagnosis of the cases will be performed according to guidelines of AAPD 2017 for treatment of vital pulp therapy in primary teeth.
- An individual XCP (Extension Cone Paralleling) index will be prepared for each patient by registering the bite to allow consistent comparisons of the radiographs.
- Preoperative periapical radiograph and photographs will be taken a baseline record.
B. Intra operative procedure:
- Local anesthesia administration using articaine 4% with epinephrine 1:100000.
- Rubber dam application and access cavity preparation will be established using a sterile bur.
- Coronal pulp tissue will be removed using sharp large spoon excavator.
- Working length will be determined using no 15 hand K-file that will be kept 2mm short of radiographic apex.
- Then, the root canal preparation will be done
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary posterior teeth requiring pulpectomy.
- •Cooperative patient in age range from 4 to 6 years
- •Absence of internal or external pathologic root resorption.
- •Presence of adequate coronal tooth structure.
- •Two-thirds of each root remaining.
- •Parent or guardian agree for participant in the study
排除标准
- •Excessive mobility.
- •Children lacking cooperative ability.
- •Children with underlying systemic disease.
- •Children with special health care needs.
研究组 & 干预措施
rotary instrumentation
endodontic treatment will be performed with the use of pedo rotary files that will be activated by engine
干预措施: Rotary instrumentation (Device)
hand istrumentation
endodontic treatment will be performed with the use of conventional hand files
干预措施: Hand instrumentation (Device)
结局指标
主要结局
Postoperative pain: modified wong-baker pain rating scale
时间窗: 72 hours
pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain.
postoperative pain: modified wong-baker pain rating scale
时间窗: 48 hours
pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain.
次要结局
- Tenderness to percussion(Up to 1 year)
- Fistula(Up to 1 year)
- Instrumentation time(15 Minutes)
- Furcation or periapical radiolucency(12 month)
研究者
Azhar Abdulrahman Ali Saleh Al-wesabi
phD student
Cairo University