Evaluation of Platelet-rich Fibrin for Revascularization of Im-mature Permanent Teeth Versus Standard Apexification: a 12-month Clinical Follow-up Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Radiographic measurements of the change in the canal space
研究概览
简要总结
The goal of this clinical trial is to evaluate the effect of platelet-rich fibrin for revascularization of immature permanent teeth in comparison to standard apexification using calcium hydroxide (as a 12 months follow up for previous study) through using clinical outcomes and radiographically using cone beam computed tomography the main questions it aims to answer are
- is the platelet-rich fibrin an effective mean for management of necrotic immature permanent teeth
- is the platelet-rich fibrin has a superior clinical and radiographic effects than calcium hydroxide apexification participants were treated either by platelet-rich fibrin revascularisation or calcium hydroxide apexification
详细描述
This study is an extension of a previous study [12], encompassing a 12-month fol-low-up period. The protocol for this study received approval from the ethical committee of the Faculty of Dentistry at Mansoura University (11111218) as a randomized con-trolled-clinical trial with a 1:1 allocation ratio for groups and subgroups. The sample size for this study was calculated based on Nagy et al.'s study [13], which determined a re-quired sample size of 28 teeth.
Inclusion and diagnostic criteria:
A total of 28 children, including both boys and girls, were recruited through daily pa-tient screenings in the Clinics of Pediatric Dentistry and dental public health department, Faculty of Dentistry at Mansoura University, following specific inclusion and diagnostic criteria:
- Patients were free of chronic systemic diseases.
- Clinically, a negative response to electric pulp sensibility testing confirmed the pres-ence of immature necrotic permanent teeth.
- Teeth were categorized as uncontaminated if, during the examination, there were no signs of pain, no tenderness during apical percussion, no tenderness of adjacent soft tissues, and no history of open sinus, fistula or swelling.
- Radiographically, teeth were with roots exhibiting thin dentin walls and open apical foramina larger than 1 mm, along with apical periodontitis (considered as contami-nated) or without apical periodontitis (considered as uncontaminated).
Patients' allocation:
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 (Participant)
入排标准
- 年龄范围
- 7 Years 至 13 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients were free of chronic systemic diseases.
- •Clinically, a negative response to electric pulp sensibility testing confirmed the pres-ence of immature necrotic permanent teeth.
- •Teeth were categorized as uncontaminated if, during the examination, there were no signs of pain, no tenderness during apical percussion, no tenderness of adjacent soft tissues, and no history of open sinus, fistula or swelling.
- •Radiographically, teeth were with roots exhibiting thin dentin walls and open apical foramina larger than 1 mm, along with apical periodontitis (considered as contami-nated) or without apical periodontitis (considered as uncontaminated).
排除标准
- •other than inclusion criteria
研究组 & 干预措施
Contaminated immature permanent teeth
treatment of contaminated immature permanent teeth through either revascularization or apexification procedures
干预措施: the effect of platelet-rich fibrin in treatment of contaminated and uncontaminated immature permanent teeth (Drug)
Contaminated immature permanent teeth
treatment of contaminated immature permanent teeth through either revascularization or apexification procedures
干预措施: the effect of apexification in treatment of contaminated and uncontaminated immature permanent teeth (Drug)
uncontaminated immature permanent teeth
treatment of uncontaminated immature permanent teeth through either revascularization or apexification procedures
干预措施: the effect of platelet-rich fibrin in treatment of contaminated and uncontaminated immature permanent teeth (Drug)
uncontaminated immature permanent teeth
treatment of uncontaminated immature permanent teeth through either revascularization or apexification procedures
干预措施: the effect of apexification in treatment of contaminated and uncontaminated immature permanent teeth (Drug)
结局指标
主要结局
Radiographic measurements of the change in the canal space
时间窗: 16 months
Radiographic measurements of the change in the canal space, including an increase in root length and thickness, and reduction in a diameter of the apical foramen, were conducted using the CBCT
次要结局
未报告次要终点
研究者
Mohammed Nasser Alhajj
Assistant Professor Dr. Mohammed Nasser Alhajj
Thamar University
