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临床试验/NCT06693349
NCT06693349已完成3 期

Evaluation of Platelet-rich Fibrin for Revascularization of Im-mature Permanent Teeth Versus Standard Apexification: a 12-month Clinical Follow-up Study

Mohammed Nasser Alhajj1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2020年1月2日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

发起方
Mohammed Nasser Alhajj
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohammed Nasser Alhajj

Assistant Professor Dr. Mohammed Nasser Alhajj

Thamar University

研究点 (1)

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