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临床试验/NCT06198322
NCT06198322招募中不适用

Assessment of the Effects of Platelet-rich Fibrin and Vitamin Dꝫ Injections on Root Resorption: A Randomized Controlled Clinical Trial

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2023年5月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
14
试验地点
1
主要终点
- Assess the effect of using PRF and vitamin Dꝫ injections on root resorption and length and compare them by using CBCT.

研究概览

简要总结

This study aims to investigate and compare the effect of PRF and vitamin Dꝫ injections on root resorption by using CBCT

详细描述

  • Participants will be recruited from the Faculty of Dentistry, Beni-Suef University. All subjects will be informed of the treatment procedures and will sign a consent form.
  • Subjects will be randomly divided into two groups:

Group 1 (PRF group): upper canine retraction will be facilitated by PRF injection that will be randomly assigned to one side (experimental side). The contralateral side will serve as the control one.

Group II (Vitamin Dꝫ group): canine retraction will be facilitated by Vitamin Dꝫ injection that will be randomly assigned to one side (experimental side). The contralateral side will serve as the control one.

  • The predicted sample size (n) was a total of (28) cases (i.e. 14 cases per group). Sample size calculation was performed using G*Power version 3.1.9.7
  • Randomization:

Simple randomization will be designed with the aid of a computer-generated schedule with 1:1 allocation ratio. Allocation concealment will be achieved using identical opaque, sealed envelopes. Randomization and allocation concealment will be performed by one of the academic staff who will not be involved in the study and will keep the allocation table away from the operators. The operator will shuffle the sealed envelopes and will ask the patient to pick one envelope at the time of recruitment. In each group, a randomly selected side will act as the experimental side while the contralateral side will serve as the control. Blinding of the operators will not be applicable and so blinding will be limited to the outcome assessment.

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)

盲法说明

Single-blinded limited to the outcome assessment

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

- Assess the effect of using PRF and vitamin Dꝫ injections on root resorption and length and compare them by using CBCT.

时间窗: 3 - 4 months

Cone beam computed tomography (CBCT) will be obtained before treatment and after canine retraction to evaluate the severity of root resorption associated with the two techniques.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rehab Abd El Razek Abd El Aziz Khalil

Lecturer of Orthodontics

Beni-Suef University

研究点 (1)

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