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临床试验/NCT06302296
NCT06302296招募中不适用

Evaluating the Effect of Injectable Platelet-rich Fibrin on Accelerating Orthodontic Tooth Movement During Leveling and Alignment Stage Study Description

Hama University1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2025年12月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
14
试验地点
1
主要终点
Leveling and alignment maxillary incisors

研究概览

简要总结

One of the main goals of orthodontic treatment is the reduction of treatment time through faster tooth movement. The previous studies evaluating platelet-rich fibrin (PRF) and orthodontic tooth movement (OTM) are limited, which makes the results difficult to generalize.

详细描述

One of the main goals of orthodontic treatment is the reduction of treatment time through faster tooth movement. The previous studies evaluating platelet-rich fibrin (PRF) and orthodontic tooth movement (OTM) are limited, which makes the results difficult to generalize. To this end, we set up this Randomized experiment to evaluate the effect of the injectable form of PRF (i-PRF) on OTM, using nonadditive containing i-PRF, which has higher levels of regenerative cells and growth factors compared with other PRF types because of the use of low centrifugation spee. Accordingly, we aimed to evaluate the effect of i-PRF on the rate of maxillary incisors leveling during comprehensive orthodontic treatment.

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
18 Years 至 26 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The patient's age (18-26). Severe or very severe irregularity of the upper incisors greater than (7 mm) according to Little's index, so it is recommended to extract the upper first premolar.
  • Class I or Class II malocclusion, first model according to Angle, with skeletal class I or II and a normal or mild vertical growth pattern.
  • All permanent upper teeth, up to the first molar, are present, with the possibility of attaching brackets to all teeth in a correct position.
  • The patient has good oral health.

排除标准

  • • The presence of any systemic disease that affects orthodontic dental movement.
  • Severe malalignment of one of the teeth (palatal quadrant, ectopic canine, ectopic premolar).
  • The patient has undergone previous orthodontic treatment.
  • The patient is subject to any drug treatment that may affect orthodontic dental movement (cortisone, non-steroidal anti-inflammatory drugs).
  • The patient has poor oral health.
  • Commitment to periodic follow-up appointments.

研究组 & 干预措施

injectable form of PRF

Experimental

A group of patients in which participants will be undergo to orthodontic treatment will be received a 0.9 ml injection of PRF after 1st premolar extraction.

干预措施: injectable form of PRF (Device)

traditional orthodontic treatment

Experimental

A group of patients in which participants will be undergo to traditional orthodontic treatment will be received a Placebo injection after 1st premolar extraction.

干预措施: Placebo injection (Behavioral)

结局指标

主要结局

Leveling and alignment maxillary incisors

时间窗: One month ,two month,six month

\- Alginate impressions were taken at insertion of the first archwire (0.014-in nickel-titanium) maxillary incisors Leveling and alignment. Leveling and alignment were achieved through the following sequence of archwires: 0.014-in nickel-titanium (NiTi), 0.016 × 0.022-in NiTi, 0.017 × 0.025-in NiTi, 0.019 × 0.025-in stainless steel (SS)(3).

次要结局

未报告次要终点

研究者

发起方
Hama University
申办方类型
Other
责任方
Principal Investigator
主要研究者

FADI JNAID

Syria-Hama University

Hama University

研究点 (1)

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