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临床试验/NCT03399760
NCT03399760已完成不适用

Evaluation the Dento-alveolar Changes After Platelet Rich Fibrin (i-PRF) Injection During Upper Canine Retraction Using Cone-beam Computed Tomography (CBCT)

Damascus University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年8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
已完成
入组人数
20
试验地点
2
主要终点
Canine root resorption

研究概览

简要总结

Twenty patients need therapeutic extraction of the maxillary first premolars with subsequent retraction of the maxillary canines, will be divided randomly into two groups, and will randomly assigned to one side of the maxillary arch at the first premolar region, and the other side served as the control. Canine retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side. Soldered transpalatal arch will be used as an anchor unit. The dento-alveolar changes will be assessed immediately before retraction and after 6 months using CBCT.

详细描述

Extraction is a procedure that is currently performed in orthodontics, either in the context of early treatment or for adolescents with severe crowding or protrusion/overjet. The consequences of this ''simple'' procedure may show up many mucosal and osseous complications such as: bone resorption with collapse of the alveolar process, a gingival cleft or gingival recession in the area surrounding the extraction site. Besides the potential esthetic repercussions, these periodontal defects also give rise to a clinical problem with achieving some orthodontic movements, such as complete closure of the space or uprighting a root.

A systematic review evaluating alveolar bone dimension changes of extraction sockets showed a range of width reduction of 2.6-4.6mm, Two-thirds of the loss occurred in the first 3 months, the remodeling of alveolar bone in the extraction site always decreases ridge volume and deforms the ridge configuration which impairs orthodontic movement of the tooth posteriorly.

Endogenously produced biologicals have been tested based on their roles in the turnover of alveolar bone in response to orthodontic tooth movement as well as during wound healing.

From here it has been thought about using a method to enhance bone quality after extraction. The platelet rich fibrin (PRF) has the ability to enhance tissue regeneration, accelerate wound healing and inducing stem cells differentiation through its growth factors (GFs).

PRF characteristics in comparison to platelet rich plasma PRP are:

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

One blinded

入排标准

年龄范围
15 Years 至 27 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adult healthy patients, Male and female, Age range: 15-27 years.
  • Class II Division 1 malocclusion:
  • Mild / moderate skeletal Class II (ANB ≤7)
  • Overjet ≤10
  • Normal or excessive facial height (Clinically and then cephalometry assessed using these angles : SN-MP , MM , Y axis)
  • Mild to moderate crowding ≤ 4
  • permanent occlusion.
  • Exist all the upper teeth (except third molars).
  • Good oral and periodontal health:
  • Probing depth < 4 mm
  • No radiographic evidence of bone loss.
  • Gingival index ≤ 1
  • Plaque index ≤ 1

排除标准

  • Medical problems that affect tooth movement (corticosteroid, NSAIDs, ...)
  • patients have anti indication for oral surgery ( medical - social - psycho)
  • Presence of primary teeth in the maxillary arch
  • Missing permanent maxillary teeth (except third molars).
  • Poor oral hygiene or Current periodontal disease:
  • Probing depth ≥ 4 mm
  • radiographic evidence of bone loss
  • Gingival index > 1
  • Plaque index > 1
  • Patient had previous orthodontic treatment
  • Craniofacial anomalies (cleft lip and palate patients)
  • coagulation disorders and patients treated with anticoagulants.
  • patients with immunodeficiency disorders

研究组 & 干预措施

i-PRF assisted upper canine retraction

Experimental

I-PRF assisted upper canine retraction will be performed in one side of patients with Class II Division 1 malocclusion patients requiring therapeutic extraction of the maxillary first premolars

干预措施: i-PRF (Biological)

i-PRF assisted upper canine retraction

Experimental

I-PRF assisted upper canine retraction will be performed in one side of patients with Class II Division 1 malocclusion patients requiring therapeutic extraction of the maxillary first premolars

干预措施: canine retraction (Procedure)

conventional upper canine retraction

Experimental

Conventional upper canine retraction will be performed in the other side of patients with Class II Division 1 malocclusion patients requiring therapeutic extraction of the maxillary first premolars

干预措施: canine retraction (Procedure)

结局指标

主要结局

Canine root resorption

时间窗: After 6 months from the beginning of canine retraction

Root length measurement from a reference line between buccal and palatal cemento-enamel junction (CEJ) to apex. These lines are perpendicular to the long axis of the canine. The levels of CEJ and root apex were assessed using a combination of axial, sagittal, and coronal images.

次要结局

  • Alveolar bone height in the first premolar region(After 6 months from the beginning of canine retraction)
  • Bone density(After 6 months from the beginning of canine retraction)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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