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临床试验/NCT02887547
NCT02887547Unknown不适用

Biomarkers Expression in Gingival Crevicular Fluid and Accelerated Tooth Movement

University of Sao Paulo0 个研究点目标入组 25 人开始时间: 2016年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
25
主要终点
Inflammatory Cytokines ad Chemokines Detection Assay

研究概览

简要总结

Gingival Crevicular Fluid samples will be collected using periopapers after accelerated tooth movement technique, results will be assessed with biomarkers levels done using ELISA Assays

详细描述

For this prospective study, 22 individuals were selected, with skeletal discrepancies randomly divided into two groups: 1 - accelerated tooth movement technique (ATMT) and 2 - Control.

Orthodontic records done in two times, initial and preoperative; Gingival Crevicular Fluid samples will be collected using periopapers in 7 times (1, 2, 7, 14, 28 days and after space closure- end of orthodontic treatment movement activation).

Flapless cortical perforations will be made in ATMT Group after dental extraction. Surgical protocol will be flapless to preserve periodontal health.

After extraction space closure, results will be assessed by clinical effects with biological markers levels:

CCL3/MIP-1 alpha, CCL5/RANTES, CXCL8/IL8, IL-1 alpha, IL-1 beta, IL6, TNF-alpha, TRANCE/RANK L, OCN OPG IL-10 VEGF TGF-ℬ

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

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

  • Adult subjects ages 18-40 years old, in good general health, with adult complete dentition, regardless of presence of third molars.
  • Indication for orthognathic surgery
  • Tooth extraction indication for orthodontic treatment
  • Do not smoke
  • Periodontal and teeth healthy
  • Do not use bisphosphonates or corticosteroids

排除标准

  • Surgically assisted rapid palatal expansion indication
  • Cleft lip and palate
  • Craniofacial syndrome
  • Mental disorder
  • Metabolic diseases

研究组 & 干预措施

Control

No Intervention

Control group, with traditional orthodontic mechanics for anterior retraction. Crevicular fluid will be collected during anterior retraction mechanics to identified biomarkers in the inflammatory process

Acceleration

Experimental

Group with micro-osteoperforation for accelerated tooth movement during anterior retraction, Crevicular fluid will be collected during anterior retraction mechanics to identified biomarkers in the inflammatory process

干预措施: micro-osteoperforation (Procedure)

结局指标

主要结局

Inflammatory Cytokines ad Chemokines Detection Assay

时间窗: 8 months

Measure the different levels of listed cytokines and chemokines after starting the anterior retraction

Bone remodeling markers in GCF samples

时间窗: 8 monnths

Measure the different levels of resorption biomarkers and bone formation after starting the anterior retraction

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

LIANA FATTORI ABATI

MS, PhD

University of Sao Paulo

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