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临床试验/NCT03555747
NCT03555747已完成不适用

Molecular Analysis of Gingival Crevicular Fluid in Response to the Magnitude of Orthodontic Force: a Longitudinal Randomized Split-mouth Study

Aydin Adnan Menderes University0 个研究点目标入组 15 人开始时间: 2015年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
主要终点
Gingival crevicular fluid protein content change

研究概览

简要总结

The aim of this randomized split-mouth study was to quantify simultaneously 30 analytes including cytokines, chemokines and growth factors in gingival crevicular fluid (GCF) in response to different magnitudes of forces during maxillary canine distalization. The upper right and left canines were distalized using a continuous force of 75 g or 150 g in 15 individuals who had Class II division I malocclusion requiring bilateral extraction of maxillary first premolars. GCF samples were obtained from the tension and the pressure side of each canine at appliance placement and after force application at 24 hours and 28 days. A multiplexed bead immunoassay was used to quantify 30 analytes simultaneously. The effect of force, side and time on the analyte levels were analyzed with Brunner-Langer method.

详细描述

Patient selection:

Fifteen orthodontic patients with class II division I malocclusion, who required the extractions of maxillary first premolars bilaterally, distal canine movement, and maximum anchorage control as a part of fixed orthodontic treatment plan were invited to participate in the study. All subjects were in good general health with clinically and radiological healthy periodontal tissues (the probing depths ≤3 mm, full-mouth plaque and bleeding score ≤15%, and no bone loss radiographically). Patients were excluded if they were smokers, had had previous orthodontic treatment, had taken a course of anti-inflammatory drugs within 1 month and antimicrobial agents in the previous 3 months prior to the start of the study.

Experimental Design:

The first premolars were extracted at least 20 days prior to the distalization of the canines. Ten days prior to the application of orthodontic force all subjects underwent full-mouth scaling and oral hygiene instructions to ensure optimal plaque control and oral hygiene instruction was reinforced throughout the whole study period. In each patient, two mini-screw implants (1.5 mm in diameter and 8.0 mm in length) were placed bilaterally into the inter-radicular bone between the maxillary second premolar and first molar in the attached gingiva.The upper right and left canines of the same patient were randomly distalized using a continuous force of 75 or 150 g with nickel-titanium closed coil springs. Simple randomization by flipping a coin was used to determine the assignment of each site for two different forces.

GCF sampling:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
11 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Systemically healthy
  • Non-smoker
  • Orthodontic patients with class II division I malocclusion

排除标准

  • Orthodontic treatment history
  • Use of anti-inflammatory drugs within one month
  • Use of antibiotics within last three months

结局指标

主要结局

Gingival crevicular fluid protein content change

时间窗: Change from baseline to 24 hours and to 28 days after force application

pg/ml

次要结局

  • The amount of tooth movement(Change from baseline to 28 days after force application)
  • Probing pocket depth change(Change from baseline to 24 hours and to 28 days after force application)
  • Clinical attachment level change(Change from baseline to 24 hours and to 28 days after force application)

研究者

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

Beral Afacan

Assistant Professor

Aydin Adnan Menderes University

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