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临床试验/NCT04611984
NCT04611984已完成不适用

Osteocalcin and Cross-Linked C-Terminal Telopeptides of Type I Collagen in Gingival Crevicular Fluid During Piezocision Accelerated Orthodontic Tooth Movement

Marmara University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Gingival crevicular fluid osteocalcin level (ng/ml)

研究概览

简要总结

The aim of this study was to evaluate the tooth movement with and without piezocision with regard to the levels of osteocalcin and cross-linked C-terminal telopeptides of type I collagen in the gingival crevicular fluid.

详细描述

15 systemically healthy subjects requiring extraction of the maxillary 1. premolars with distalization of the maxillary canines were enrolled to the study. Piezocisions were performed on the distal and mesial sides of the right maxillary canines while the left maxillary canines served as controls. Canine distalization was performed via closed-coil springs applying 150 g of force per side by using miniscrews as anchorage. Gingival crevicular fluid samples were collected from both mesial and distal sides of right and left maxillary canines at 0, 1, 7, 14 and 28 days. The gingival crevicular fluid levels of osteocalcin and cross-linked C-terminal telopeptides of type I collagen were determined by using ELISA. The rate of tooth movement was measured on 14 and 28 days.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The investigators performing the clinical and surgical procedures, and patients were not blinded. Data assessment was performed by a blinded researcher. Gingival crevicular fluid samples were collected and numbered by another blinded researcher.

入排标准

年龄范围
13 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Class I, Class II or Class III malocclusion,
  • Proclined incisors requiring extraction of the maxillary first premolars with subsequent retraction of the maxillary canines
  • No previous orthodontic treatment
  • Good oral hygiene and periodontal health (plaque and gingival indices less or equal 1, probing depth less or equal 3 mm, no radiographic bone loss).

排除标准

  • having systemic diseases that could affect bone and tooth movement

结局指标

主要结局

Gingival crevicular fluid osteocalcin level (ng/ml)

时间窗: 28 days after canine distalization

Gingival crevicular fluid samples were collected from mesial and distal sides of the maxillary right and left canines.The gingival crevicular fluid level of osteocalcin was determined by using ELISA

Gingival crevicular fluid cross-linked C-terminal telopeptides of type I level (ng/ml)

时间窗: 28 days after canine distalization

Gingival crevicular fluid samples were collected from mesial and distal sides of the maxillary right and left canines.The gingival crevicular fluid level of cross-linked C-terminal telopeptides of type I collagen was determined by using ELISA.

次要结局

  • The amount of canine movement (mm)(Baseline (day 0) before canine distalization and, 14 and 28 days after canine distalization)
  • Retraction rate (mm/day) of canine movement(14 and 28 days after canine distalization)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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