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临床试验/NCT03407261
NCT03407261已完成不适用

OHRQoL Assessment Between Sliding Anterior Retraction and Micro-osteoperforations for Accelerated Orthodontics in Patients Who Were Assigned for Pre-molar Extraction and Decompensation

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2017年6月15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
22
试验地点
2
主要终点
Comparision of OHRQoL between groups - OHIP-14A

研究概览

简要总结

OHRQoL assessment using OHIP-14 between sliding anterior retraction with self-ligating brackets and micro-osteoperforations for accelerated orthodontics in orthognathic surgery patients who were assigned for pre-molar extraction and decompensation

详细描述

Our patients are participants in a randomized clinical trial, an ongoing study about the effectiveness of micro-osteoperforations to accelerate tooth movement. The study sample consisted of 22 consecutive subjects - 12 females and 10 males - between the ages of 18 and 35, who were selected for ortho-surgical treatment and pre-molar extraction assigned for decompensation. The participants were randomly allocated to two groups: control (anterior retraction was performed using implant-assisted sliding mechanics with self-ligating brackets) and experimental (micro-osteoperforations were performed in the activation appointments for anterior retraction using implant-assisted sliding mechanics). For immediate and follow-up assessment of patients' perceptions, comparing regular orthodontic activation and activation with Accelerated Orthodontics, subjects were asked to complete an electronic questionnaire OHIP-14, to assess the participants' comfort level, experiences, and QoL impact.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • maxillomandibular discrepancy indicative for orthognathic surgery, no previous dental extractions, good oral and general health, non-smokers, and no use of systemic corticosteroids or biphosphonates

排除标准

  • any tooth absence/previous tooth extraction

研究组 & 干预措施

Micro-osteoperforations

Experimental

Minimally invasive micro-osteoperforations procedure used to achieve accelerated orthodontic tooth movement. Topical and local anesthetic will be delivered in the area to be treated in accordance with standard practice

干预措施: micro-osteoperforations (Procedure)

Control

No Intervention

Anterior retraction after premolars extraction will be done conventionally (sliding mechanics)

结局指标

主要结局

Comparision of OHRQoL between groups - OHIP-14A

时间窗: 4 days

comparision of OHIP-14A results between groups after appointment for anterior retraction: The sum of the numeric scores for each participant in all 14 items, with a maximum score of 56 (4x14);

Comparision of OHRQoL between groups - 7 domains

时间窗: 4 days

comparision of each OHIP-14 domain results between groups after appointment for anterior retraction: To evaluate which domains had the most impact during the trial, the answers for each question were combined as pairs and summed for statistical analysis.

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

PhD student

University of Sao Paulo

研究点 (2)

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