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临床试验/NCT04773210
NCT04773210Unknown不适用

Association Between Type of Ligating Brackets and Oral Health-related Quality of Life in Orthodontic Patients

Fundación Universitaria CIEO1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年4月12日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Oral health-related quality of life (OHRQoL)

研究概览

简要总结

To evaluate the association of the level of quality of life related to oral health, between treatment with the minitube system and conventional ligation brackets, in adult patients with moderate malocclusion, during the first six months, of orthodontic treatment.

详细描述

This is an observational cohort study with 1: 1 allocation ratio. The sample will be of 200 participants, divided into two groups. People over 18 years of age will be included; with moderate treatment complexity determined by Dental Aesthetics Index DAI. The study interventions are: (1) Mini tube system (FLOW-JAC System, Bogotá, Colombia) and (2) Conventional ligating brackets (Gemini 3M Unitek Orthodontic Products bracket, Calif, USA) with Nitinol Classic or superelastic (SE) archwires 0.014 and 0.016.

The outcome variable is Oral health-related quality of life (OHRQoL) measured with OHIP-S14 Ortho instrument, which was validated in Spanish in patients with orthodontic treatment. Consists of 14 questions that address seven dimensions (functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap), specifically related to orthodontic treatment. The OHIP-S14 Ortho score is between 0 to 56. Where 0 indicates a positive impact and 56 an unfavorable impact. The questionnaire will be self-administered online during the first 6 months of treatment: T0: prior to cementation, T1: 24 -48 hours after cementation, T2: 1 month after cementation, T3: 3 months after cementation and T4: 6 months after cementation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age range from 18 to 35
  • Moderate treatment complexity determined by Dental Aesthetics Index DAI moderate.
  • Orthodontic treatment with mini tube system in upper and lower jaw or MBT conventional ligating pre-set appliances
  • Non- extractions at the start of orthodontic treatment
  • Non- placement of mini-implants at the start of orthodontic treatment

排除标准

  • Craniofacial anomalies
  • Dental caries at the start of orthodontic treatment
  • Periodontal disease at the start of orthodontic treatment
  • Systemic disease
  • Orthognathic surgery indicated
  • Cognitive disorders
  • Non understand the Spanish language

结局指标

主要结局

Oral health-related quality of life (OHRQoL)

时间窗: Change from baseline to 6 months

Oral health-related quality of life (OHRQoL) measured with OHIP-S14 Ortho instrument, which was validated in Spanish in patients with orthodontic treatment.

次要结局

未报告次要终点

研究者

发起方
Fundación Universitaria CIEO
申办方类型
Other
责任方
Sponsor

研究点 (1)

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