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临床试验/NCT05038865
NCT05038865招募中不适用

Oral Health Related Quality of Life - The Effect of Malocclusions, Gender, Socioeconomic Differences and Orthodontic Treatment Among Adolescents

Malmö University3 个研究点 分布在 1 个国家目标入组 675 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
675
试验地点
3
主要终点
Oral Health Related Quality of Life measured with Child Perceptions Questionnaire 11-14 short form- change before and after orthodontic treatment and at matched time points in an untreated population

研究概览

简要总结

Malocclusions in adolescents may affect oral health related quality of life. The study aims at;

  1. Evaluating two instruments measuring oral health related quality of life; "Child Perceptions Questionnaire 11-14" (CPQ 11-14) short form and "Psychosocial Impact of Dental Aesthetics Questionnaire" (PIDAQ).

  2. Comparing differences in oral health related quality of life in;

  3. adolescents with different types of malocclusion and without malocclusions

  4. individuals of different genders and socioeconomic status

  5. Longitudinally evaluating differences in oral health related quality of life;

  6. before, during and after orthodontic treatment

  7. in untreated individuals (without malocclusion) over time

详细描述

The individuals that are to be recruited to the study are;

Malocclusion group; 500 12-19 year olds with malocclusion, examined at their specialist orthodontic clinic.

No malocclusion group; 175 12-19 year olds without malocclusion, examined at their general dentistry clinic.

All patients will also answers two questionnaires (in Swedish) measuring oral health related quality of life; CPQ 11-14 short form (Jokovic 2006, Dimberg 2019) and PIDAQ (Klages 2006, Göranson 2020). Randomization will ensure that half of the study participants will begin with CPQ 11-14 short form and then PIDAQ, while half of the participants will answer the questionnaires in the reverse order. The questionnaires will be answered in a calm environment in the dental clinic.

All patients will have five standardized intraoral photographs taken. These photographs are already routinely taken at the specialist orthodontic clinics, but is taken in addition to routine procedure at the general dentistry clinic. To determine presence of malocclusion and orthodontic treatment need, two orthodontic indices will be used; ICON (Daniels 2000) and IOTN (Brook 1989). Assessments will be based on intraoral photographs, clinical measurements and pre-existing dental x-rays.

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
12 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescents 12-19 years of age with malocclusion (IOTN grade 4 and 5) referred to specialist orthodontic clinics
  • Adolescents 12-19 years of age without malocclusion (IOTN grad 1, 2 or 3) at general dentistry clinics

排除标准

  • Previous orthodontic treatment
  • Cleft lip and palate
  • ASA ≥ III
  • Intellectual and/or physical inability to answer questionnaires

结局指标

主要结局

Oral Health Related Quality of Life measured with Child Perceptions Questionnaire 11-14 short form- change before and after orthodontic treatment and at matched time points in an untreated population

时间窗: At start of study, 1 year after start of study, at study completion (an average of 2.5 years), 1 year after study completion

Child Perceptions Questionnaire (CPQ) 11-14 short form is a common instrument measuring Oral Health Related Quality of life (OHRQoL) in children and adolescents. It is a generic instrument, measuring all aspects of OHRQoL.

Oral Health Related Quality of Life measured with Psychosocial Impact of Dental Aesthetics Questionnaire - change before and after orthodontic treatment and at matched time points in an untreated population

时间窗: At start of study, 1 year after start of study, at study completion (an average of 2.5 years), 1 year after study completion

Psychosocial Impact of Dental Aesthetics (PIDAQ) is an instrument measuring orthodontic specific aspects of OHRQoL.

次要结局

未报告次要终点

研究者

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

Mikael Sonesson

Dr

Malmö University

研究点 (3)

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