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临床试验/NCT07648121
NCT07648121已完成不适用

Oral Health-Related Quality of Life in a Preschool Population of Alto Alentejo

University of Lisbon1 个研究点 分布在 1 个国家目标入组 454 人开始时间: 2025年4月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
454
试验地点
1
主要终点
Oral Health-Related Quality of Life

研究概览

简要总结

The observational study aims to improve understanding of Oral Health-Related Quality of Life (OHRQoL) among preschool children in the District of Portalegre, Portugal, by examining the roles of sociodemographic, behavioral, and parental psychosocial factors, as well as the child's oral health status.

The study seeks to answer the following main research question: How do sociodemographic, behavioural, parental psychosocial factors, and the child's oral health status influence the Oral Health-Related Quality of Life (OHRQoL) of preschool children in the District of Portalegre?

详细描述

This observational, analytical, and cross-sectional study aims to deepen understanding of the factors associated with Oral Health-Related Quality of Life (OHRQoL) among preschool children in the Portalegre District.

For participant selection, a probabilistic, multi-stage sampling process, stratified by type of preschool (public or private) and by municipality, was used. The final sample comprises 33 preschools, including 22 public and 11 private.

Data collection comprises two complementary components: a questionnaire completed by parents or caregivers and an intraoral examination for each participating child. The questionnaire comprises seven sections with multiple-choice and open-ended items. It collects information on the child's general health, access to oral healthcare, child and caregiver behaviors, OHRQoL, parental beliefs and attitudes regarding oral health, and sociodemographic characteristics. Distribution is carried out by educators and assistants from the institutions, ensuring delivery to parents or caregivers.

The intraoral examination collected data on oral hygiene, gingival health, the presence of dental caries, malocclusion, and traumatic dental lesions. All records were documented on a standardised form developed for the study. Examinations were carried out in a schoolroom with good natural and artificial lighting, using existing furniture. All infection control and cross-contamination prevention measures were implemented, including the use of disposable gloves and masks, as well as sterilized instruments.

The instruments used included a LED headlight, a flat intraoral mirror, a millimetre ruler, and a CPI (Community Periodontal Index) periodontal probe, in accordance with World Health Organization specifications, with a 0.5 mm ball tip.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
3 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All children who attended the selected classrooms were included in the study and who:
  • Were between 3 and 5 years of age at the time of the observation;
  • Had informed consent provided by their parents or legal guardians;
  • Assented to participate in the study

排除标准

  • 未提供

结局指标

主要结局

Oral Health-Related Quality of Life

时间窗: Baseline

The OHRQoL of preschool children will be assessed using the Early Childhood Oral Health Impact Scale (ECOHIS), included in the parent questionnaire. ECOHIS has 13 items: 9 evaluating the impact of oral problems on the child (Child ECOHIS) and 4 evaluating the impact on the family (Family ECOHIS). The child subscale includes four domains (symptoms, function, psychology, and social interaction), while the family subscale includes parental distress and family function. Items use a Likert scale from 0 ("Never") to 4 ("Very often"), with a "Don't know" option treated as missing. Participants with ≥2 "Don't know" responses in the child subscale or ≥1 in the family subscale will be excluded. The total ECOHIS score ranges from 0-52, with child and family scores ranging from 0-32 and 0-16. Higher scores indicate a more negative impact. Assessed at the moment when parents complete the questionnaire.

次要结局

  • Level of Oral Hygiene(Baseline)
  • Gingival health(Baseline)
  • Presence of caries(Baseline)
  • Presence of malocclusion(Baseline)
  • Presence of dental trauma(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cátia Sofia Pinheiro Serralha

Doctoral Researcher

University of Lisbon

研究点 (1)

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