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Assessment of Oral Health-Related Quality of Life in Preschool-Aged Children in Alto Alentejo

2026年6月13日 更新者:Cátia Sofia Pinheiro Serralha、University of Lisbon

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

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?

調査の概要

詳細な説明

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.

The examination followed a standardized sequence: assessment of oral hygiene status, recording of gingival health, toothbrushing with a disposable toothbrush, drying the teeth with gauze, and subsequent evaluation of dental caries, malocclusion, and traumatic dental injuries.

研究の種類

観察的

入学 (実際)

454

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Lisbon、ポルトガル
        • Faculty of Dental Medicine, University of Lisbon

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

はい

サンプリング方法

確率サンプル

調査対象母集団

Preschool-aged children attending schools in the district of Portalegre

説明

Inclusion Criteria:

  • 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

Exclusion Criteria:

-

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Oral Health-Related Quality of Life
時間枠: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.

Baseline

二次結果の測定

結果測定
メジャーの説明
時間枠
Presence of caries
時間枠:Baseline

For the diagnosis of dental caries, the procedures and criteria of ICDAS II were followed. The protocol described by this system recommended tooth brushing and drying prior to caries detection; therefore, the teeth were brushed with a disposable toothbrush and then dried with gauze. The system used two digits to record each tooth or surface: the first digit referred to restorations and sealants, and the second to the dental caries diagnosis. In this study, recording was performed per tooth, corresponding to the worst condition observed among its surfaces.

In the ICDAS II system, codes 1 and 2 record early non-cavitated caries. However, because data collection occurred in kindergarten settings without the possibility of drying teeth with compressed air, code 1 for smooth-surface lesions could not be used. As anticipated in ICDAS II guidelines for epidemiological studies, codes 1 and 2 were therefore combined and recorded as "A" in this study.

Assessed during the intraoral examination.

Baseline
Presence of malocclusion
時間枠:Baseline

The criteria for assessing malocclusion followed Bjork, Zhou, and Grippaudo. Malocclusion was classified into three groups: (1) occlusal anomalies (anterior crossbite, edge to edge bite, increased overjet, anterior open bite, deep bite, posterior crossbite, scissor bite); (2) space anomalies (crowding); and (3) dentition anomalies (supernumerary teeth, agenesis, malformations). Anterior crossbite, edge to edge bite, increased overjet, anterior open bite, and deep bite were determined using horizontal and vertical overlap measurements. Horizontal overlap was recorded as the greatest distance between maxillary and mandibular incisors parallel to the occlusal plane; vertical overlap was the greatest distance between their incisal edges.

Assessed during the intraoral examination.

Baseline
Presence of dental trauma
時間枠:Baseline
The criteria used to diagnose traumatic dental injuries were based on WHO recommendations. Teeth affected by dental trauma were coded as follows: 0 - No signs of injury; 1 - Treated injury; 2 - Enamel fracture only; 3 - Enamel and dentine fracture; 4 - Pulp involvement; 5 - Tooth loss due to trauma; 6 - Other damage; 9 - Tooth excluded Assessed during the intraoral examination.
Baseline
Level of Oral Hygiene
時間枠:Baseline

Oral hygiene was assessed using the soft debris component of the Simplified Oral Hygiene Index (OHI-S), following the criteria proposed by Rodrigues. For the primary dentition, the buccal surfaces of teeth 54, 61, and 82 and the lingual surface of tooth 75 were examined with a periodontal probe aligned parallel to the long axis of the tooth. If any of the indicated teeth were missing, the closest distal tooth was examined; if this tooth was also absent, the closest mesial tooth was assessed. Each tooth was assigned an integer score from 0 to 3, and the participant's final score was the mean of the values obtained.

Assessed during the intraoral examination.

Baseline
Gingival health
時間枠:Baseline

Gingival health was quantified using the ORI (Oral Rating Index), an oral classification index, following the criteria proposed by Kawamura. The ORI was based on the examination of four areas: the buccal surfaces of the maxillary anterior teeth, the buccal surfaces of the mandibular anterior teeth, the palatal surfaces of the right maxillary molars, and the lingual surfaces of the right mandibular molars. To determine each individual's ORI level, observable gingival characteristics and the accumulation of calculus and dental plaque were assessed, after which the individual was classified on an ordinal scale. The index was recorded without manual instruments, under natural light, and the decision was made within approximately 10 seconds. In cases of uncertainty, the examiner assigned the lowest score as the representative value for the individual.

Assessed during the intraoral examination.

Baseline

その他の成果指標

結果測定
メジャーの説明
時間枠
Psychosocial variables - Parental attitudes towards dental decay
時間枠:Baseline
The scale is composed of variables that correspond to factors included in the Parents' Beliefs and Attitudes Questionnaire. This scale assesses parents' beliefs and attitudes regarding the prevention of ECC, including perceived severity, perceived controllability, and external control. All items use the same response format: a 5-point Likert scale ('strongly agree', 'agree', 'neither agree nor disagree', 'disagree', 'strongly disagree'), scored from 1 to 5. Each variable score corresponds to the mean of the items within its respective factor, resulting in values ranging from 1 to 5. Lower scores indicate less positive beliefs and attitudes, whereas higher scores indicate more positive beliefs and attitudes. Assessment is performed at the moment when parents complete the questionnaire.
Baseline
Psychosocial variables - Parental attitudes towards toothbrushing behaviour
時間枠:Baseline
The scale is composed of variables that correspond to factors included in the Parents' Beliefs and Attitudes Questionnaire. This scale assesses beliefs and attitudes related to the child's toothbrushing and includes two variables: the importance and intention of brushing the child's teeth, and parents' self-efficacy regarding the child's toothbrushing. All items use the same response format: a 5-point Likert scale ('strongly agree', 'agree', 'neither agree nor disagree', 'disagree', 'strongly disagree'), scored from 1 to 5. Each variable score corresponds to the mean of the items within its respective factor, resulting in values ranging from 1 to 5. Lower scores indicate less positive beliefs and attitudes, whereas higher scores indicate more positive beliefs and attitudes. Assessment is performed at the moment when parents complete the questionnaire.
Baseline
Psychosocial variables - Parental attitudes towards child sugar snacking
時間枠:Baseline
The scale is composed of variables that correspond to factors included in the Parents' Beliefs and Attitudes Questionnaire. The scale of parents' beliefs and attitudes regarding the control of cariogenic diet includes the following variables: the importance and intention of controlling cariogenic food intake, and parents' self-efficacy related to the control of cariogenic diet. All items use the same response format: a 5-point Likert scale ('strongly agree', 'agree', 'neither agree nor disagree', 'disagree', 'strongly disagree'), scored from 1 to 5. Each variable score corresponds to the mean of the items within its respective factor, resulting in values ranging from 1 to 5. Lower scores indicate less positive beliefs and attitudes, whereas higher scores indicate more positive beliefs and attitudes. Assessment is performed at the moment when parents complete the questionnaire.
Baseline
Variables related to the habits and behaviors of the mother/father/caregiver
時間枠:Baseline

This group of variables gathers information on parents' behavior regarding access to oral health care and toothbrushing, namely: frequency of toothbrushing, dental attendance, and frequency of dental visits.

Assessed at the moment when parents complete the questionnaire.

Baseline
Variables related to the child's behaviors
時間枠:Baseline

This group of variables includes those related to the child's oral hygiene, eating behaviors, and sucking habits: frequency of toothbrushing, night-time toothbrushing, use of fluoridated toothpaste, adult supervision during toothbrushing, consumption of foods and/or drinks after night-time brushing, foods and/or drinks consumed after night-time brushing, frequency of consumption of cariogenic foods between main meals, frequency of fruit and/or vegetable consumption, pacifier use and thumb sucking.

Assessed at the moment when parents complete the questionnaire.

Baseline
Variables related to access to oral health care
時間枠:Baseline

This group of variables collects information on the child's use of oral health care services: dental attendance, frequency of dental visits, information received about the child's oral health care and source of information about the child's oral health care.

Assessed at the moment when parents complete the questionnaire.

Baseline
Variables related to general health
時間枠:Baseline

This group of variables refers to information on the child's general health status and the importance attributed to the child's general and oral health: classification of the child's general health, classification of the child's oral health status, importance of oral health for the child's general health, presence of a relevant health problem or disease and health problem or disease.

Assessed at the moment when parents complete the questionnaire.

Baseline
Sociodemographic variables
時間枠:Baseline

This group of variables refers to the collection of social, economic, and demographic data from the study participants: sex, age, type of kindergarten, number of people in the household, child's cohabitants, child's nationality, parents' nationality and mother's educational level.

Assessed at the moment when parents complete the questionnaire.

Baseline

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出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年4月11日

一次修了 (実際)

2026年3月20日

研究の完了 (実際)

2026年3月20日

試験登録日

最初に提出

2026年5月31日

QC基準を満たした最初の提出物

2026年6月10日

最初の投稿 (実際)

2026年6月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月16日

QC基準を満たした最後の更新が送信されました

2026年6月13日

最終確認日

2026年4月1日

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