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

NCT07648121 | Completed

• 1 other identifier: CE-FMDUL202519
• Study Type: observational
• Target: 454
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Oral Health Related Quality of Life (OHRQoL); Early Childhood Caries (ECC); Traumatic Dental Injuries; Gingivitis; Malocclusion

Keywords

oral health related qualiry of life in preschool children

Outcome Measures

Primary Outcomes (1)

• Oral Health-Related Quality of Life

  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

Secondary Outcomes (5)

• Level of Oral Hygiene

  Baseline

• Gingival health

  Baseline

• Presence of caries

  Baseline

• Presence of malocclusion

  Baseline

• Presence of dental trauma

  Baseline

Other Outcomes (8)

• Psychosocial variables - Parental attitudes towards dental decay

  Baseline

• Psychosocial variables - Parental attitudes towards toothbrushing behaviour

  Baseline

• Psychosocial variables - Parental attitudes towards child sugar snacking

  Baseline

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Preschool-aged children attending schools in the district of Portalegre

You may qualify if:

• 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

Sponsors & Collaborators

• University of Lisbon: lead
• Universidade Nova de Lisboa: collaborator

Study Sites (1)

Faculty of Dental Medicine, University of Lisbon

Lisbon, Portugal

Location

MeSH Terms

Conditions

Gingivitis; Malocclusion

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Researcher

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 15, 2026
• Study Start: April 11, 2025
• Primary Completion: March 20, 2026
• Study Completion: March 20, 2026
• Last Updated: June 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)