NCT06797778

Brief Summary

The objective of this observational study is to evaluate oral health before and after conducting an educational session on oral hygiene in schoolchildren from 3 schools in the Polígono Sur of Seville. The main questions it aims to answer are:

  • To find out the needs of schoolchildren for oral treatment.
  • To analyse whether the educational sessions carried out serve to improve the oral health of schoolchildren. The researchers will compare the results of different academic years to see if it serves to improve. The participants are examined at the school during the school year. The educational sessions are carried out at the school during the school year.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
396

participants targeted

Target at P75+ for all trials

Timeline
25mo left

Started Mar 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress60%
Mar 2023Jun 2028

Study Start

First participant enrolled

March 31, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Expected
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

January 20, 2025

Last Update Submit

January 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of dental caries

    pre-intervention and immediately after the intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Preschool and primary school children in schools in Polígono Sur.

You may qualify if:

  • Schoolchildren whose legal guardians agree to participate

You may not qualify if:

  • Schoolchildren whose legal guardians do not consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Sevilla

Seville, Sevilla, 41009, Spain

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
6 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor Faculty of Dentistry

Study Record Dates

First Submitted

January 20, 2025

First Posted

January 28, 2025

Study Start

March 31, 2023

Primary Completion

June 23, 2023

Study Completion (Estimated)

June 1, 2028

Last Updated

January 28, 2025

Record last verified: 2025-01

Locations