Oral Health Promotion Program in Schools in Polígono Sur | NCT06797778

Studies
Oral Health Promotion Program in Schools in Polígono Sur

NCT06797778

Sponsor

University of Seville

Status

Enrolling by invitation

Last Update Posted

Jan 28, 2025Actual

Enrollment

396Estimated

Phase

Not provided

Conditions

Educational and Preventive Session for Dental Caries
Oral Diseases

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 31, 2023Actual

Primary Completion Date

Jun 23, 2023Actual

Completion Date

Jun 2028Estimated

First Submitted Date

Jan 20, 2025

First Submission Date that Met QC Criteria

Jan 27, 2025

First Posted Date

Jan 28, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2025

Last Update Posted Date

Jan 28, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Antonia Domínguez Reyes, Full Professor Faculty of Dentistry, University of SevillePrincipal Investigator

Lead Sponsor

University of SevilleOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

396Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of dental caries		pre-intervention and immediately after the intervention

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Schoolchildren whose legal guardians agree to participate

Exclusion Criteria:

Schoolchildren whose legal guardians do not consent to participate

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Preschool and primary school children in schools in Polígono Sur.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidad de Sevilla		Seville	Sevilla	41009	Spain