Educational and Preventive Session for Dental CariesOHPPSPSNCT06797778
Oral Health Promotion Program in Schools in Polígono Sur
An observational study of Educational and Preventive Session for Dental Caries and Oral Diseases, run by University of Seville at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Educational and Preventive Session for Dental Caries, Oral Diseases
- How many people
- 396 participants
- Where
- 1 siteSpain
- Study dates
- 31 Mar 2023to Jun 2028
- How long will I take part?
- 6 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Preschool and primary school children in schools in Polígono Sur.
Who may be able to join
- Schoolchildren whose legal guardians agree to participate
Who cannot join
- Schoolchildren whose legal guardians do not consent to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of dental caries
Measured: pre-intervention and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start31 Mar 2023
- Primary completion23 Jun 2023
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational and Preventive Session for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 396 participants (estimated)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonia Domínguez Reyes, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797778
- Sponsor's protocol ID
- 0059-N23
- Acronym
- OHPPSPS
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Promotion Program in Schools in Polígono Sur
- ClinicalTrials.gov ID
- NCT06797778
- Acronym / sponsor ID
- OHPPSPS / 0059-N23
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 396 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- Jun 2028 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Preschool and primary school children in schools in Polígono Sur.
Key inclusion criteria (1 listed)
- Schoolchildren whose legal guardians agree to participate
Key exclusion criteria (1 listed)
- Schoolchildren whose legal guardians do not consent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of dental caries
Time frame: pre-intervention and immediately after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Educational and Preventive Session for Dental Caries and Oral Diseases, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of dental caries (time frame: pre-intervention and immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.