Oral Health Education for Pregnant Women

February 11, 2026 updated by: Montserrat Catalá Pizarro, University of Valencia

Knowledge of Oral Health in Pregnant Women: Effect of a Short Educational Intervention

The goal of this research is to investigate oral health knowledge in pregnant women receiving care at Hospital La Fe and to see whether a one-time informational intervention improves this knowledge. The main questions this research aims to answer are:

What is the level of oral health knowledge among pregnant women attending Hospital La Fe?

Does a one-time informational intervention, delivered through a printed leaflet, improve oral health knowledge during pregnancy?

What factors are related to differences in oral health knowledge among pregnant women?

Participants are pregnant women receiving care at Hospital La Fe. They will:

Complete a questionnaire about their oral health knowledge.

Receive a printed informational leaflet about oral health during pregnancy.

Complete the same questionnaire again after a period of time to see if their knowledge has changed.

Researchers will compare answers before and after the leaflet is provided to see whether oral health knowledge improves. They will also explore which personal or social factors are linked to different levels of oral health knowledge.

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women aged 18-45 who have recently given birth to healthy babies, either vaginally or by cesarean section.
  • Ability to understand and speak Spanish.

Exclusion Criteria:

  • Complications during pregnancy or delivery.
  • Newborns with major birth defects.
  • Participants who do not provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Pregnant Women Receiving an Informational Leaflet
A printed informational leaflet is developed with two sections: "For Mothers" and "About the Baby," following international pediatric dentistry recommendations. A pilot study tests the clarity and completion time of the questionnaires. Participants are informed about the study, sign the consent form, and complete an initial questionnaire about oral health knowledge during their hospital visit. They receive the leaflet and complete the same questionnaire again after a period of time to assess changes. Most follow-up questionnaires are conducted by phone.
The intervention consists of a printed informational leaflet for pregnant women. The leaflet has two sections: "For Mothers," which explains oral health care during pregnancy, and "About the Baby," which provides oral health recommendations for the newborn. The content is based on recommendations from international and national pediatric dentistry associations (AAPD, EAPD, ALOP, SEOP). Participants read the leaflet during their hospital visit and take it home for reference. The leaflet aims to improve participants' knowledge, attitudes, and practices regarding oral health during pregnancy and in the first years of the child's life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Oral Health Knowledge, Attitudes, and Practices
Time Frame: From the date of administration of the first questionnaire (February 2026) to the date of completion of the second questionnaire following the intervention, assessed up to 39 weeks.
Participants complete a questionnaire about oral health knowledge, attitudes, and practices during pregnancy and in the first years of the child's life. The difference between baseline and follow-up scores is analyzed to assess whether the informational leaflet improves knowledge, attitudes, and practices.
From the date of administration of the first questionnaire (February 2026) to the date of completion of the second questionnaire following the intervention, assessed up to 39 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2026

Primary Completion (Estimated)

May 14, 2026

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

February 3, 2026

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2021-784-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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