KnowledgeNCT07413393
Oral Health Education for Pregnant Women
A study testing Informational Leaflet in people with Knowledge and Oral Health, run by University of Valencia at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Knowledge, Oral Health, Pregnant Women
- What is being tested?
- Informational Leaflet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2026to 29 Jul 2026
- Phase
- Interventional
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-45 who have recently given birth to healthy babies, either vaginally or by cesarean section.
- Ability to understand and speak Spanish.
Who cannot join
- Complications during pregnancy or delivery.
- Newborns with major birth defects.
- Participants who do not provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario La Fe
Valencia, Valencia, 46021
Montserrat CP Dr. Catalá, +34 961244000, montserrat.catala@uv.es
About this study
Official title: 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?
Read more
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.
- Conditions
- Knowledge, Oral Health, Pregnant Women, Intervention
- Being tested
- Informational Leaflet
- Keywords
- oral health, knowledge, pregnant, improvement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informational LeafletOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women Receiving an Informational Leaflet | Other | 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. Receives: Other: Informational Leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oral Health Knowledge, Attitudes, and Practices
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start15 Feb 2026
- Primary completion14 May 2026
- Study completion29 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KnowledgeStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Montserrat Catalá Pizarro, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413393
- Sponsor's protocol ID
- 2021-784-1
- Status last verified
- Jun 2026
- First submitted
- 3 Feb 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aznar-Marin A, Casana-Ruiz MD, Marcos-Puig B, Vello-Ribes MA, Perales-Marin A, Catala-Pizarro M. Knowledge of Oral Health in Pregnant and Puerperal Women: Effect of a Short Educational Intervention. Dent J (Basel). 2026 Oct 19;14(10):683. doi: 10.3390/dj14100683.
PubMed 42930449
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge of Oral Health in Pregnant Women: Effect of a Short Educational Intervention
- ClinicalTrials.gov ID
- NCT07413393
- Acronym / sponsor ID
- 2021-784-1
- Conditions
- Knowledge, Oral Health, Pregnant Women, Intervention
- Keywords
- oral health, knowledge, pregnant, improvement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 14 May 2026 (actual)
- Study completion
- 29 Jul 2026 (estimated)
- First posted
- 17 Feb 2026 (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 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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women Receiving an Informational Leaflet | Other | Other: Informational LeafletA 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women aged 18-45 who have recently given birth to healthy babies, either vaginally or by cesarean section.
- Ability to understand and speak Spanish.
Key exclusion criteria (3 listed)
- Complications during pregnancy or delivery.
- Newborns with major birth defects.
- Participants who do not provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Informational LeafletThe 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. | Other | Pregnant Women Receiving an Informational Leaflet |
Primary outcome
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.
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 30 Jul 2026.
- Derived from this study: PubMed 42930449Aznar-Marin A, Casana-Ruiz MD, Marcos-Puig B, Vello-Ribes MA, Perales-Marin A, Catala-Pizarro M. Knowledge of Oral Health in Pregnant and Puerperal Women: Effect of a Short Educational Intervention. Dent J (Basel). 2026 Oct 19;14(10):683. doi: 10.3390/dj14100683.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informational Leaflet in people with Knowledge and Oral Health, run by University of Valencia 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 30 Jul 2026. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07413393, which also lists 1 linked publication.
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 30 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.