Dental CariesOHAPNCT04992754
Oral Health and Pregnancy
An observational study of Dental Caries and Pregnancy Related, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The aim of this study is to identify the knowledge, behavior and social representation on dental health among pregnant women. This study could improve, in the future, prevention, treatments and care for them. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Dental Caries, Pregnancy Related
- What is being tested?
- psychotherapy, lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jul 2021to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: pregnant women over 18 years old in the Montpellier's hospital
Who may be able to join
- pregnant t women over 18 years old
- French language
Who cannot join
- pregnant women under 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Health and Pregnancy : Relation Between Knowledge, Practices and Social Representation of Pregnant Women in the Gynecologie Department at the Montpellier's CHRU
The aim of this study is to identify the knowledge, behavior and social representation on dental health among pregnant women. This study could improve, in the future, prevention, treatments and care for them.
Read the detailed description
Pregnant women will have to complete a questionnaire that brings together their knowledge, practices and social representations of oral health during their current pregnancy.
- Conditions
- Dental Caries, Pregnancy Related
- Being tested
- psychotherapy, lifestyle counseling
- Keywords
- Oral hygiene, Public Health, Pregnancy, Prevention, Patients coming to the CHU ADV Montpellier for consultation, Pregnant patients, Knowledge, Literacy
- Medical subject headings
- Dental Caries, Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychotherapy, lifestyle counselingBehavioural
psychotherapy, lifestyle counseling
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women over 18 years old coming to consult at the gynecology department | Pregnant women over 18 years old coming to consult at the gynecology department in the Montpellier's hospital Receives: Behavioral: psychotherapy, lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the knowledge
Evaluate the knowledge on the oral health among pregnant woman
Measured: 1 day
Evaluate the practices
Evaluate the practices on the oral health among pregnant woman
Measured: 1 day
Secondary outcomes (1)
Evaluate the social representation
Evaluate the social representation on the oral health among pregnant woman
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start20 Jul 2021
- Primary completion30 Oct 2021
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camille INQUIMBERT, PhD, Study director, University Hospital, MontpellierCamille AMMOR, GRANDATI, resident, Principal investigator, UH MONTPELLIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992754
- Sponsor's protocol ID
- RECHMPL21_0484
- Acronym
- OHAP
- Status last verified
- Jul 2021
- First submitted
- 28 Jul 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health and Pregnancy : Relation Between Knowledge, Practices and Social Representation of Pregnant Women in the Gynecologie Department at the Montpellier's CHRU
- ClinicalTrials.gov ID
- NCT04992754
- Acronym / sponsor ID
- OHAP / RECHMPL21_0484
- Conditions
- Dental Caries, Pregnancy Related
- Keywords
- Oral hygiene, Public Health, Pregnancy, Prevention, Patients coming to the CHU ADV Montpellier for consultation, Pregnant patients, Knowledge, Literacy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 5 Aug 2021 (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 aim of this study is to identify the knowledge, behavior and social representation on dental health among pregnant women. This study could improve, in the future, prevention, treatments and care for them.
Detailed description
Pregnant women will have to complete a questionnaire that brings together their knowledge, practices and social representations of oral health during their current pregnancy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women over 18 years old coming to consult at the gynecology department | – | Behavioral: psychotherapy, lifestyle counselingPregnant women over 18 years old coming to consult at the gynecology department in the Montpellier's hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pregnant women over 18 years old in the Montpellier's hospital
Key inclusion criteria (2 listed)
- pregnant t women over 18 years old
- French language
Key exclusion criteria (1 listed)
- pregnant women under 18 years old
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 |
|---|---|---|
| psychotherapy, lifestyle counselingpsychotherapy, lifestyle counseling | Behavioural | Pregnant women over 18 years old coming to consult at the gynecology department |
Primary outcome
Evaluate the knowledge
Time frame: 1 day
Evaluate the knowledge on the oral health among pregnant woman
Evaluate the practices
Time frame: 1 day
Evaluate the practices on the oral health among pregnant woman
1 secondary outcome
Evaluate the social representation
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Individual participant dataSharing planned: Undecided. NC
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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. This study is not recruiting at the moment.
Camille INQUIMBERT, PhD study director
University Hospital, Montpellier
Camille AMMOR, GRANDATI, resident principal investigator
UH MONTPELLIER
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 Dental Caries and Pregnancy Related, run by University Hospital, Montpellier at 1 site in France.
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 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: status not confirmed, as of the sponsor's last update on 1 Feb 2022. 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 France. 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?
Results are not available in the source record.
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?
Evaluate the knowledge (time frame: 1 day). The study lists 2 primary outcomes in all. 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 1 Feb 2022.