Dental CareBUCCOMATERNCT04269759
145/5000 Oral State and Knowledge, Attitudes and Practices of Pregnant Women on Their Oral Health and That of Their Unborn Child
An observational study of Dental Care, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Pregnancy is a physiological condition which is accompanied by changes in the oral sphere which may increase the need for oral care and prevention. The role of dental surgeons is to provide appropriate care and to provide information on the prevention of oral diseases of pregnant women but also of their unborn baby. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dental Care
- What is being tested?
- Survey and dental care
- Type of treatment
- Pill or oral medicine
- How many people
- 117 participants
- Where
- 1 siteFrance
- Study dates
- 13 May 2019to 9 Sep 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women
Who may be able to join
- Pregnant women
Who cannot join
- Patient refuses to participate in the study.
- Persons under guardianship
- No understanding of oral French.
- People with decompensated severe psychiatric disorder or severe cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral State and Knowledge, Attitudes and Practices of Pregnant Women on Their Oral Health and That of Their Unborn Child
Pregnancy is a physiological condition which is accompanied by changes in the oral sphere which may increase the need for oral care and prevention. The role of dental surgeons is to provide appropriate care and to provide information on the prevention of oral diseases of pregnant women but also of their unborn baby.
Investigators wants to determine if pregnants women know that national health insurance has set up a free dental care preventive examination.
Read the detailed description
Investigators will describe the knowledge, attitudes and practices of pregnant women consulting at the maternity of Bordeaux University Hospital with regard to the oral examination of health insurance.
This study will also Evaluate the care needs and the acceptability of oral screening and study the association between the use of prenatal health insurance and dental health.
- Conditions
- Dental Care
- Being tested
- Survey, dental care
- Keywords
- prevention, dental care, pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
pregnant women will answer to a survey regarding their oral health knowledge, attitudes and practices for themselves and their unborn child
dental careOther
pregnant women will have a dental care
| Study group | Role | What they receive |
|---|---|---|
| Pregnancy women | Not described Receives: Other: Survey; Other: dental care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of prenatal health insurance for free dental examination
The use of this dental examination will be assessed with a survey
Measured: Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start13 May 2019
- Primary completion9 Sep 2019
- Study completion9 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CareStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269759
- Sponsor's protocol ID
- CHUBX 2019/14
- Acronym
- BUCCOMATER
- Status last verified
- Mar 2023
- First submitted
- 7 Feb 2020
- Last updated
- 16 Mar 2023
- 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 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral State and Knowledge, Attitudes and Practices of Pregnant Women on Their Oral Health and That of Their Unborn Child
- ClinicalTrials.gov ID
- NCT04269759
- Acronym / sponsor ID
- BUCCOMATER / CHUBX 2019/14
- Conditions
- Dental Care
- Keywords
- prevention, dental care, pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 13 May 2019 (actual)
- Primary completion
- 9 Sep 2019 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 17 Feb 2020 (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.
Pregnancy is a physiological condition which is accompanied by changes in the oral sphere which may increase the need for oral care and prevention. The role of dental surgeons is to provide appropriate care and to provide information on the prevention of oral diseases of pregnant women but also of their unborn baby.
Investigators wants to determine if pregnants women know that national health insurance has set up a free dental care preventive examination.
Detailed description
Investigators will describe the knowledge, attitudes and practices of pregnant women consulting at the maternity of Bordeaux University Hospital with regard to the oral examination of health insurance.
This study will also Evaluate the care needs and the acceptability of oral screening and study the association between the use of prenatal health insurance and dental health.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnancy women | – | Other: Survey, Other: dental care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women
Key inclusion criteria (1 listed)
- Pregnant women
Key exclusion criteria (4 listed)
- Patient refuses to participate in the study.
- Persons under guardianship
- No understanding of oral French.
- People with decompensated severe psychiatric disorder or severe cognitive impairment.
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 |
|---|---|---|
| Surveypregnant women will answer to a survey regarding their oral health knowledge, attitudes and practices for themselves and their unborn child | Other | Pregnancy women |
| dental carepregnant women will have a dental care | Other | Pregnancy women |
Primary outcome
Use of prenatal health insurance for free dental examination
Time frame: Enrollment
The use of this dental examination will be assessed with a survey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
Related trials for Dental Care
Not yet recruiting
Is Routine Dental Clearance or Antibiotic Prophylaxis Before Dental Procedures Necessary in Total Joint Arthroplasty?
Elective Primary THA or TKA
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
Active, not recruiting
Musical Intervention for Dental Anxiety
Dental Anxiety
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Recruiting
Home-Use Dual-Light Antibacterial Photodynamic Therapy for Peri-Implant Mucositis in Full-Arch Implant Prostheses
Peri Implant Mucositis, Dental Implant Rehabilitation
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.
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 Dental Care, run by University Hospital, Bordeaux 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 16 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Use of prenatal health insurance for free dental examination (time frame: Enrollment). 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 16 Mar 2023.