Carious DiseaseNCT04123184
Oral Health Perception and Difficulties Encountered by Parents in the Implementation of Oral Hygiene of Children Under 6
An observational study of Carious Disease, run by University Hospital, Montpellier at 1 site in France.
Trial summary
A qualitative analysis was carried out on 15 participants, in 3 different places: the Montpellier health center, a pediatric odontology practice in Nîmes and a dentistry practice in Marseille. Two methods of analysis were chosen: thematic analysis and word counting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carious Disease
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2019to 1 Jun 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parents or caregiver of the child, men or women, aged at least 18 years old, with a good understanding of the French language, accepting the terms of the study and not opposing its realization. The parent or caregiver with at least one child under the age of 6 who has a carious lesion or not.
Who may be able to join
- Parent or caregiver with at least one child under 6 years of age, with Caod ≥ 1 and high RCI
Who cannot join
- Patient refusing to participate in the study.
- Patient who does not understand the French language or who has difficulty expressing himself.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Health Perception and Difficulties Encountered by Parents in the Implementation of Oral Hygiene of Children Under 6, Qualitative Study.-
A qualitative analysis was carried out on 15 participants, in 3 different places: the Montpellier health center, a pediatric odontology practice in Nîmes and a dentistry practice in Marseille.
Two methods of analysis were chosen: thematic analysis and word counting.
- Conditions
- Carious Disease
- Keywords
- Therapeutic patient education, Having one child who as less than 6 years old, Pediatric Dentistry, Oral Health, Chronic Disease
- Medical subject headings
- Chronic Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the image that parents have of oral health and carious disease
Evaluation of the image that parents of oral health and carious disease by individual semi-guided interview
Measured: 1 day
Secondary outcomes (1)
Evaluation of the motivations and brakes encountered by parents in the implementation of oral hygiene of their child
Evaluation of the motivations and brakes encountered by parents in the implementation of oral hygiene of their child with early childhood caries (CPE) by individual semi-guided interview
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 posted10 Oct 2019
- Study start1 Apr 2019
- Primary completion30 Apr 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carious DiseaseStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Taormina Marion, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123184
- Sponsor's protocol ID
- RECHMPL18_0417
- Status last verified
- Oct 2019
- First submitted
- 9 Oct 2019
- Last updated
- 10 Oct 2019
- 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 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Perception and Difficulties Encountered by Parents in the Implementation of Oral Hygiene of Children Under 6, Qualitative Study.-
- ClinicalTrials.gov ID
- NCT04123184
- Acronym / sponsor ID
- RECHMPL18_0417
- Conditions
- Carious Disease
- Keywords
- Therapeutic patient education, Having one child who as less than 6 years old, Pediatric Dentistry, Oral Health, Chronic Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 10 Oct 2019 (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.
A qualitative analysis was carried out on 15 participants, in 3 different places: the Montpellier health center, a pediatric odontology practice in Nîmes and a dentistry practice in Marseille.
Two methods of analysis were chosen: thematic analysis and word counting.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parents or caregiver of the child, men or women, aged at least 18 years old, with a good understanding of the French language, accepting the terms of the study and not opposing its realization. The parent or caregiver with at least one child under the age of 6 who has a carious lesion or not.
Key inclusion criteria (1 listed)
- Parent or caregiver with at least one child under 6 years of age, with Caod ≥ 1 and high RCI
Key exclusion criteria (2 listed)
- Patient refusing to participate in the study.
- Patient who does not understand the French language or who has difficulty expressing himself.
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
Evaluation of the image that parents have of oral health and carious disease
Time frame: 1 day
Evaluation of the image that parents of oral health and carious disease by individual semi-guided interview
1 secondary outcome
Evaluation of the motivations and brakes encountered by parents in the implementation of oral hygiene of their child
Time frame: 1 day
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 10 Oct 2019.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Carious Disease
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Total Pulpotomy With Two Repair Cements in Hypomineralized Teeth
Molar-Incisor Hypomineralization (MIH)
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Outcome of Selective Caries Removal Performed by Undergraduate Students
Deep Caries Lesion of Pemanent Teeth
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Laser Assisted Pulpotomy Versus MTA Pulpotomy in Permanent Teeth With Irreversible Pulpitis
Irreversible Pulpitis (Toothache)
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.
Taormina Marion, MD principal investigator
University Hospital, 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 Carious Disease, 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 1 inclusion and 2 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 10 Oct 2019. 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?
Evaluation of the image that parents have of oral health and carious disease (time frame: 1 day). 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 10 Oct 2019.