SchoolboyOHACNCT03791632
Oral Health Among Children
A study testing classical lecture style presentation, an intervention in the form of fun workshops and digital media intervention in people with Schoolboy, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The aim of this study is to identify the knowledge and behavior on dental health and hygiene among adolescents. In most cases, the investigators know tooth decay can be prevented and reversed at an early stage by observing good oral hygiene. Few studies have been done among adolescents. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Schoolboy
- What is being tested?
- classical lecture style presentation, an intervention in the form of fun workshops and digital media intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2018to 30 Dec 2019
- Phase
- Interventional
- 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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All children of classrooms selectionned
Who cannot join
- Children absent on the day of the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Health Knowledge and Practice Among 8-9 Years Old Children.
The aim of this study is to identify the knowledge and behavior on dental health and hygiene among adolescents. In most cases, the investigators know tooth decay can be prevented and reversed at an early stage by observing good oral hygiene. Few studies have been done among adolescents.
This study could justify the implementation of public health actions in terms of prevention.
- Conditions
- Schoolboy
- Being tested
- classical lecture style presentation, an intervention in the form of fun workshops, digital media intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
classical lecture style presentationOther
classical lecture style presentation
an intervention in the form of fun workshopsOther
an intervention in the form of fun workshops on different themes by small groups of schoolchildren (8-10 children per workshop)
digital media interventionOther
digital media intervention
| Study group | Role | What they receive |
|---|---|---|
| witness | No intervention | 2 control CE2 classes without oral sensitization actions |
| group intervention 1 | Experimental | 2 CE2 classes with a classical lecture style presentation Receives: Other: classical lecture style presentation |
| group intervention 2 | Experimental | 2 CE2 classes with an intervention in the form of fun workshops on different themes by small groups of schoolchildren (8-10 children per workshop) Receives: Other: an intervention in the form of fun workshops |
| group intervention 3 | Experimental | 2 CE2 classes with digital media intervention Receives: Other: digital media intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of children's notes before and after a prevention intervention
The main result will be calculated with the total score to the questions. Each question corresponds to a point. The minimum score is 0 and the maximum score is 25.
We will compare the evolution of the averages obtained by the control group and by all three other groups with Student test
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 posted2 Jan 2019
- Study start1 Dec 2018
- Primary completion1 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchoolboyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Test group 2. Classes with a classical lecture style presentation 3. classes with an intervention in the form of fun workshops on different themes by small groups of schoolchildren (8-10 children per workshop) 4. classes with digital media intervention
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camille INQUIMBERT, PhD student, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791632
- Sponsor's protocol ID
- RECHMPL18_0386
- Acronym
- OHAC
- Status last verified
- Mar 2020
- First submitted
- 18 Dec 2018
- Last updated
- 10 Mar 2020
- 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 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Knowledge and Practice Among 8-9 Years Old Children.
- ClinicalTrials.gov ID
- NCT03791632
- Acronym / sponsor ID
- OHAC / RECHMPL18_0386
- Conditions
- Schoolboy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 2 Jan 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.
The aim of this study is to identify the knowledge and behavior on dental health and hygiene among adolescents. In most cases, the investigators know tooth decay can be prevented and reversed at an early stage by observing good oral hygiene. Few studies have been done among adolescents.
This study could justify the implementation of public health actions in terms of prevention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 1. Test group 2. Classes with a classical lecture style presentation 3. classes with an intervention in the form of fun workshops on different themes by small groups of schoolchildren (8-10 children per workshop) 4. classes with digital media intervention
| Arm | Type | Receives |
|---|---|---|
| witness | No intervention | –2 control CE2 classes without oral sensitization actions |
| group intervention 1 | Experimental | Other: classical lecture style presentation2 CE2 classes with a classical lecture style presentation |
| group intervention 2 | Experimental | Other: an intervention in the form of fun workshops2 CE2 classes with an intervention in the form of fun workshops on different themes by small groups of schoolchildren (8-10 children per workshop) |
| group intervention 3 | Experimental | Other: digital media intervention2 CE2 classes with digital media intervention |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children of classrooms selectionned
Key exclusion criteria (1 listed)
- Children absent on the day of the intervention
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 |
|---|---|---|
| classical lecture style presentationclassical lecture style presentation | Other | group intervention 1 |
| an intervention in the form of fun workshopsan intervention in the form of fun workshops on different themes by small groups of schoolchildren (8-10 children per workshop) | Other | group intervention 2 |
| digital media interventiondigital media intervention | Other | group intervention 3 |
Primary outcome
comparison of children's notes before and after a prevention intervention
Time frame: 1 day
The main result will be calculated with the total score to the questions. Each question corresponds to a point. The minimum score is 0 and the maximum score is 25. We will compare the evolution of the averages obtained by the control group and by all three other groups with Student test
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 Mar 2020.
- Individual participant dataSharing planned: Undecided. NC
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 student 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?
A study testing classical lecture style presentation, an intervention in the form of fun workshops and digital media intervention in people with Schoolboy, 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 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: finished, as of the sponsor's last update on 10 Mar 2020. 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?
comparison of children's notes before and after a prevention intervention (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 Mar 2020.