Dentinogenesis ImperfectaAiDiBullNCT04927962
Psycho-social Impact of Amelogenesis and Dentinogenesis Imperfecta
An observational study of Dentinogenesis Imperfecta and Amelogenesis Imperfecta, run by University Hospital, Toulouse at 7 sites in France.
Trial summary
The purpose of this research is to study the impact of dentinogenesis (DI) and amelogenesis (AI) imperfecta on oral quality of life, exposure to bullying and dental anxiety in a population of adolescents. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Dentinogenesis Imperfecta, Amelogenesis Imperfecta
- What is being tested?
- Questionnaires
- Type of treatment
- Pill or oral medicine
- How many people
- 87 participants
- Where
- 7 sitesFrance
- Study dates
- 22 Sep 2021to 3 Apr 2024
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients having a non-syndromic amelogenesis imperfecta or dentinogenesis imperfecta and consulting for a care or follow-up consultation.
Who may be able to join
- be between 10 and 18 years of age,
- consult for a care or follow-up consultation
- having a non-syndromic amelogenesis imperfecta or dentinogenesis imperfecta
- having access to a cell phone and/or tablet and/or personal or family computer
- covered by the social security of one of his parents
- understand French and one of whose parents (or legal representative) understands French
- have declared his or her non-opposition and one of whose parents (or legal representative) has declared his or her non-opposition to participate in the study.
Who cannot join
- Child presenting for diagnostic consultation and child who cannot read or whose 2 parents (legal representatives) cannot read
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHU de Bordeaux
Bordeaux, 33000
Hospices Civils de Lyon
Lyon, 69365
AP-HM
Marseille, 13385
CHU de Nantes
Nantes, 44000
AP-HP
Paris, 75012
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
University hospital of Toulouse
Toulouse, 31059
About this study
Official title: Psycho-social Impact of Amelogenesis and Dentinogenesis Imperfecta in Young People
The purpose of this research is to study the impact of dentinogenesis (DI) and amelogenesis (AI) imperfecta on oral quality of life, exposure to bullying and dental anxiety in a population of adolescents. WThe present study will use validated scales to evaluate the impact of bullying on the oral quality of live of youth aged 10 to 18 years, with non-syndromic DI or AI treated in seven national competence or reference centers in rare oral diseases.
- Conditions
- Dentinogenesis Imperfecta, Amelogenesis Imperfecta
- Being tested
- Questionnaires
- Keywords
- Amelogenesis imperfecta, Dentinogenesis imperfecta, Bullying, Oral health related quality of life, Dental anxiety
- Medical subject headings
- Dentinogenesis Imperfecta, Amelogenesis Imperfecta, Bullying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
For youth: self-reported questionnaires (on oral quality of life, bullying and cyberbullying, dental anxiety) and routine clinical examination for adolescents. For one parent: self-reported questionnaires (on perceived oral quality of life of their child and on their own dental anxiety).
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Oral Health Impact Profile (COHIP)
Difference between the average total COHIP questionnaire score of bullied and non bullied patients at D0 (no follow up is planned). A youth is considered bullied if he or she answers "three or more" at least once on the Bullying and Cyberbullying scale for Adolescent questionnaire)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start22 Sep 2021
- Primary completion3 Apr 2024
- Study completion3 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentinogenesis ImperfectaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric VAYSSE, Principal investigator, University hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927962
- Sponsor's protocol ID
- RC31/20/0255
- Acronym
- AiDiBull
- Status last verified
- Apr 2025
- First submitted
- 9 Jun 2021
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psycho-social Impact of Amelogenesis and Dentinogenesis Imperfecta in Young People
- ClinicalTrials.gov ID
- NCT04927962
- Acronym / sponsor ID
- AiDiBull / RC31/20/0255
- Conditions
- Dentinogenesis Imperfecta, Amelogenesis Imperfecta
- Keywords
- Amelogenesis imperfecta, Dentinogenesis imperfecta, Bullying, Oral health related quality of life, Dental anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 16 Jun 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 purpose of this research is to study the impact of dentinogenesis (DI) and amelogenesis (AI) imperfecta on oral quality of life, exposure to bullying and dental anxiety in a population of adolescents. WThe present study will use validated scales to evaluate the impact of bullying on the oral quality of live of youth aged 10 to 18 years, with non-syndromic DI or AI treated in seven national competence or reference centers in rare oral diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients having a non-syndromic amelogenesis imperfecta or dentinogenesis imperfecta and consulting for a care or follow-up consultation.
Key inclusion criteria (7 listed)
- be between 10 and 18 years of age,
- consult for a care or follow-up consultation
- having a non-syndromic amelogenesis imperfecta or dentinogenesis imperfecta
- having access to a cell phone and/or tablet and/or personal or family computer
- covered by the social security of one of his parents
Key exclusion criteria (1 listed)
- Child presenting for diagnostic consultation and child who cannot read or whose 2 parents (legal representatives) cannot read
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 |
|---|---|---|
| QuestionnairesFor youth: self-reported questionnaires (on oral quality of life, bullying and cyberbullying, dental anxiety) and routine clinical examination for adolescents. For one parent: self-reported questionnaires (on perceived oral quality of life of their child and on their own dental anxiety). | Other | – |
Primary outcome
Child Oral Health Impact Profile (COHIP)
Time frame: Baseline
Difference between the average total COHIP questionnaire score of bullied and non bullied patients at D0 (no follow up is planned). A youth is considered bullied if he or she answers "three or more" at least once on the Bullying and Cyberbullying scale for Adolescent questionnaire)
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 4 May 2025.
- Individual participant dataSharing planned: No
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.
Frédéric VAYSSE principal investigator
University hospital of Toulouse
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dentinogenesis Imperfecta and Amelogenesis Imperfecta, run by University Hospital, Toulouse at 7 sites 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 7 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 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Child Oral Health Impact Profile (COHIP) (time frame: Baseline). 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 4 May 2025.