CompletedNot Applicable

Psycho-social Impact of Amelogenesis and Dentinogenesis Imperfecta

France87 participantsStarted 2021-09-22

Plain-language 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. 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.

Who can participate

Age range

10 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * Child presenting for diagnostic consultation and child who cannot read or whose 2 parents (legal representatives) cannot read

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Child Oral Health Impact Profile (COHIP)

Timeframe: Baseline

Trial details

NCT IDNCT04927962

SponsorUniversity Hospital, Toulouse

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-04-03

View on ClinicalTrials.gov More Dentinogenesis Imperfecta trials