Dental Dyschromia and Quality of Life in Early Prolonged Hyperbilirubinemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Questionnaires.
- Who it may be relevant to
- Registry conditions: Dental Diseases. Basic parameters: 12 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prevalence of Dental Dyschromia and Impact on the Quality of Life of Participants With Prolonged Hyperbilirubinemia During Their Early Years
Overview
The main objective of this study is to assess the prevalence of dental discoloration (dental dyschromia) in children who experienced high levels of bilirubin in their blood (hyperbilirubinemia) during their early years. The study will also examine risk factors associated with this condition, such as the duration and severity of hyperbilirubinemia, underlying diseases, and treatments received. The researchers hypothesize that the quality of life of individuals with dental dyschromia is lower than that of individuals without dyschromia. The results of this study will be used to discuss coverage for dental care with health insurance for children affected by this condition.
Interventions
- Other Questionnaires
* " Psychosocial Impact of Dental Aesthetics Questionnaire " PMID 24280547 * " Orofacial Esthetic Scale " PMID 30856637 * " Orofacial Esthetic Scale " PMID 34231057 * A photograph of the patient's smile will be sent to 2 dentists who will also assess the presence or absence of dental dyschromia.
Primary outcome measures
- Prevalence of dental dyschromia [Time frame: from birth to study completion, a maximum of 19 years]
Secondary outcome measures (1)
- Presence or absence of dental dyschromia [Time frame: through study completion, an average of 18 months]
Eligibility criteria
Inclusion criteria
- A patient with biliary atresia, progressive familial intrahepatic cholestasis, or Alagille syndrome
- Patient or legal representative not opposed to participating in this research.
Exclusion criteria
- Inability to understand and respond to quality of life questionnaires
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 9 centers
- University Hospital Bordeaux — Bordeaux
- University Hosptial Caen — Caen
- University Hospital Lille — Lille
- Hospices Civils de Lyon — Lyon
- University Hospital Marseille — Marseille
- Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre, FHU Hépatinov — Paris
- Assistance Publique-Hôpitaux de Paris, Hôpital Bretonneau, Paris — Paris
- Assistance Publique-Hôpitaux de Paris, Hôpital Necker — Paris
- … and 1 more center
Identifiers
NCT: NCT06506734 · RC31/23/0443