Dental discoloration and quality of life after early prolonged high bilirubin in children
Prevalence of Dental Dyschromia and Impact on the Quality of Life of Participants With Prolonged Hyperbilirubinemia During Their Early Years
We will see if children with biliary atresia, PFIC, or Alagille syndrome who had prolonged high bilirubin as infants have more tooth discoloration and worse quality of life than those without discoloration.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 9 sites (Bordeaux and 8 other locations) |
| Trial ID | NCT06506734 on ClinicalTrials.gov |
What this trial studies
This observational study will measure how common dental dyschromia is among children who experienced prolonged hyperbilirubinemia early in life and will collect information on bilirubin severity, duration, underlying liver disease, and treatments received. Participants or their legal representatives will complete questionnaires about dental appearance and quality of life, and dental examinations may be recorded when available. Data analysis will look for links between bilirubin exposure, specific diagnoses (biliary atresia, PFIC, Alagille syndrome), treatments, and the presence of tooth discoloration and its impact on quality of life. Findings will be used to inform clinical recommendations and discussions with insurers about coverage for dental care for affected children.
Who should consider this trial
Good fit: Children with biliary atresia, progressive familial intrahepatic cholestasis (PFIC), or Alagille syndrome who experienced early prolonged hyperbilirubinemia and whose guardian can complete quality-of-life questionnaires are ideal candidates.
Not a fit: Patients who cannot understand or complete the questionnaires or whose tooth discoloration has a clear non-bilirubin cause are unlikely to benefit from the study findings.
Why it matters
Potential benefit: If successful, this work could support coverage for dental care and targeted prevention or treatment for children who develop bilirubin-related tooth discoloration.
How similar studies have performed: Case reports and small series have linked neonatal hyperbilirubinemia to tooth discoloration, but few studies have quantified prevalence or measured quality-of-life impact, so the approach is only partially established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bordeaux and 8 other locations
- University Hospital Bordeaux — Bordeaux, France (Recruiting)
- University Hosptial Caen — Caen, France (Recruiting)
- University Hospital Lille — Lille, France (Recruiting)
- Hospices Civils de Lyon — Lyon, France (Recruiting)
- University Hospital Marseille — Marseille, France (Recruiting)
- Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre, FHU Hépatinov — Paris, France (Recruiting)
- Assistance Publique-Hôpitaux de Paris, Hôpital Bretonneau, Paris — Paris, France (Recruiting)
- Assistance Publique-Hôpitaux de Paris, Hôpital Necker — Paris, France (Recruiting)
- University Hospital Rennes — Rennes, France (Recruiting)
Study contacts
- Principal investigator: Nolwen LABORDE, MD — University Hospital, Toulouse
- Study coordinator: Nolwenn LABORDE, MD
- Email: laborde.n@chu-toulouse.fr
- Phone: 05 61 77 96 70
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.