Dental discoloration and quality of life after early prolonged high bilirubin in children
Official title: Prevalence of Dental Dyschromia and Impact on the Quality of Life of Participants With Prolonged Hyperbilirubinemia During Their Early Years
Run by University Hospital, Toulouse · NCT06506734 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 12 Years to 18 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 9 sites (Bordeaux and 8 other locations) |
| Status | Recruiting |
| Started | April 7, 2026 |
| Main results expected | October 7, 2027 |
| Study ends | October 7, 2027 |
| Registry record updated | May 12, 2026 |
| Trial ID | NCT06506734 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Show 3 more locations
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.