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RecruitingNCT06506734SMILEUpdated May 12, 2026

Dental Dyschromia and Quality of Life in Early Prolonged Hyperbilirubinemia

An observational study in Dental Diseases, sponsored by University Hospital, Toulouse. Recruiting at 9 sites in France. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by University Hospital, Toulouse · Observational

From the registry’s dates

  • Started Apr 2026; still recruiting 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
120
Ages
12 Years to 18 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Dental Diseases

Keywords

  • Hyperbilirubinemia
  • Biliary Atresia
  • Progressive Familial Intrahepatic Cholestasis (PFIC)
  • Alagille Syndrome
  • Tooth Discoloration
03

In context

Stomatognathic Diseases

80 studies on the registry are indexed under Stomatognathic Diseases; 14 are open to participants now.

This study's planned enrollment of 120 is close to the median of 128 across 19 observational studies indexed under Stomatognathic Diseases.

Browse Stomatognathic Diseases studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children aged 12 to 18 years

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Inability to understand and respond to quality of life questionnaires
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • Dental Dyschromia in Hyperbilirubinemia Patients

    30 minutes

    Other: Questionnaires

Interventions

  • OtherQuestionnaires

    * " 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.

    Also known as: Photograph

06

What researchers measure

Primary outcomes

  1. Prevalence of dental dyschromia

    presence of dyschromia or not evaluated by 2 investigators

    Time frame: from birth to study completion, a maximum of 19 years

Secondary outcomes

  1. Presence or absence of dental dyschromia

    Presence or absence of dental dyschromia based on various variables such as bilirubin levels or the duration of hyperbilirubinemia.

    Time frame: through study completion, an average of 18 months

Other outcomes

  1. Quality of life score by patient group

    Assess the quality of life score based on the patient's group classification

    Time frame: through study completion, an average of 18 months

07

Study locations

9 of 9 sites recruiting
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06506734
Responsible party
Sponsor
First posted
Jul 17, 2024
Start date
Apr 7, 2026
Primary completion
Oct 7, 2027 (estimated)
Completion
Oct 7, 2027 (estimated)
Last update
May 12, 2026

Study contacts

Nolwenn LABORDE, MD
Contact
laborde.n@chu-toulouse.fr
05 61 77 96 70
Romain LOPEZ, PharmD
Contact
lopez.ro@chu-toulouse.fr
Nolwen LABORDE, MD
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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