Dental Dyschromia and Quality of Life in Early Prolonged Hyperbilirubinemia

Prevalence of Dental Dyschromia and Impact on the Quality of Life of Participants With Prolonged Hyperbilirubinemia During Their Early Years

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06506734

Acronym

SMILE

Enrollment

120

Registered

2024-07-17

Start date

2026-04-07

Completion date

2027-10-07

Last updated

2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Diseases

Keywords

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

Brief 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.

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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Prevalence of dental dyschromia	from birth to study completion, a maximum of 19 years	presence of dyschromia or not evaluated by 2 investigators

Secondary

Measure	Time frame	Description
Presence or absence of dental dyschromia	through study completion, an average of 18 months	Presence or absence of dental dyschromia based on various variables such as bilirubin levels or the duration of hyperbilirubinemia.

Countries

France

Contacts

CONTACTNolwenn LABORDE, MD

laborde.n@chu-toulouse.fr05 61 77 96 70

CONTACTRomain LOPEZ, PharmD

lopez.ro@chu-toulouse.fr

PRINCIPAL_INVESTIGATORNolwen LABORDE, MD

University Hospital, Toulouse

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026