Dental Dyschromia and Quality of Life in Early Prolonged Hyperbilirubinemia (SMILE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Diseases
• Intervention / Treatment: Other: Questionnaires

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Nolwenn LABORDE, MD; Phone Number: 05 61 77 96 70; Email: laborde.n@chu-toulouse.fr
• Study Contact Backup: Name: Romain LOPEZ, PharmD; Email: lopez.ro@chu-toulouse.fr

Study Locations

• France
  • Bordeaux, France
    • Recruiting
    • University Hospital Bordeaux
  • Caen, France
    • Recruiting
    • University Hosptial Caen
  • Lille, France
    • Recruiting
    • University Hospital Lille
  • Lyon, France
    • Recruiting
    • Hospices Civils de Lyon
  • Marseille, France
    • Recruiting
    • University Hospital Marseille
  • Paris, 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
  • Rennes, France
    • Recruiting
    • University Hospital Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children aged 12 to 18 years

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dental Dyschromia in Hyperbilirubinemia Patients; 30 minutes	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.; Other Names: Photograph

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	through study completion, an average of 18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life score by patient group	Assess the quality of life score based on the patient's group classification	through study completion, an average of 18 months

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Nolwen LABORDE, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2026
• Primary Completion (Estimated): October 7, 2027
• Study Completion (Estimated): October 7, 2027

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Hyperbilirubinemia; Biliary Atresia; Tooth Discoloration; Alagille Syndrome; Progressive Familial Intrahepatic Cholestasis (PFIC)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Genetic Diseases, Inborn; Tooth Diseases; Digestive System Diseases; Biliary Tract Diseases; Liver Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Abnormalities, Multiple; Bile Duct Diseases; Cholestasis, Intrahepatic; Cholestasis; Digestive System Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Tooth Discoloration; Biliary Atresia; Alagille Syndrome; Stomatognathic Diseases; Hyperbilirubinemia; Cholestasis, progressive familial intrahepatic 1; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Diagnostic Techniques and Procedures; Diagnosis; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Diagnostic Imaging; Photography; Interferometry; Photogrammetry; Surveys and Questionnaires; Moire Topography
• Other Study ID Numbers: RC31/23/0443

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No