Dental Dyschromia and Quality of Life in Early Prolonged Hyperbilirubinemia

Not yet recruiting

• Conditions: Dental Diseases
• Interventions: Other: Questionnaires

• Registration Number: NCT06506734
• Lead Sponsor: University Hospital, Toulouse

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-07-16
• Study First Posted: 2024-07-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08
• Study Start: 2025-12-01
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dental Dyschromia in Hyperbilirubinemia Patients	Questionnaires	30 minutes

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (9)

University Hospital Bordeaux; 🇫🇷 Bordeaux, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France

Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre, FHU Hépatinov; 🇫🇷 Paris, France

University Hospital Lille; 🇫🇷 Lille, France

University Hospital Marseille; 🇫🇷 Marseille, France

Assistance Publique-Hôpitaux de Paris, Hôpital Necker; 🇫🇷 Paris, France

Assistance Publique-Hôpitaux de Paris, Hôpital Bretonneau, Paris; 🇫🇷 Paris, France

University Hospital Rennes; 🇫🇷 Rennes, France

University Hosptial Caen; 🇫🇷 Caen, France