Dental Dyschromia and Quality of Life in Early Prolonged Hyperbilirubinemia

NCT06506734 | Not Yet Recruiting

• 1 other identifier: RC31/23/0443
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 9

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.

Conditions

Dental Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Prevalence of dental dyschromia

  presence of dyschromia or not evaluated by 2 investigators

  from birth to study completion, a maximum of 19 years

Secondary Outcomes (1)

• Presence or absence of dental dyschromia

  through study completion, an average of 18 months

Other Outcomes (1)

• Quality of life score by patient group

  through study completion, an average of 18 months

Study Arms (1)

Dental Dyschromia in Hyperbilirubinemia Patients

30 minutes

Other: Questionnaires

Interventions

Questionnaires OTHER

* " 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

Dental Dyschromia in Hyperbilirubinemia Patients

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 12 to 18 years

You may qualify if:

• A patient with biliary atresia, progressive familial intrahepatic cholestasis, or Alagille syndrome
• Patient or legal representative not opposed to participating in this research.

You may not qualify if:

• Inability to understand and respond to quality of life questionnaires

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (9)

University Hospital Bordeaux

Bordeaux, France

Location

University Hosptial Caen

Caen, France

Location

University Hospital Lille

Lille, France

Location

Hospices Civils de Lyon

Lyon, France

Location

University Hospital Marseille

Marseille, France

Location

Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre, FHU Hépatinov

Paris, France

Location

Assistance Publique-Hôpitaux de Paris, Hôpital Bretonneau, Paris

Paris, France

Location

Assistance Publique-Hôpitaux de Paris, Hôpital Necker

Paris, France

Location

University Hospital Rennes

Rennes, France

Location

MeSH Terms

Conditions

Stomatognathic Diseases; Hyperbilirubinemia; Biliary Atresia; Cholestasis, progressive familial intrahepatic 1; Alagille Syndrome; Tooth Discoloration

Interventions

Surveys and Questionnaires; Moire Topography

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cholestasis, Intrahepatic; Cholestasis; Liver Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Abnormalities, Multiple; Genetic Diseases, Inborn; Tooth Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Photogrammetry; Photography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Interferometry

Study Officials

• Nolwen LABORDE, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nolwenn LABORDE, MD

CONTACT

05 61 77 96 70; laborde.n@chu-toulouse.fr

Romain LOPEZ, PharmD

CONTACT

lopez.ro@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 17, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 2, 2026
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

FR (9)