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NCT Number: NCT06506734

Dental Dyschromia and Quality of Life in Early Prolonged Hyperbilirubinemia

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.

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Key information

Conditions

Dental Diseases Abnormalities, Multiple Alagille Syndrome Bile Duct Diseases Biliary Atresia Biliary Tract Diseases Cardiovascular Abnormalities Cardiovascular Diseases Cholestasis Cholestasis, Intrahepatic Cholestasis, progressive familial intrahepatic 1 Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Genetic Diseases, Inborn Heart Defects, Congenital Hyperbilirubinemia Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stomatognathic Diseases Tooth Discoloration Tooth Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Bordeaux, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Photograph

Primary outcomes

  1. Prevalence of dental dyschromia

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

    presence of dyschromia or not evaluated by 2 investigators

Secondary outcomes

  1. Presence or absence of dental dyschromia

    Time frame: 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.

Other outcomes

  1. Quality of life score by patient group

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Nolwenn LABORDE, MD

CONTACT

[email protected]

05 61 77 96 70

Romain LOPEZ, PharmD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: SMILE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 17, 2024
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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