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

May 7, 2026 updated by: University Hospital, Toulouse

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

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: from birth to study completion, a maximum of 19 years
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
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.
through study completion, an average of 18 months

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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