Dental DiseasesSMILENCT06506734
Dental Dyschromia and Quality of Life in Early Prolonged Hyperbilirubinemia
An observational study of Dental Diseases, run by University Hospital, Toulouse at 9 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Dental Diseases
- What is being tested?
- Questionnaires
- How many people
- 120 participants
- Where
- 9 sitesFrance
- Study dates
- 7 Apr 2026to 7 Oct 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children aged 12 to 18 years
Who may be able to join
- A patient with biliary atresia, progressive familial intrahepatic cholestasis, or Alagille syndrome
- Patient or legal representative not opposed to participating in this research.
Who cannot join
- Inability to understand and respond to quality of life questionnaires
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Romain LOPEZ, PharmD contact
9 sites in 1 country
France9 sites, 9 recruiting
- Recruiting
University Hospital Bordeaux
Bordeaux
- Recruiting
University Hosptial Caen
Caen
- Recruiting
University Hospital Lille
Lille
- Recruiting
Hospices Civils de Lyon
Lyon
- Recruiting
University Hospital Marseille
Marseille
- Recruiting
Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre, FHU Hépatinov
Paris
- Recruiting
Assistance Publique-Hôpitaux de Paris, Hôpital Bretonneau, Paris
Paris
- Recruiting
Assistance Publique-Hôpitaux de Paris, Hôpital Necker
Paris
- Recruiting
University Hospital Rennes
Rennes
About this study
Official title: 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.
- Conditions
- Dental Diseases
- Being tested
- Questionnaires
- Keywords
- Hyperbilirubinemia, Biliary Atresia, Progressive Familial Intrahepatic Cholestasis (PFIC), Alagille Syndrome, Tooth Discoloration
- Medical subject headings
- Stomatognathic Diseases, Hyperbilirubinemia, Biliary Atresia, Cholestasis, progressive familial intrahepatic 1, Alagille Syndrome, Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Also called Photograph
- " 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.
| Study group | Role | What they receive |
|---|---|---|
| Dental Dyschromia in Hyperbilirubinemia Patients | 30 minutes Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of dental dyschromia
presence of dyschromia or not evaluated by 2 investigators
Measured: from birth to study completion, a maximum of 19 years
Secondary outcomes (1)
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.
Measured: through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start7 Apr 2026
- Primary completion7 Oct 2027 (estimated)
- Study completion7 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nolwen LABORDE, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506734
- Sponsor's protocol ID
- RC31/23/0443
- Acronym
- SMILE
- Status last verified
- May 2026
- First submitted
- 28 Jun 2024
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No