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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Dental Dyschromia and Impact on the Quality of Life of Participants With Prolonged Hyperbilirubinemia During Their Early Years
- ClinicalTrials.gov ID
- NCT06506734
- Acronym / sponsor ID
- SMILE / RC31/23/0443
- Conditions
- Dental Diseases
- Keywords
- Hyperbilirubinemia, Biliary Atresia, Progressive Familial Intrahepatic Cholestasis (PFIC), Alagille Syndrome, Tooth Discoloration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- 7 Oct 2027 (estimated)
- Study completion
- 7 Oct 2027 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dental Dyschromia in Hyperbilirubinemia Patients | – | Other: Questionnaires30 minutes |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children aged 12 to 18 years
Key inclusion criteria (2 listed)
- A patient with biliary atresia, progressive familial intrahepatic cholestasis, or Alagille syndrome
- Patient or legal representative not opposed to participating in this research.
Key exclusion criteria (1 listed)
- Inability to understand and respond to quality of life questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesAlso: 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. | Other | Dental Dyschromia in Hyperbilirubinemia Patients |
Primary outcome
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
1 secondary outcome
Presence or absence of dental dyschromia
Time frame: through study completion, an average of 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Romain LOPEZ, PharmD contact
Nolwen LABORDE, MD principal investigator
University Hospital, Toulouse
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Diseases, run by University Hospital, Toulouse at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nolwenn LABORDE, MD (05 61 77 96 70, laborde.n@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of dental dyschromia (time frame: from birth to study completion, a maximum of 19 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.