NCT04927962

Brief Summary

The purpose of this research is to study the impact of dentinogenesis (DI) and amelogenesis (AI) imperfecta on oral quality of life, exposure to bullying and dental anxiety in a population of adolescents. WThe present study will use validated scales to evaluate the impact of bullying on the oral quality of live of youth aged 10 to 18 years, with non-syndromic DI or AI treated in seven national competence or reference centers in rare oral diseases.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

September 22, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2024

Completed
Last Updated

May 4, 2025

Status Verified

April 1, 2025

Enrollment Period

2.5 years

First QC Date

June 9, 2021

Last Update Submit

April 30, 2025

Conditions

Dentinogenesis ImperfectaAmelogenesis Imperfecta

Keywords

Amelogenesis imperfectaDentinogenesis imperfectaBullyingOral health related quality of lifeDental anxiety

Outcome Measures

Primary Outcomes (1)

  • Child Oral Health Impact Profile (COHIP)

    Difference between the average total COHIP questionnaire score of bullied and non bullied patients at D0 (no follow up is planned). A youth is considered bullied if he or she answers "three or more" at least once on the Bullying and Cyberbullying scale for Adolescent questionnaire)

    Baseline

Interventions

QuestionnairesOTHER

For youth: self-reported questionnaires (on oral quality of life, bullying and cyberbullying, dental anxiety) and routine clinical examination for adolescents. For one parent: self-reported questionnaires (on perceived oral quality of life of their child and on their own dental anxiety).

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients having a non-syndromic amelogenesis imperfecta or dentinogenesis imperfecta and consulting for a care or follow-up consultation.

You may qualify if:

  • be between 10 and 18 years of age,
  • consult for a care or follow-up consultation
  • having a non-syndromic amelogenesis imperfecta or dentinogenesis imperfecta
  • having access to a cell phone and/or tablet and/or personal or family computer
  • covered by the social security of one of his parents
  • understand French and one of whose parents (or legal representative) understands French
  • have declared his or her non-opposition and one of whose parents (or legal representative) has declared his or her non-opposition to participate in the study.

You may not qualify if:

  • Child presenting for diagnostic consultation and child who cannot read or whose 2 parents (legal representatives) cannot read

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

CHU de Bordeaux

Bordeaux, 33000, France

Location

Hospices Civils de Lyon

Lyon, 69365, France

Location

AP-HM

Marseille, 13385, France

Location

CHU de Nantes

Nantes, 44000, France

Location

AP-HP

Paris, 75012, France

Location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

University hospital of Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Dentinogenesis ImperfectaAmelogenesis ImperfectaBullying

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Tooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDevelopmental Defects of EnamelAggressionBehavioral SymptomsBehaviorHarassment, Non-SexualSocial Behavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Frédéric VAYSSE

    University hospital of Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2021

First Posted

June 16, 2021

Study Start

September 22, 2021

Primary Completion

April 3, 2024

Study Completion

April 3, 2024

Last Updated

May 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(7)