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CompletedNCT04927962AiDiBullUpdated May 4, 2025

Psycho-social Impact of Amelogenesis and Dentinogenesis Imperfecta

An observational study in Dentinogenesis Imperfecta and Amelogenesis Imperfecta, sponsored by University Hospital, Toulouse. Completed at 7 sites in France. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-05-04.

Sponsored by University Hospital, Toulouse · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
87
Ages
10 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Dentinogenesis Imperfecta
  • Amelogenesis Imperfecta

Keywords

  • Amelogenesis imperfecta
  • Dentinogenesis imperfecta
  • Bullying
  • Oral health related quality of life
  • Dental anxiety
03

Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Child presenting for diagnostic consultation and child who cannot read or whose 2 parents (legal representatives) cannot read
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
87 participants (actual)
Patient registry
No

Interventions

  • OtherQuestionnaires

    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).

05

What researchers measure

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)

    Time frame: Baseline

06

Study locations

7 sites
  • CHU de Bordeaux
    Bordeaux, 33000, France
  • Hospices Civils de Lyon
    Lyon, 69365, France
  • AP-HM
    Marseille, 13385, France
  • CHU de Nantes
    Nantes, 44000, France
  • AP-HP
    Paris, 75012, France
  • Hôpitaux Universitaires de Strasbourg
    Strasbourg, 67091, France
  • University hospital of Toulouse
    Toulouse, 31059, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04927962
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Jun 16, 2021
Start date
Sep 22, 2021
Primary completion
Apr 3, 2024
Completion
Apr 3, 2024
Last update
May 4, 2025

Study contacts

Frédéric VAYSSE
principal investigator · University hospital of Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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