Psycho-social Impact of Amelogenesis and Dentinogenesis Imperfecta (AiDiBull)

April 30, 2025 updated by: University Hospital, Toulouse

Psycho-social Impact of Amelogenesis and Dentinogenesis Imperfecta in Young People

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

87

Contacts and Locations

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

Study Locations

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

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

10 years to 18 years (Child, Adult)

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.

Description

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:

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child Oral Health Impact Profile (COHIP)
Time Frame: Baseline
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

Collaborators and Investigators

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

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Frédéric VAYSSE, University Hospital of 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)

September 22, 2021

Primary Completion (Actual)

April 3, 2024

Study Completion (Actual)

April 3, 2024

Study Registration Dates

First Submitted

June 9, 2021

First Submitted That Met QC Criteria

June 9, 2021

First Posted (Actual)

June 16, 2021

Study Record Updates

Last Update Posted (Actual)

May 4, 2025

Last Update Submitted That Met QC Criteria

April 30, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/20/0255

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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