Psycho-social Impact of Amelogenesis and Dentinogenesis Imperfecta

Completed

• Conditions: Amelogenesis Imperfecta; Dentinogenesis Imperfecta

• Registration Number: NCT04927962
• Lead Sponsor: University Hospital, Toulouse

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-09
• Study First Posted: 2021-06-16
• Study Start: 2021-09-22
• Primary Completion: 2024-04-03
• Study Completion: 2024-04-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Child Oral Health Impact Profile (COHIP)	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)

Trial Locations

Locations (7)

CHU de Bordeaux; 🇫🇷 Bordeaux, France

CHU de Nantes; 🇫🇷 Nantes, France

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France

AP-HM; 🇫🇷 Marseille, France

AP-HP; 🇫🇷 Paris, France

University hospital of Toulouse; 🇫🇷 Toulouse, France