Psycho-social Impact of Amelogenesis and Dentinogenesis Imperfecta

Amelogenesis Imperfecta Clinical Trial

— AiDiBull  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04927962
• Other study ID #: RC31/20/0255
• Status: Recruiting
• Start date: September 22, 2021
• Est. completion date: June 2023

Study information

• Verified date: August 2022
• Source: University Hospital, Toulouse
• Contact: Emmanuelle Noirrit-Esclassan
• Phone: 0561778378
• Email: noirrit.e[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Amelogenesis Imperfecta
• Dentinogenesis Imperfecta

Intervention

Other:
• Questionnaires
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).

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux
France	Hospices Civils de Lyon	Lyon
France	AP-HM	Marseille
France	CHU de Nantes	Nantes
France	AP-HP	Paris
France	Hôpitaux Universitaires de Strasbourg	Strasbourg
France	University hospital of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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