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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05123547
Other study ID # RNI 2021 JACOMET 3
Secondary ID 2021-A01831-40
Status Completed
Phase
First received
Last updated
Start date October 21, 2021
Est. completion date April 21, 2022

Study information

Verified date May 2022
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is perform to identify oral diseases of people living with HIV (PLWHIV) or co-infected with HBV or HCV.


Description:

In the purpose of identifying oral diseases of people living with HIV (PLWHIV) or co-infected with HBV or HCV, we would recruit from 15 10 2021 to 15 04 2022 affiliated to social security scheme PLWHIV adults followed-up in the infectious diseases department of Clermont-Ferrand university hospital who accept participate in order to propose dental individual clinical exams. Anonymous socio-demograpic, medical and dental data will be reported in Redcap. Primary outcomes are the number and type of pathologies identified linked to HIV or not. Statistical analysed will be performed with Stata software. The population will be described by associated numbers and percentages for the categorical variables and by the mean ± standard deviation or median [interquartile interval] for the quantitative variables, with respect to their statistical distribution.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date April 21, 2022
Est. primary completion date April 21, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patient infected with HIV or co-infected with HIV / HBV or HIV / HCV followed in the Infectious Diseases department of Clermont-Ferrand University Hospital and affiliated to a social security scheme. Exclusion Criteria: - Minor patient - Adult patient unable to express his non-opposition to participating in the study or patient who refuses to participate in the study.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU clermont-ferrand Clermont-Ferrand

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary description of oral disease linked to HIV or not. percentage of patients with oral disease linked to HIV and percentage of patients with oral disease not linked to HIV During the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand
Secondary Study the factors associated with the presence of oral pathologies linked to HIV. bivariate and multivariate analysis of demographic, immunovirologic factors and comorbidities associated to oral diseases linked to HIV During the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand
Secondary Study the factors associated with the presence of oral pathologies unrelated to HIV. bivariate and multivariate analysis of demographic, immunovirologic factors and comorbidities associated with the presence of oral pathologies unrelated to HIV During the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand
Secondary Compare the prevalence of oral pathologies linked or not to HIV with that found in a previous study carried out in 2003. comparison of prevalence of oral diseases in 2021 and those in 2003 in CHU Clermont Ferrand During the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand
Secondary List the course of dental care of these people during the last 3 years. % refusal care, % lost of dental follow-up During the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand
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