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Recruiting NCT07552038

Dental Management of Patients With HIV in Pays de la Loire

— Observational HIV Infection Acquired Immune Deficiency Syndrome Oral Health Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HIV infection status and clinical characteristics.
Who it may be relevant to
Registry conditions: HIV Infection, Acquired Immune Deficiency Syndrome, Oral Health Care. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Dental Management of Patients Living With HIV: A Retrospective Study Using COREVIH Data in Pays de la Loire

Overview

Dental care for people living with HIV has evolved with the widespread use of antiretroviral therapy, which has improved life expectancy and disease control. However, uncertainty remains about whether specific adaptations are still needed during dental procedures due to potential biological abnormalities that may increase infectious or bleeding risks. This study aims to evaluate the proportion of patients living with HIV in the Pays de la Loire region who may require adapted dental management based on biological parameters such as immune status, hematological values, and comorbidities. A retrospective descriptive study will be conducted using anonymized data from 5,603 patients followed in the COREVIH Pays de la Loire database. The results are expected to provide objective data to better inform dental practice and reduce unnecessary precautions or stigmatization in the management of patients living with HIV.

Detailed description

This is a retrospective descriptive observational study using anonymized data from patients living with HIV followed in the Pays de la Loire region. The dataset includes 5,603 individuals whose data were previously collected as part of routine clinical care and recorded in the Nadis medical database by healthcare professionals involved in HIV management.

Data were provided by the COREVIH Pays de la Loire in an anonymized format and include demographic characteristics (age, sex), HIV-related variables (viral load, duration since diagnosis, antiretroviral therapy status), co-infections (sexually transmitted infections and hepatitis B/C), biological parameters (CD4 lymphocyte count, neutrophil count, platelet count, hemoglobin level), and comorbidities (e.g., diabetes, hypertension, renal disease, cardiovascular conditions, depression).

The primary objective is to determine the proportion of patients presenting biological abnormalities that may increase the risk of infectious or hemorrhagic complications during invasive dental procedures.

Data analysis will consist of descriptive statistics, including frequencies and percentages for categorical variables. The study does not involve any intervention, additional data collection, or direct patient contact.

All data are fully anonymized prior to analysis, ensuring that participants cannot be identified. The study complies with applicable data protection regulations and is based on previously collected clinical data.

Interventions

  • Other HIV infection status and clinical characteristics
    Observational assessment of clinical, biological, and comorbidity data in patients living with HIV, including CD4 count, viral load, hematological parameters, and associated conditions, collected from routine care without any intervention.

Primary outcome measures

  • Proportion of Patients Requiring Adapted Dental Management [Time frame: At time of data extraction (retrospective baseline)]
Secondary outcome measures (6)
  • CD4 Cell Count Distribution [Time frame: At time of data extraction (retrospective baseline)]
  • Neutrophil Count Distribution [Time frame: At time of data extraction (retrospective baseline)]
  • Platelet Count Distribution [Time frame: At time of data extraction (retrospective baseline)]
  • Hemoglobin Level Distribution [Time frame: At time of data extraction (retrospective baseline)]
  • Prevalence of Comorbidities [Time frame: At time of data extraction (retrospective baseline)]
  • Viral Load Status [Time frame: At time of data extraction (retrospective baseline)]

Eligibility criteria

Inclusion criteria

  • Adult patients aged ≥18 years
  • Confirmed diagnosis of HIV infection
  • Followed at participating hospital centers
  • Available clinical and biological data relevant to dental care management (CD4 count, viral load, blood count)

Exclusion criteria

  • Patients with missing key biological data required for analysis
  • Patients not followed in participating centers
  • Patients with incomplete medical records preventing assessment of outcomes

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • CHU Nantes-Department of Dentistry — Nantes

Identifiers

NCT: NCT07552038 · AP_GADV_SG_VIH-ODONTO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗