Dental Management of Patients With HIV in Pays de la Loire (VIH-ODONTO)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV Infection; Acquired Immune Deficiency Syndrome; Oral Health Care
• Intervention / Treatment: Other: HIV infection status and clinical characteristics

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.

• Study Type: Observational
• Enrollment (Estimated): 5603

Contacts and Locations

• Study Contact: Name: Alexandra Poinas, PhD; Phone Number: +33 2 53 48 28 57; Email: alexandra.poinas@chu-nantes.fr
• Study Contact Backup: Name: Gilles Amador del Valle, MD, PhD; Phone Number: +33 2 40 08 31 73; Email: gilles.amadordelvalle@univ-nantes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients living with HIV followed in hospital-based infectious diseases departments in France, identified retrospectively from routine clinical records and biological databases.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients With HIV; Patients living with HIV included in a retrospective cohort using anonymized data from the COREVIH Pays de la Loire database. The study population includes adults followed in routine clinical care, with available demographic, clinical, biological, and comorbidity data used to assess factors relevant to dental management.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients Requiring Adapted Dental Management	Percentage of patients living with HIV presenting at least one biological abnormality associated with increased risk of infectious or hemorrhagic complications during invasive dental procedures, including low CD4 count, neutropenia, thrombocytopenia, or anemia, based on routinely collected clinical data.	At time of data extraction (retrospective baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CD4 Cell Count Distribution	CD4 lymphocyte count (cells/mm³) distribution among patients, used to assess immune status. Lower values indicate greater immunosuppression.	At time of data extraction (retrospective baseline)
Neutrophil Count Distribution	Neutrophil count (cells/mm³) measured from routine blood tests. Lower values indicate increased risk of infection.	At time of data extraction (retrospective baseline)
Platelet Count Distribution	Platelet count (×10⁹/L) measured from routine blood tests. Lower values indicate increased bleeding risk.	At time of data extraction (retrospective baseline)
Hemoglobin Level Distribution	Hemoglobin level (g/dL) measured from routine blood tests. Lower values indicate anemia.	At time of data extraction (retrospective baseline)
Prevalence of Comorbidities	Percentage of patients presenting comorbid conditions (e.g., diabetes, cardiovascular disease, renal disease, depression) that may impact dental management.	At time of data extraction (retrospective baseline)
Viral Load Status	Proportion of patients with detectable versus undetectable HIV viral load, based on routine clinical measurements.	At time of data extraction (retrospective baseline)

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 2, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: April 20, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: AP_GADV_SG_VIH-ODONTO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No