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NCT Number: NCT07552038

Dental Management of Patients With HIV 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HIV infection status and clinical characteristics

Other

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 outcomes

  1. Proportion of Patients Requiring Adapted Dental Management

    Time frame: At time of data extraction (retrospective baseline)

    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.

Secondary outcomes

  1. CD4 Cell Count Distribution

    Time frame: At time of data extraction (retrospective baseline)

    CD4 lymphocyte count (cells/mm³) distribution among patients, used to assess immune status. Lower values indicate greater immunosuppression.

  2. Neutrophil Count Distribution

    Time frame: At time of data extraction (retrospective baseline)

    Neutrophil count (cells/mm³) measured from routine blood tests. Lower values indicate increased risk of infection.

  3. Platelet Count Distribution

    Time frame: At time of data extraction (retrospective baseline)

    Platelet count (×10⁹/L) measured from routine blood tests. Lower values indicate increased bleeding risk.

  4. Hemoglobin Level Distribution

    Time frame: At time of data extraction (retrospective baseline)

    Hemoglobin level (g/dL) measured from routine blood tests. Lower values indicate anemia.

  5. Prevalence of Comorbidities

    Time frame: At time of data extraction (retrospective baseline)

    Percentage of patients presenting comorbid conditions (e.g., diabetes, cardiovascular disease, renal disease, depression) that may impact dental management.

  6. Viral Load Status

    Time frame: At time of data extraction (retrospective baseline)

    Proportion of patients with detectable versus undetectable HIV viral load, based on routine clinical measurements.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Poinas, PhD

CONTACT

[email protected]

+33 2 53 48 28 57

Gilles Amador del Valle, MD, PhD

CONTACT

[email protected]

+33 2 40 08 31 73

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: VIH-ODONTO

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 27, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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