The Impact of Oral Health in HIV Patients on Antiretroviral Therapy
NCT ID: NCT04645693
Last Updated: 2025-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
350 participants
OBSERVATIONAL
2021-02-24
2026-03-31
Brief Summary
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Detailed Description
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Following enrollment in study, patients will be followed up every 6 months for approximately 2.5 years (30 months). During this period, comprehensive medical records will be obtained, and study data will be updated every 6 months; questionnaires will be handed to patients periodically to assess quality of life and effects of xerostomia on QoL; social history will be assessed using TAPS; oral health will be evaluated every 6 months and blood, saliva, and oral swabs collected every 6 months. DXA scan and panoramic radiographs will also be taken at baseline and 24 months.
At the end of the study, caries rate, periodontal health, bone loss, QoL, salivary quantity and composition, presence or absence of white/red lesions, as well as inflammatory cytokines and immune activation markers will be assessed.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HIV Subjects with Non-Communicable Diseases
Patients living with HIV on Antiretroviral Therapy drugs for at least one year with no diagnosis of non-communicable diseases (diabetes, insulin resistance, hyperlipidemia/dyslipidemia, vascular disease, and/or osteoporosis).
No interventions assigned to this group
HIV Subjects without Non-Communicable Diseases
Patients living with HIV on Antiretroviral Therapy drugs for at least one year with a diagnosis of one or more systemic non-communicable diseases (diabetes, insulin resistance, hyperlipidemia/dyslipidemia, vascular disease, and/or osteoporosis).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Has been diagnosed with HIV (as documented by a prior laboratory report of positive HIV-1/2 antibody and/or detectable HIV RNA, available for review by the study team)
* Has received antiretroviral therapy for at least 12 months
* Able and willing to provide informed consent prior to initiation of study procedures
* Willing and able to comply with all study procedures, and likely to be available for the duration of the study
Exclusion Criteria
* Has never received radiation therapy to the head or neck (including radioactive iodine therapy)
* Was taking anti-osteoporotic agents (biphosphonates, denosumab) prior to HIV diagnosis.
* Women who are pregnant at the time of enrollment.
18 Years
ALL
No
Sponsors
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National Institute of Dental and Craniofacial Research (NIDCR)
NIH
University of Pennsylvania
OTHER
Responsible Party
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Temitope Omolehinwa, BDS, DScD
Assistant Professor of Oral Medicine
Principal Investigators
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Temitope Omolehinwa, BDS, DScD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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University of Pennsylvania School of Dental Medicine
Philadelphia, Pennsylvania, United States
Countries
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References
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Omolehinwa TT, Akintoye SO, Gabinskiy M, Lo Re V 3rd, Mupparapu M, Urbina R, Schaubel DE, Corby PM. Oral health outcomes in an HIV cohort with comorbidities- implementation roadmap for a longitudinal prospective observational study. BMC Oral Health. 2023 Oct 17;23(1):763. doi: 10.1186/s12903-023-03527-5.
Other Identifiers
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843328
Identifier Type: -
Identifier Source: org_study_id
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