CompletedNot Applicable

The Impact of Oral Health in HIV Patients on Antiretroviral Therapy

United States227 participantsStarted 2021-02-24

Plain-language summary

This is a prospective cohort study designed to investigate the range of metabolic abnormalities observed in patients living with HIV on antiretroviral therapy. This study will also explore the concurrent role of poor oral health in supporting and driving chronic immune activation and inflammation in HIV infection.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥18 years * 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 been diagnosed with the following xerostomia-related autoimmune conditions: Sjorgen's and sarcoidosis * 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.

What they're measuring

Dental Caries as assessed by DMFS Score

Timeframe: Baseline

Dental Caries as assessed by DMFS Score

Timeframe: 6 months after baseline visit

Dental Caries as assessed by DMFS Score

Timeframe: 12 months after baseline visit

Dental Caries as assessed by DMFS Score

Timeframe: 18 months after baseline visit

Dental Caries as assessed by DMFS Score

Timeframe: 24 months after baseline visit

Periodontal disease

Timeframe: Baseline

Periodontal disease

Timeframe: 12 months after baseline visit

Periodontal disease

Timeframe: 24 months after baseline visit

Trial details

NCT IDNCT04645693

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-02-28

View on ClinicalTrials.gov More HIV trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Dental Caries as assessed by DMFS Score

Timeframe: Baseline

Dental Caries as assessed by DMFS Score

Timeframe: 6 months after baseline visit

Dental Caries as assessed by DMFS Score

Timeframe: 12 months after baseline visit

Dental Caries as assessed by DMFS Score

Timeframe: 18 months after baseline visit

Dental Caries as assessed by DMFS Score

Timeframe: 24 months after baseline visit

Periodontal disease

Timeframe: Baseline

Periodontal disease

Timeframe: 12 months after baseline visit

Periodontal disease

Timeframe: 24 months after baseline visit