An observational study in HIV, Periodontal Diseases and Caries, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by University of Pennsylvania · Observational
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.
This is a prospective cohort study designed to investigate the range of metabolic abnormalities observed in patients living with HIV (PLWH) on antiretroviral therapy (ART). This study will also explore the concurrent role of poor oral health in supporting and driving chronic immune activation and inflammation in HIV infection.
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.
830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.
This study's enrollment of 227 is above the median of 100 across 291 observational studies indexed under Periodontal Diseases.
Browse Periodontal Diseases studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients living with HIV above the age of 18 will be enrolled in this study.
Exclusion Criteria:
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).
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).
Dental Caries as assessed by DMFS Score
Decayed, missing and filled surfaces (DMFS) score to assess dental caries. Minimum value is 0 and maximum value is 128 for 28 teeth. Higher scores mean higher levels of dental decay.
Time frame: Baseline
Dental Caries as assessed by DMFS Score
Decayed, missing and filled surfaces (DMFS) score to assess dental caries. Minimum value is 0 and maximum value is 128 for 28 teeth. Higher scores mean higher levels of dental decay.
Time frame: 6 months after baseline visit
Dental Caries as assessed by DMFS Score
Decayed, missing and filled surfaces (DMFS) score to assess dental caries. Minimum value is 0 and maximum value is 128 for 28 teeth. Higher scores mean higher levels of dental decay.
Time frame: 12 months after baseline visit
Dental Caries as assessed by DMFS Score
Decayed, missing and filled surfaces (DMFS) score to assess dental caries. Minimum value is 0 and maximum value is 128 for 28 teeth. Higher scores mean higher levels of dental decay.
Time frame: 18 months after baseline visit
Dental Caries as assessed by DMFS Score
Decayed, missing and filled surfaces (DMFS) score to assess dental caries. Minimum value is 0 and maximum value is 128 for 28 teeth. Higher scores mean higher levels of dental decay.
Time frame: 24 months after baseline visit
Periodontal disease
Incidence of periodontal disease
Time frame: Baseline
Periodontal disease
Incidence of periodontal disease
Time frame: 12 months after baseline visit
Periodontal disease
Incidence of periodontal disease
Time frame: 24 months after baseline visit
Osteopenia as assessed by DXA scan findings
Incidence of osteopenia
Time frame: Baseline
Osteopenia as assessed by DXA scan findings
Incidence of osteopenia
Time frame: 24 months after baseline visit
Quality of life as assessed by the Xerostomia Quality of Life Scale (XeQoLS)
The XeQoLS consists of 15 questions. The first 14 questions assess how dryness in the mouth impacts the individual's life, with answer options of "not at all," "a little," "somewhat," "quite a bit," and "very much." The final question asks "if you were to spend the rest of your life with your dry mouth/throat dryness just the way it is now, how would you feel about this?" and includes options ranging from "delighted" to "terrible." All 15 questions can be translated to a score of 0-4, with a score of 4 indicating the most dry mouth-related problems and 0 indicating no dry mouth-related problems.
Time frame: Baseline
Quality of life as assessed by the Xerostomia Quality of Life Scale (XeQoLS)
The XeQoLS consists of 15 questions. The first 14 questions assess how dryness in the mouth impacts the individual's life, with answer options of "not at all," "a little," "somewhat," "quite a bit," and "very much." The final question asks "if you were to spend the rest of your life with your dry mouth/throat dryness just the way it is now, how would you feel about this?" and includes options ranging from "delighted" to "terrible." All 15 questions can be translated to a score of 0-4, with a score of 4 indicating the most dry mouth-related problems and 0 indicating no dry mouth-related problems.
Time frame: 12 months after baseline visit
Quality of life as assessed by the Xerostomia Quality of Life Scale (XeQoLS)
The XeQoLS consists of 15 questions. The first 14 questions assess how dryness in the mouth impacts the individual's life, with answer options of "not at all," "a little," "somewhat," "quite a bit," and "very much." The final question asks "if you were to spend the rest of your life with your dry mouth/throat dryness just the way it is now, how would you feel about this?" and includes options ranging from "delighted" to "terrible." All 15 questions can be translated to a score of 0-4, with a score of 4 indicating the most dry mouth-related problems and 0 indicating no dry mouth-related problems.
Time frame: 24 months after baseline visit
Quality of life as assessed by the Oral Health Related Quality of Life (OHRQoL)
Oral health related quality of life will be assessed using the questionnaire developed for the National Health and Nutrition Examination Survey (NHANES). This questionnaire assesses the topic areas of last visit to dentist or lack of dental care; direct conversation with dental professional about your dental health; dental health perception; oral cancer exam; use of dental floss or dental rinse product; and periodontal disease self-report. Each topic area uses a separate scoring system and may be assessed individually.
Time frame: Baseline
Quality of life as assessed by the Oral Health Related Quality of Life (OHRQoL)
Oral health related quality of life will be assessed using the questionnaire developed for the National Health and Nutrition Examination Survey (NHANES). This questionnaire assesses the topic areas of last visit to dentist or lack of dental care; direct conversation with dental professional about your dental health; dental health perception; oral cancer exam; use of dental floss or dental rinse product; and periodontal disease self-report. Each topic area uses a separate scoring system and may be assessed individually.
Time frame: 12 months after baseline visit
Quality of life as assessed by the Oral Health Related Quality of Life (OHRQoL)
Oral health related quality of life will be assessed using the questionnaire developed for the National Health and Nutrition Examination Survey (NHANES). This questionnaire assesses the topic areas of last visit to dentist or lack of dental care; direct conversation with dental professional about your dental health; dental health perception; oral cancer exam; use of dental floss or dental rinse product; and periodontal disease self-report. Each topic area uses a separate scoring system and may be assessed individually.
Time frame: 24 months after baseline visit
Quality of life as assessed by the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tool
The TAPS tool screens for substance use (including tobacco, alcohol, prescription medication, and other drugs) and includes a brief assessment of abuse risk for those who screen positive. Individuals who screen positive for use of any of the substances are then scored as 0 (no use in the past 3 months), 1 (problem use), and 2+ (high risk for substance use disorder).
Time frame: Baseline
Quality of life as assessed by the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tool
The TAPS tool screens for substance use (including tobacco, alcohol, prescription medication, and other drugs) and includes a brief assessment of abuse risk for those who screen positive. Individuals who screen positive for use of any of the substances are then scored as 0 (no use in the past 3 months), 1 (problem use), and 2+ (high risk for substance use disorder).
Time frame: 12 months after baseline visit
Quality of life as assessed by the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tool
The TAPS tool screens for substance use (including tobacco, alcohol, prescription medication, and other drugs) and includes a brief assessment of abuse risk for those who screen positive. Individuals who screen positive for use of any of the substances are then scored as 0 (no use in the past 3 months), 1 (problem use), and 2+ (high risk for substance use disorder).
Time frame: 24 months after baseline visit
Xerostomia as assessed by stimulated saliva secretion rate
Prevalence of xerostomia
Time frame: Baseline
Xerostomia as assessed by stimulated saliva secretion rate
Prevalence of xerostomia
Time frame: 6 months after baseline visit
Xerostomia as assessed by stimulated saliva secretion rate
Prevalence of xerostomia
Time frame: 12 months after baseline visit
Xerostomia as assessed by stimulated saliva secretion rate
Prevalence of xerostomia
Time frame: 18 months after baseline visit
Xerostomia as assessed by stimulated saliva secretion rate
Prevalence of xerostomia
Time frame: 24 months after baseline visit
Plan to share: No
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