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NCT Number: NCT04645693

The Impact of Oral Health in HIV Patients on Antiretroviral Therapy

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.

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Key information

Conditions

HIV Caries Disease Attributes Mouth Diseases Non-communicable Disease Noncommunicable Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Salivary Gland Diseases Stomatognathic Diseases Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pennsylvania School of Dental Medicine

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Dental Caries as assessed by DMFS Score

    Time frame: Baseline

    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.

  2. Dental Caries as assessed by DMFS Score

    Time frame: 6 months after baseline visit

    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.

  3. Dental Caries as assessed by DMFS Score

    Time frame: 12 months after baseline visit

    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.

  4. Dental Caries as assessed by DMFS Score

    Time frame: 18 months after baseline visit

    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.

  5. Dental Caries as assessed by DMFS Score

    Time frame: 24 months after baseline visit

    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.

  6. Periodontal disease

    Time frame: Baseline

    Incidence of periodontal disease

  7. Periodontal disease

    Time frame: 12 months after baseline visit

    Incidence of periodontal disease

  8. Periodontal disease

    Time frame: 24 months after baseline visit

    Incidence of periodontal disease

  9. Osteopenia as assessed by DXA scan findings

    Time frame: Baseline

    Incidence of osteopenia

  10. Osteopenia as assessed by DXA scan findings

    Time frame: 24 months after baseline visit

    Incidence of osteopenia

  11. Quality of life as assessed by the Xerostomia Quality of Life Scale (XeQoLS)

    Time frame: Baseline

    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.

  12. Quality of life as assessed by the Xerostomia Quality of Life Scale (XeQoLS)

    Time frame: 12 months after baseline visit

    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.

  13. Quality of life as assessed by the Xerostomia Quality of Life Scale (XeQoLS)

    Time frame: 24 months after baseline visit

    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.

  14. Quality of life as assessed by the Oral Health Related Quality of Life (OHRQoL)

    Time frame: Baseline

    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.

  15. Quality of life as assessed by the Oral Health Related Quality of Life (OHRQoL)

    Time frame: 12 months after baseline visit

    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.

  16. Quality of life as assessed by the Oral Health Related Quality of Life (OHRQoL)

    Time frame: 24 months after baseline visit

    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.

  17. Quality of life as assessed by the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tool

    Time frame: Baseline

    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).

  18. Quality of life as assessed by the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tool

    Time frame: 12 months after baseline visit

    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).

  19. Quality of life as assessed by the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tool

    Time frame: 24 months after baseline visit

    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).

Secondary outcomes

  1. Xerostomia as assessed by stimulated saliva secretion rate

    Time frame: Baseline

    Prevalence of xerostomia

  2. Xerostomia as assessed by stimulated saliva secretion rate

    Time frame: 6 months after baseline visit

    Prevalence of xerostomia

  3. Xerostomia as assessed by stimulated saliva secretion rate

    Time frame: 12 months after baseline visit

    Prevalence of xerostomia

  4. Xerostomia as assessed by stimulated saliva secretion rate

    Time frame: 18 months after baseline visit

    Prevalence of xerostomia

  5. Xerostomia as assessed by stimulated saliva secretion rate

    Time frame: 24 months after baseline visit

    Prevalence of xerostomia

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

The Impact of Oral Health on Metabolism and Persistent Inflammation in HIV Patients on Antiretroviral Therapy

Acronym: OHART

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 27, 2020
Registry last updated
May 5, 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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