HIVOHARTNCT04645693
The Impact of Oral Health in HIV Patients on Antiretroviral Therapy
An observational study of HIV and Periodontal Diseases, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Periodontal Diseases, Caries
- How many people
- 227 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2021to 28 Feb 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients living with HIV above the age of 18 will be enrolled in this study.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania School of Dental Medicine
Philadelphia, Pennsylvania, 19104
About this study
Official title: The Impact of Oral Health on Metabolism and Persistent Inflammation 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.
Read the detailed description
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.
- Conditions
- HIV, Periodontal Diseases, Caries, Non-communicable Disease, Xerostomia
- Medical subject headings
- Periodontal Diseases, Noncommunicable Diseases, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). | |
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months after baseline visit
Periodontal disease
Incidence of periodontal disease
Measured: Baseline
Periodontal disease
Incidence of periodontal disease
Measured: 12 months after baseline visit
Periodontal disease
Incidence of periodontal disease
Measured: 24 months after baseline visit
Osteopenia as assessed by DXA scan findings
Incidence of osteopenia
Measured: Baseline
Osteopenia as assessed by DXA scan findings
Incidence of osteopenia
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 24 months after baseline visit
Secondary outcomes (5)
Xerostomia as assessed by stimulated saliva secretion rate
Prevalence of xerostomia
Measured: Baseline
Xerostomia as assessed by stimulated saliva secretion rate
Prevalence of xerostomia
Measured: 6 months after baseline visit
Xerostomia as assessed by stimulated saliva secretion rate
Prevalence of xerostomia
Measured: 12 months after baseline visit
Xerostomia as assessed by stimulated saliva secretion rate
Prevalence of xerostomia
Measured: 18 months after baseline visit
Xerostomia as assessed by stimulated saliva secretion rate
Prevalence of xerostomia
Measured: 24 months after baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start24 Feb 2021
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 227 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Temitope Omolehinwa, BDS, DScD, University of Pennsylvania
- Investigators
- Temitope Omolehinwa, BDS, DScD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645693
- Sponsor's protocol ID
- 843328
- Other IDs
- R01DE029648-01
- Acronym
- OHART
- Status last verified
- Apr 2026
- First submitted
- 1 Oct 2020
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37848867
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Oral Health on Metabolism and Persistent Inflammation in HIV Patients on Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT04645693
- Acronym / sponsor ID
- OHART / 843328
- Conditions
- HIV, Periodontal Diseases, Caries, Non-communicable Disease, Xerostomia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 27 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients living with HIV above the age of 18 will be enrolled in this study.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
Periodontal disease
Time frame: Baseline
Incidence of periodontal disease
Periodontal disease
Time frame: 12 months after baseline visit
Incidence of periodontal disease
Periodontal disease
Time frame: 24 months after baseline visit
Incidence of periodontal disease
Osteopenia as assessed by DXA scan findings
Time frame: Baseline
Incidence of osteopenia
Osteopenia as assessed by DXA scan findings
Time frame: 24 months after baseline visit
Incidence of osteopenia
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.
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.
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.
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.
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.
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.
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).
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).
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).
5 secondary outcomes
Xerostomia as assessed by stimulated saliva secretion rate
Time frame: Baseline
Xerostomia as assessed by stimulated saliva secretion rate
Time frame: 6 months after baseline visit
Xerostomia as assessed by stimulated saliva secretion rate
Time frame: 12 months after baseline visit
Xerostomia as assessed by stimulated saliva secretion rate
Time frame: 18 months after baseline visit
Xerostomia as assessed by stimulated saliva secretion rate
Time frame: 24 months after baseline visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Derived from this study: PubMed 37848867Omolehinwa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Temitope Omolehinwa, BDS, DScD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Periodontal Diseases, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental Caries as assessed by DMFS Score (time frame: Baseline). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04645693, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.