The Impact of Oral Health in HIV Patients on Antiretroviral Therapy

HIV Clinical Trial

— OHART  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04645693
• Other study ID #: 843328
• Secondary ID: R01DE029648-01
• Status: Recruiting
• Start date: February 24, 2021
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: University of Pennsylvania
• Contact: Temitope Omolehinwa
• Phone: 2159085667
• Email: PDM-OHART[@]dental.upenn.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Caries
• HIV
• Non-communicable Disease
• Noncommunicable Diseases
• Periodontal Diseases
• Xerostomia

Locations

Country	Name	City	State
United States	University of Pennsylvania School of Dental Medicine	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	6 months after baseline visit
Primary	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.	12 months after baseline visit
Primary	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.	18 months after baseline visit
Primary	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.	24 months after baseline visit
Primary	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.	30 months after baseline visit
Primary	Periodontal disease	Incidence of periodontal disease	Baseline
Primary	Periodontal disease	Incidence of periodontal disease	12 months after baseline visit
Primary	Periodontal disease	Incidence of periodontal disease	24 months after baseline visit
Primary	Periodontal disease	Incidence of periodontal disease	30 months after baseline visit
Primary	Oral mucosal lesions coinfection as assessed by the presence or absence of candidiasis, red/white lesions, ulcers and warts intraorally	Prescence or absence of warts, red or white lesions and candidia	Baseline
Primary	Oral mucosal lesions coinfection as assessed by the presence or absence of candidiasis, red/white lesions, ulcers and warts intraorally	Prescence or absence of warts, red or white lesions and candidia	6 months after baseline visit
Primary	Oral mucosal lesions coinfection as assessed by the presence or absence of candidiasis, red/white lesions, ulcers and warts intraorally	Prescence or absence of warts, red or white lesions and candidia	12 months after baseline visit
Primary	Oral mucosal lesions coinfection as assessed by the presence or absence of candidiasis, red/white lesions, ulcers and warts intraorally	Prescence or absence of warts, red or white lesions and candidia	18 months after baseline visit
Primary	Oral mucosal lesions coinfection as assessed by the presence or absence of candidiasis, red/white lesions, ulcers and warts intraorally	Prescence or absence of warts, red or white lesions and candidia	24 months after baseline visit
Primary	Oral mucosal lesions coinfection as assessed by the presence or absence of candidiasis, red/white lesions, ulcers and warts intraorally	Prescence or absence of warts, red or white lesions and candidia	30 months after baseline visit
Primary	Osteopenia as assessed by DXA scan findings	Incidence of osteopenia	Baseline
Primary	Osteopenia as assessed by DXA scan findings	Incidence of osteopenia	24 months after baseline visit
Primary	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.	Baseline
Primary	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.	12 months after baseline visit
Primary	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.	24 months after baseline visit
Primary	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.	30 months after baseline visit
Primary	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.	Baseline
Primary	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.	12 months after baseline visit
Primary	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.	24 months after baseline visit
Primary	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.	30 months after baseline visit
Primary	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).	Baseline
Primary	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).	12 months after baseline visit
Primary	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).	24 months after baseline visit
Primary	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).	30 months after baseline visit
Secondary	Xerostomia as assessed by stimulated saliva secretion rate	Prevalence of xerostomia	Baseline
Secondary	Xerostomia as assessed by stimulated saliva secretion rate	Prevalence of xerostomia	6 months after baseline visit
Secondary	Xerostomia as assessed by stimulated saliva secretion rate	Prevalence of xerostomia	12 months after baseline visit
Secondary	Xerostomia as assessed by stimulated saliva secretion rate	Prevalence of xerostomia	18 months after baseline visit
Secondary	Xerostomia as assessed by stimulated saliva secretion rate	Prevalence of xerostomia	24 months after baseline visit
Secondary	Xerostomia as assessed by stimulated saliva secretion rate	Prevalence of xerostomia	30 months after baseline visit
Secondary	Saliva proteins	levels of amylase expression will be assessed	Baseline
Secondary	Saliva proteins	levels of amylase expression will be assessed	6 months after baseline visit
Secondary	Saliva proteins	levels of amylase expression will be assessed	12 months after baseline visit
Secondary	Saliva proteins	levels of amylase expression will be assessed	18 months after baseline visit
Secondary	Saliva proteins	levels of amylase expression will be assessed	24 months after baseline visit
Secondary	Saliva proteins	levels of amylase expression will be assessed	30 months after baseline visit
Secondary	Saliva proteins	levels of IgA expression will be assessed	baseline visit
Secondary	Saliva proteins	levels of IgA expression will be assessed	6 months after baseline visit
Secondary	Saliva proteins	levels of IgA expression will be assessed	12 months after baseline visit
Secondary	Saliva proteins	levels of IgA expression will be assessed	18 months after baseline visit
Secondary	Saliva proteins	levels of IgA expression will be assessed	24 months after baseline visit
Secondary	Saliva proteins	levels of IgA expression will be assessed	30 months after baseline visit
Secondary	Correlative measures	Salivary cytokines: levels of IL-6, IL-7, IL-10, TNF-a, neopterin, ß-2-microglobulin (ß2M) and monocyte chemotactic protein-1 will be assessed	Baseline through 30 months