The Impact of Oral Health on Metabolism and Persistent Inflammation in HIV Patients on Antiretroviral Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 227
- 试验地点
- 1
- 主要终点
- Osteopenia as assessed by DXA scan findings
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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).
结局指标
主要结局
Osteopenia as assessed by DXA scan findings
时间窗: 24 months after baseline visit
Incidence of osteopenia
Dental Caries as assessed by DMFS Score
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
Periodontal disease
时间窗: Baseline
Incidence of periodontal disease
Dental Caries as assessed by DMFS Score
时间窗: 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
时间窗: 12 months after baseline visit
Incidence of periodontal disease
Periodontal disease
时间窗: 24 months after baseline visit
Incidence of periodontal disease
Osteopenia as assessed by DXA scan findings
时间窗: Baseline
Incidence of osteopenia
Quality of life as assessed by the Xerostomia Quality of Life Scale (XeQoLS)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- Xerostomia as assessed by stimulated saliva secretion rate(Baseline)
- Xerostomia as assessed by stimulated saliva secretion rate(6 months after baseline visit)
- Xerostomia as assessed by stimulated saliva secretion rate(12 months after baseline visit)
- Xerostomia as assessed by stimulated saliva secretion rate(18 months after baseline visit)
- Xerostomia as assessed by stimulated saliva secretion rate(24 months after baseline visit)
研究者
Temitope Omolehinwa, BDS, DScD
Assistant Professor of Oral Medicine
University of Pennsylvania