Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422695
Status:
COMPLETED
Last Update Posted:
2017-04-13
First Post:
2007-01-16
Brief Title:
Pain and Sensory Changes Assessment in HIV Patients
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Pain and Sensory Changes Assessment in HIV Patients A Model for Pain and Sensory Changes Related Compromised Immune System
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There are about 42 million people in the world afflicted with HIV or AIDS with about 1 million patients in the US
The epidemiology of orofacial pain has been reported extensively in the literature yet the prevalence severity and level of pain affecting the head face neck and intraoral structures has not been explored in a population of HIV infected individuals
Pain in general terms is a common experience in HIV infected patients even in the absence of cancer or opportunistic infections There is a variation in the prevalence of pain in these individuals depending on the stage of disease care setting and study methods The purpose of this study is
1 To investigate the prevalence of orofacial pain in HIV infected patients during routine dental clinical assessment
2 To study the sensory phenotype of HIV patients and healthy volunteers using Quantitative Sensory Testing
To detect the presence of sensory aberrations in the orofacial complex
To identify which nerve types are involved
To identify the type of orofacial pain based on both sensory testing and clinical findings
3 To determine psychological condition and nutrition status in patients with HIV
4 To find associations between inherited traits and development of neuropathic pain
The epidemiology of orofacial pain has been reported extensively in the literature yet the prevalence severity and level of pain affecting the head face neck and intraoral structures has not been explored in a population of HIV infected individuals
Pain in general terms is a common experience in HIV infected patients even in the absence of cancer or opportunistic infections There is a variation in the prevalence of pain in these individuals depending on the stage of disease care setting and study methods The purpose of this study is
1 To investigate the prevalence of orofacial pain in HIV infected patients during routine dental clinical assessment
2 To study the sensory phenotype of HIV patients and healthy volunteers using Quantitative Sensory Testing
To detect the presence of sensory aberrations in the orofacial complex
To identify which nerve types are involved
To identify the type of orofacial pain based on both sensory testing and clinical findings
3 To determine psychological condition and nutrition status in patients with HIV
4 To find associations between inherited traits and development of neuropathic pain
Detailed Description:
Patients and control volunteers will be recruited from the Oral medicine Post-graduate clinic at NJDS Medical history will be taken and will include age gender ethnicity current and past illnesses current and past medications blood reports CD4 and CD8 counts which have been obtained during routine medical assessment The clinician will perform a clinical head and neck examination The examination shall include an extra-oral cranial nerve and temporomandibular joint TMJ examination and muscle palpation A thorough intraoral examination will be performed Patients will be examined for pathologies of the oral mucosa teeth and periodontium prior to their participation in the study The evaluation findings will be reported using the Research Diagnostic Criteria for Temperomandibular disorders The patient will note level of pain on Visual Analogue Scale if there is any pre-existing orofacial pain Psychological screening and nutritional questionnaires will be completed by the patient
Quantitative Sensory Testing will be conducted bilaterally on the face and intraorally on the tongue Extraorally the infraorbital and mental nerves regions will be tested bilaterally using thermal and electrical detection thresholds Intraorally the tongue will be tested bilaterally for thermal and electrical detection threshold
Many of the differences among people in the way they respond to symptomatic therapies and their individual risk of HIV patients with neuropathic pain may be affected by their genetic makeup We will search for these kinds of associations between inherited traits and development of neuropathic pain in this study
If the patient presents with evidence for pathologies that requires extraction of any molar based on clinical and radiographic findings the patient will be assessed 3 days 8 days post-extraction and then after 3 weeks for thermal and electrical detection thresholds
Inclusion criteria
Group I n 40 HIV with CD4T cellsmm³ 500 as determined by previous routine medical examination and from previous blood reports
Group II n 40 HIV with CD4T cellsmm³ 200-499 as determined by previous routine medical examination and from previous blood reports
Group III n 40 HIV with CD4T cellsmm³ 200 as determined by previous routine medical examination and from previous blood reports
Control Group n 40 Healthy with normal blood reports without dental pathologies
Quantitative Sensory Testing will be conducted bilaterally on the face and intraorally on the tongue Extraorally the infraorbital and mental nerves regions will be tested bilaterally using thermal and electrical detection thresholds Intraorally the tongue will be tested bilaterally for thermal and electrical detection threshold
Many of the differences among people in the way they respond to symptomatic therapies and their individual risk of HIV patients with neuropathic pain may be affected by their genetic makeup We will search for these kinds of associations between inherited traits and development of neuropathic pain in this study
If the patient presents with evidence for pathologies that requires extraction of any molar based on clinical and radiographic findings the patient will be assessed 3 days 8 days post-extraction and then after 3 weeks for thermal and electrical detection thresholds
Inclusion criteria
Group I n 40 HIV with CD4T cellsmm³ 500 as determined by previous routine medical examination and from previous blood reports
Group II n 40 HIV with CD4T cellsmm³ 200-499 as determined by previous routine medical examination and from previous blood reports
Group III n 40 HIV with CD4T cellsmm³ 200 as determined by previous routine medical examination and from previous blood reports
Control Group n 40 Healthy with normal blood reports without dental pathologies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None