Pain and Sensory Changes Assessment in HIV+ Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

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.
    

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 CD4+T cells/mm³ > 500 as determined by previous routine medical
      examination and from previous blood reports.

      Group II n = 40 HIV+ with CD4+T cells/mm³ 200-499 as determined by previous routine medical
      examination and from previous blood reports.

      Group III n = 40 HIV+ with CD4+T cells/mm³ < 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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV +ve subjects Healthy Controls
      
Biospecimen description: 
      Saliva Samples
    
Keywords: HIV; Quantitative Sensory Testing; Neuropathy; Treatment Experienced; Treatment Naive