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Pain and Sensory Changes Assessment in HIV+ Patients, A Model for Pain and Sensory Changes Related Compromised Immune System.


N/A
18 Years
N/A
Not Enrolling
Both
HIV Infections

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Trial Information

Pain and Sensory Changes Assessment in HIV+ Patients, A Model for Pain and Sensory Changes Related Compromised Immune System.


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.


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.

Exclusion Criteria:

- Patients under 18 year of age.

- Pregnant women.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Principal Investigator

Eli Eliav, DMD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Medicine and Dentistry New Jersey

Authority:

United States: Institutional Review Board

Study ID:

0120060172

NCT ID:

NCT00422695

Start Date:

January 2007

Completion Date:

May 2008

Related Keywords:

  • HIV Infections
  • HIV
  • Quantitative Sensory Testing
  • Neuropathy
  • Treatment Experienced
  • Treatment Naive
  • HIV Infections
  • Acquired Immunodeficiency Syndrome

Name

Location

New Jersey Dental SchoolNewark, New Jersey  07101