Clinical trial NCT03262402: Effects of Periodontal Treatment on HIV-infected Patients
Official title: Determination of Factors Involved in the Pathogenesis of Periodontal Diseases in HIV-infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Periodontal Diseases
Keywords: Chronic periodontitis
Candida spp
Histatin-5
Lactoferrin
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 22
Sex: ALL
Minimum age (years): 36
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Periodontal diseases, such as chronic periodontitis (CP), frequently occur in immunosuppressed patients, including HIV-infected patients. The immunosuppression resulted by the HIV infection can justify the high frequency and the difficult in controlling the CP in this group of patients, raising the possibility of additional factors associated to the development of CP in HIV patients. The aim of this study is to determine factors that can be involved in the CP pathogenesis in HIV patients, including Candida spp presence, and biomarkers involved on the inflammatory response against the microorganisms.

Detailed description: Investigators will develop one quasi-experimental study in HIV patients (N=15) and non-HIV patients (N=15) presenting CP. Candida spp count and salivary and gingival crevicular fluid concentrations of histatin, lactoferrin, interleukin-1β, interleukin-6, and tumor necrosis factor-α will be determined at baseline, 30 and 90 days after the periodontal treatment. In order to minimize the influence of the immunosuppressive condition, patients have to present CD4 T lymphocytes \< 200cel/mm3 blood count, non-detectable viral load and the same protocol of antiretroviral therapy. Additionally, investigators intend to determine the immunophenotypic profile of the gingival tissue through immunohistochemical analysis. This study was approved by the Institutional Review Board of the School of Dentistry of Ribeirão Preto (CAAE: 50004415.1.0000.5419), and all patients need to provide written informed consent.

Eligibility criteria: Inclusion Criteria:

* General for both groups/arms: Patients with at least 15 teeth; with chronic periodontitis (at least 2 sites with pocket probing depth ≥ 5mm and clinical attachment loss \>4mm); no use of antibiotics for the 6 months previous to study enrolment.
* For HIV-infected group: CD4 T lymphocytes \< 200 cel/mm3, stable HAART for the 6 months previous to study enrollment.

Exclusion Criteria:

* General for both groups/arms: periodontal treatment and use of antibiotics for the 6 months previous to study enrollment; smoking; complex systemic conditions.

Primary outcomes:
measure: Change in clinical signs of chronic periodontitis.
timeFrame: Baseline, 30 days and 90 days.
Secondary outcomes:
measure: Change in Candida spp carriage.
timeFrame: Baseline, 30 days and 90 days.
measure: Change in salivary biomarkers
timeFrame: Baseline, 30 days and 90 days.
measure: Change in bacterial microbiota
timeFrame: Baseline, 30 days and 90 days.
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: School of Dentistry of Ribeirão Preto, University of São Paulo
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Ana Carolina F Motta, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lourenco AG, Ribeiro AERA, Nakao C, Motta ACF, Antonio LGL, Machado AA, Komesu MC. Oral Candida spp carriage and periodontal diseases in HIV-infected patients in Ribeirao Preto, Brazil. Rev Inst Med Trop Sao Paulo. 2017 Jun 1;59:e29. doi: 10.1590/S1678-9946201759029.
citation: Lourenco AG, Rodrigues Alves Ribeiro AE, Nakao C, Fragoso Motta AC, Machado AA, Komesu MC. Influence of antiretroviral therapy and periodontal disease on human salivary beta-defensin 2 in patients infected with HIV. Curr HIV Res. 2014;12(1):44-9. doi: 10.2174/1570162x12666140407125120.