Effects of Periodontal Treatment on HIV-infected Patients

HIV/AIDS Clinical Trial

Official title:

Determination of Factors Involved in the Pathogenesis of Periodontal Diseases in HIV-infected Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03262402
• Other study ID #: CAAE: 50004415.1.0000.5419
• Status: Completed
• Phase: N/A
• Start date: July 2, 2017
• Est. completion date: April 8, 2019

Study information

• Verified date: March 2020
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 8, 2019
• Est. primary completion date: August 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 36 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV/AIDS
• Periodontal Diseases

Intervention

Procedure:
• Basic periodontal treatment
Basic periodontal treatment consists of scaling and root planing performed with manual curettes or ultrasonic instruments.

Locations

Country	Name	City	State
Brazil	School of Dentistry of Ribeirão Preto, University of São Paulo	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Lourenço 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 Ribeirão Preto, Brazil. Rev Inst Med Trop Sao Paulo. 2017 Jun 1;59:e29. doi: 10.1590/S1678-9946201759029. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in clinical signs of chronic periodontitis.	Clinical parameters of the periodontal diseases: Dental biofilm index and bleeding on probing (BOP) measured in percentage associated to pocket probing depth (PPD) and clinical attachment loss (CAL) measured in millimeters will be combined to report the effect of periodontal treatment on the chronic periodontitis in percentage of sites with no periodontal diseases signs.	Baseline, 30 days and 90 days.
Secondary	Change in Candida spp carriage.	Number of Candida spp colonies on culture plates.	Baseline, 30 days and 90 days.
Secondary	Change in salivary biomarkers	Concentrations of histatin, lactoferrin and inflammatory cytokines in saliva and gingival crevicular fluid in pg/mL.	Baseline, 30 days and 90 days.
Secondary	Change in bacterial microbiota	Pyrosequencing characterization of the bacterial microbiota	Baseline, 30 days and 90 days.