Trials / Completed
CompletedNCT03262402
Effects of Periodontal Treatment on HIV-infected Patients
Determination of Factors Involved in the Pathogenesis of Periodontal Diseases in HIV-infected Patients
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- University of Sao Paulo · Academic / Other
- Sex
- All
- Age
- 36 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Basic periodontal treatment | Basic periodontal treatment consists of scaling and root planing performed with manual curettes or ultrasonic instruments. |
Timeline
- Start date
- 2017-07-02
- Primary completion
- 2018-08-02
- Completion
- 2019-04-08
- First posted
- 2017-08-25
- Last updated
- 2020-03-27
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT03262402. Inclusion in this directory is not an endorsement.