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Effects of Periodontal Treatment on HIV-infected Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03262402
Enrollment
22
Registered
2017-08-25
Start date
2017-07-02
Completion date
2019-04-08
Last updated
2020-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS, Periodontal Diseases

Keywords

Chronic periodontitis, Candida spp, Histatin-5, Lactoferrin

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.

Interventions

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

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
36 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in clinical signs of chronic periodontitis.Baseline, 30 days and 90 days.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.

Secondary

MeasureTime frameDescription
Change in Candida spp carriage.Baseline, 30 days and 90 days.Number of Candida spp colonies on culture plates.
Change in salivary biomarkersBaseline, 30 days and 90 days.Concentrations of histatin, lactoferrin and inflammatory cytokines in saliva and gingival crevicular fluid in pg/mL.
Change in bacterial microbiotaBaseline, 30 days and 90 days.Pyrosequencing characterization of the bacterial microbiota

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026