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Completed

NCT Number: NCT03262402

Effects of Periodontal Treatment on HIV-infected Patients

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Chronic Disease Chronic Periodontitis Communicable Diseases Disease Attributes Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Stomatognathic Diseases Urogenital Diseases Virus Diseases

Age range

36 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry of Ribeirão Preto, University of São Paulo

Ribeirão Preto, São Paulo, 14040-904, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Basic periodontal treatment

Procedure

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

Other names: Non-surgical periodontal treatment

Primary outcomes

  1. Change in clinical signs of chronic periodontitis.

    Time frame: 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 outcomes

  1. Change in Candida spp carriage.

    Time frame: Baseline, 30 days and 90 days.

    Number of Candida spp colonies on culture plates.

  2. Change in salivary biomarkers

    Time frame: Baseline, 30 days and 90 days.

    Concentrations of histatin, lactoferrin and inflammatory cytokines in saliva and gingival crevicular fluid in pg/mL.

  3. Change in bacterial microbiota

    Time frame: Baseline, 30 days and 90 days.

    Pyrosequencing characterization of the bacterial microbiota

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 25, 2017
Registry last updated
Mar 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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