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Effects of Periodontal Treatment on HIV-infected Patients

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ClinicalTrials.gov Identifier: NCT03262402
Recruitment Status : Active, not recruiting
First Posted : August 25, 2017
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Ana Carolina Fragoso Motta, DDS, PhD, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Periodontal Diseases Procedure: Basic periodontal treatment Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Determination of Factors Involved in the Pathogenesis of Periodontal Diseases in HIV-infected Patients
Actual Study Start Date : July 2, 2017
Actual Primary Completion Date : August 2, 2018
Estimated Study Completion Date : April 8, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HIV-infected group
Patients will be treated for their chronic periodontitis (basic periodontal treatment) and samples of gingival crevicular fluid and saliva will be collected at baseline, 30 days and 60 days after the periodontal treatment for the study analysis.
Procedure: Basic periodontal treatment
Basic periodontal treatment consists of scaling and root planing performed with manual curettes or ultrasonic instruments.
Other Name: Non-surgical periodontal treatment

Active Comparator: Non-HIV infected group
Patients will be treated for their chronic periodontitis (basic periodontal treatment) and samples of gingival crevicular fluid and saliva will be collected at baseline, 30 days and 60 days after the periodontal treatment for the study analysis.
Procedure: Basic periodontal treatment
Basic periodontal treatment consists of scaling and root planing performed with manual curettes or ultrasonic instruments.
Other Name: Non-surgical periodontal treatment




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   36 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03262402


Locations
Brazil
School of Dentistry of Ribeirão Preto, University of São Paulo
Ribeirão Preto, São Paulo, Brazil, 14040-904
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Ana Carolina F Motta, DDS, PhD University of São Paulo

Publications:
Responsible Party: Ana Carolina Fragoso Motta, DDS, PhD, Professor of Oral Diagnosis, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03262402     History of Changes
Other Study ID Numbers: CAAE: 50004415.1.0000.5419
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data of all primary and secondary outcomes will be made available.
Supporting Materials: Study Protocol
Time Frame: Data will be available within 3 months of study completion.
Access Criteria: Data access criteria will be reviewed by the an external independent review panel.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ana Carolina Fragoso Motta, DDS, PhD, University of Sao Paulo:
Chronic periodontitis
Candida spp
Histatin-5
Lactoferrin

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Mouth Diseases
Stomatognathic Diseases