Effects of Periodontal Treatment on HIV-infected Patients

NCT03262402 | Completed DMC

• 1 other identifier: CAAE: 50004415.1.0000.5419
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS; Periodontal Diseases

Keywords

Chronic periodontitis; Candida spp; Histatin-5; Lactoferrin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Candida spp carriage.

  Baseline, 30 days and 90 days.

• Change in salivary biomarkers

  Baseline, 30 days and 90 days.

• Change in bacterial microbiota

  Baseline, 30 days and 90 days.

Study Arms (2)

HIV-infected group

EXPERIMENTAL

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

Non-HIV infected group

ACTIVE COMPARATOR

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

Interventions

Basic periodontal treatment PROCEDURE

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

Also known as: Non-surgical periodontal treatment

HIV-infected group; Non-HIV infected group

Eligibility Criteria

• Age: 36 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• General for both groups/arms: periodontal treatment and use of antibiotics for the 6 months previous to study enrollment; smoking; complex systemic conditions.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

School of Dentistry of Ribeirão Preto, University of São Paulo

Ribeirão Preto, São Paulo, 14040-904, Brazil

Location

Related Publications (2)

• Lourenco 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 Ribeirao Preto, Brazil. Rev Inst Med Trop Sao Paulo. 2017 Jun 1;59:e29. doi: 10.1590/S1678-9946201759029.

  PMID: 28591257 BACKGROUND

• 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. doi: 10.2174/1570162x12666140407125120.

  PMID: 24720483 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Periodontal Diseases; Chronic Periodontitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Ana Carolina F Motta, DDS, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Oral Diagnosis

Study Record Dates

• First Submitted: August 19, 2017
• First Posted: August 25, 2017
• Study Start: July 2, 2017
• Primary Completion: August 2, 2018
• Study Completion: April 8, 2019
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

BR (1)