Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-01-09 @ 9:35 AM
Study NCT ID:
NCT03262402
Status:
COMPLETED
Last Update Posted:
2020-03-27
First Post:
2017-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Periodontal Treatment on HIV-infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D055113', 'term': 'Chronic Periodontitis'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-25', 'studyFirstSubmitDate': '2017-08-19', 'studyFirstSubmitQcDate': '2017-08-21', 'lastUpdatePostDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in clinical signs of chronic periodontitis.', 'timeFrame': 'Baseline, 30 days and 90 days.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in Candida spp carriage.', 'timeFrame': 'Baseline, 30 days and 90 days.', 'description': 'Number of Candida spp colonies on culture plates.'}, {'measure': 'Change in salivary biomarkers', 'timeFrame': 'Baseline, 30 days and 90 days.', 'description': 'Concentrations of histatin, lactoferrin and inflammatory cytokines in saliva and gingival crevicular fluid in pg/mL.'}, {'measure': 'Change in bacterial microbiota', 'timeFrame': 'Baseline, 30 days and 90 days.', 'description': 'Pyrosequencing characterization of the bacterial microbiota'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic periodontitis', 'Candida spp', 'Histatin-5', 'Lactoferrin'], 'conditions': ['HIV/AIDS', 'Periodontal Diseases']}, 'referencesModule': {'references': [{'pmid': '28591257', 'type': 'BACKGROUND', 'citation': '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': '24720483', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '36 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* For HIV-infected group: CD4 T lymphocytes \\< 200 cel/mm3, stable HAART for the 6 months previous to study enrollment.\n\nExclusion Criteria:\n\n* General for both groups/arms: periodontal treatment and use of antibiotics for the 6 months previous to study enrollment; smoking; complex systemic conditions.'}, 'identificationModule': {'nctId': 'NCT03262402', 'briefTitle': 'Effects of Periodontal Treatment on HIV-infected Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Determination of Factors Involved in the Pathogenesis of Periodontal Diseases in HIV-infected Patients', 'orgStudyIdInfo': {'id': 'CAAE: 50004415.1.0000.5419'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIV-infected group', 'description': '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.', 'interventionNames': ['Procedure: Basic periodontal treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-HIV infected group', 'description': '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.', 'interventionNames': ['Procedure: Basic periodontal treatment']}], 'interventions': [{'name': 'Basic periodontal treatment', 'type': 'PROCEDURE', 'otherNames': ['Non-surgical periodontal treatment'], 'description': 'Basic periodontal treatment consists of scaling and root planing performed with manual curettes or ultrasonic instruments.', 'armGroupLabels': ['HIV-infected group', 'Non-HIV infected group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14040-904', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'School of Dentistry of Ribeirão Preto, University of São Paulo', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}], 'overallOfficials': [{'name': 'Ana Carolina F Motta, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available within 3 months of study completion.', 'ipdSharing': 'YES', 'description': 'Individual participant data of all primary and secondary outcomes will be made available.', 'accessCriteria': 'Data access criteria will be reviewed by the an external independent review panel.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Oral Diagnosis', 'investigatorFullName': 'Ana Carolina Fragoso Motta, DDS, PhD', 'investigatorAffiliation': 'University of Sao Paulo'}}}}