Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-02-25 @ 2:36 AM
Study NCT ID:
NCT03140059
Status:
UNKNOWN
Last Update Posted:
2017-10-18
First Post:
2017-05-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Surgical Access and Repeated Applications of APDT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-05-13', 'releaseDate': '2020-04-30'}], 'estimatedResultsFirstSubmitDate': '2020-04-30'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010520', 'term': 'Aggressive Periodontitis'}], 'ancestors': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-16', 'studyFirstSubmitDate': '2017-05-02', 'studyFirstSubmitQcDate': '2017-05-02', 'lastUpdatePostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical attachment level', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Probing depth', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['surgical procedure', 'residual pockets', 'agressive periodontitis', 'antimicrobial photodynamic therapy'], 'conditions': ['Aggressive Periodontitis, Generalized']}, 'referencesModule': {'references': [{'pmid': '19563331', 'type': 'BACKGROUND', 'citation': 'Lulic M, Leiggener Gorog I, Salvi GE, Ramseier CA, Mattheos N, Lang NP. One-year outcomes of repeated adjunctive photodynamic therapy during periodontal maintenance: a proof-of-principle randomized-controlled clinical trial. J Clin Periodontol. 2009 Aug;36(8):661-6. doi: 10.1111/j.1600-051X.2009.01432.x. Epub 2009 Jun 25.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study will be to compare the approach of repeated applications of APDT versus surgical therapy for the treatment of residual pockets in generalized agressive periodontitis.', 'detailedDescription': 'Scaling and root planing may be insufficient to resolve the periodontal infection resulting in residual periodontal pockets. A method of treatment to these sites would be the surgical therapy, because it allows access to root surfaces, making possible a better decontamination. However, the surgical approach may bring some negative points, as more discomfort and postoperative morbidity, increased transoperatory risk and increased risk of contamination. Thus, finding other alternatives to residual pockets treatment, antimicrobial photodynamic therapy (aPDT) was recently proposed. Therefore, the aim of this study will be to compare the approach of repeated applications of APDT versus surgical therapy for the treatment of residual pockets in generalized agressive periodontitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of generalized aggressive periodontitis (Armitage, 1999; American Academy of Periodontology, 2015);\n* Have undergone a first approach for periodontal treatment (full-mouth ultrasonic debridement);\n* Present at least one residual pocket of probing depth ≥ 5 mm and bleeding on probe not located in furcation region;\n* Good general health;\n* Agree to participate in the study and sign the informed consent form (TCLE) after explaining the risks and benefits;\n\nExclusion Criteria:\n\n* Systemic problems (cardiovascular alterations, blood dyscrasias, immunodeficiency - ASA III / IV / V) that contraindicate the periodontal procedure;\n* Have used antibiotics and anti-inflammatories in the last six months;\n* Smoke ≥ 10 cigarettes/day;\n* Pregnant or lactating;\n* Chronic use of medications that may alter the response of periodontal tissues;\n* Indication of antibiotic prophylaxis for dental procedures;'}, 'identificationModule': {'nctId': 'NCT03140059', 'briefTitle': 'Comparison Between Surgical Access and Repeated Applications of APDT', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Estadual Paulista Júlio de Mesquita Filho'}, 'officialTitle': 'Comparison Between Surgical Access and Repeated Applications of APDT to Residual Pockets Treatment in Generalized Aggressive Periodontitis: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'SurgeryPDT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Open flap debridement', 'description': 'In this group (n = 22), patients will receive open flap debridement will be performed to treat residual pockets.', 'interventionNames': ['Procedure: Open flap debridement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Repeated application of aPDT', 'description': 'In this group (n=22), patients will receive 5 applications of antimicrobial photodynamic therapy after the scaling and root planing.', 'interventionNames': ['Procedure: Repeated application of aPDT']}], 'interventions': [{'name': 'Open flap debridement', 'type': 'PROCEDURE', 'otherNames': ['Surgical therapy'], 'description': 'Open flap debridement will be performed to decontaminate root surface', 'armGroupLabels': ['Open flap debridement']}, {'name': 'Repeated application of aPDT', 'type': 'PROCEDURE', 'description': 'Repeated application of photodynamic therapy (aPDT) at 0, 1, 2, 7 and 14 days post-operatively.', 'armGroupLabels': ['Repeated application of aPDT']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mauro P Santamaria, DDS, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidade Estadual Paulista "Julio de Mesquita Filho", ICT/UNESP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Estadual Paulista Júlio de Mesquita Filho', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS,MS,PhD', 'investigatorFullName': 'Mauro Pedrine Santamaria', 'investigatorAffiliation': 'Universidade Estadual Paulista Júlio de Mesquita Filho'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-04-30', 'type': 'RELEASE'}, {'date': '2020-05-13', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mauro Pedrine Santamaria, DDS,MS,PhD, Universidade Estadual Paulista Júlio de Mesquita Filho'}}}}