Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-02-20 @ 8:08 PM
Study NCT ID:
NCT03320135
Status:
COMPLETED
Last Update Posted:
2019-06-05
First Post:
2017-10-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EMD for Treatment of Proximal Class-II Furcation Involvements
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-03', 'studyFirstSubmitDate': '2017-10-20', 'studyFirstSubmitQcDate': '2017-10-20', 'lastUpdatePostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Horizontal clinical attachment level', 'timeFrame': '1 year', 'description': 'horizontal component of the defect'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['enamel matrix derivative', 'proximal furcation', 'randomized clinical trial'], 'conditions': ['Generalized Aggressive Periodontitis']}, 'referencesModule': {'references': [{'pmid': '18341602', 'type': 'RESULT', 'citation': 'Casarin RC, Del Peloso Ribeiro E, Nociti FH Jr, Sallum AW, Sallum EA, Ambrosano GM, Casati MZ. A double-blind randomized clinical evaluation of enamel matrix derivative proteins for the treatment of proximal class-II furcation involvements. J Clin Periodontol. 2008 May;35(5):429-37. doi: 10.1111/j.1600-051X.2008.01202.x. Epub 2008 Mar 12.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to evaluate the clinical response of proximal furcations treated with enamel matrix derivative proteins (EMD).', 'detailedDescription': "Proximal class-II furcation represents a challeng to periodontal therapy. Studies show that the ultrasonic non-surgical therapy doesn't work in these defects and the guided tissue regeneration therapy with membranes also demonstrates an unpredictable improvement. Therefore, enamel matrix derivative proteins (EMD) have been proposed as a periodontal regenerative procedure due to their fundamental role in cementum development."}, '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* Presence of one proximal class-II furcation presenting probing depth \\> 4 mm and bleeding on probing ;\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': 'NCT03320135', 'acronym': 'OFD', 'briefTitle': 'EMD for Treatment of Proximal Class-II Furcation Involvements', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Estadual Paulista Júlio de Mesquita Filho'}, 'officialTitle': 'Enamel Matriz Derivate for Treatment of Proximal Class II Furcation Defects: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'UEPJMF ICT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Enamel matrix derivative proteins', 'description': 'Open flap debridement to enamel matrix derivative application in proximal class-II furcation.', 'interventionNames': ['Procedure: Enamel matrix derivative proteins', 'Procedure: Open Flap debridement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Open Flap Debridement', 'description': 'Open flap debridement in proximal class-II furcation.', 'interventionNames': ['Procedure: Open Flap debridement']}], 'interventions': [{'name': 'Enamel matrix derivative proteins', 'type': 'PROCEDURE', 'otherNames': ['Surgical therapy'], 'description': 'Open flap debridement to enamel matrix derivative to treat proximal furcation involvements.', 'armGroupLabels': ['Enamel matrix derivative proteins']}, {'name': 'Open Flap debridement', 'type': 'PROCEDURE', 'otherNames': ['Surgical therapy'], 'description': 'Open flap debridement will be performed to decontaminate the proximal furcation involvements.', 'armGroupLabels': ['Enamel matrix derivative proteins', 'Open Flap Debridement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12245010', 'city': 'São José dos Campos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Naira Andere', 'geoPoint': {'lat': -23.17944, 'lon': -45.88694}}], 'overallOfficials': [{'name': 'Mauro M Santamaria, DDS, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidade Estadual Paulista "Julio de Mesquita Filho", ICT/UNESP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': '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'}}}}