Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT03264118
Status:
COMPLETED
Last Update Posted:
2023-02-27
First Post:
2017-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Antimicrobial Photodynamic Therapy on Regeneration of Class II Furcation Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055113', 'term': 'Chronic Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D016301', 'term': 'Alveolar Bone Loss'}], 'ancestors': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001862', 'term': 'Bone Resorption'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014080', 'term': 'Tooth Exfoliation'}, {'id': 'D016745', 'term': 'Root Planing'}, {'id': 'D014048', 'term': 'Tolonium Chloride'}], 'ancestors': [{'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'id': 'D012534', 'term': 'Dental Scaling'}, {'id': 'D003777', 'term': 'Dental Prophylaxis'}, {'id': 'D010517', 'term': 'Periodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D013357', 'term': 'Subgingival Curettage'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}, {'id': 'D010640', 'term': 'Phenothiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Split-mouth design. One side of mouth is test and the other is control side.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2018-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-24', 'studyFirstSubmitDate': '2017-08-24', 'studyFirstSubmitQcDate': '2017-08-25', 'lastUpdatePostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Horizontal probing depth', 'timeFrame': 'one year', 'description': 'Measured with a periodontal probe (mm). Ideal if 0.'}, {'measure': 'Tomographic Bone filling', 'timeFrame': 'One year', 'description': 'Complete filling of furcation defect in tomographic images. Ideal is a radiopaque image similar to neighbor bone.'}], 'secondaryOutcomes': [{'measure': 'Probing depth', 'timeFrame': 'one year', 'description': 'Distance from gingival margin to bottom of sulcus. Measured with a periodontal probe (mm). Ideal if \\< 2 mm.'}, {'measure': 'Clinical Attachment Level', 'timeFrame': 'one year', 'description': 'Distance from cemento-enamel junction to bottom of sulcus. Measured with a periodontal probe (mm). Ideal if \\< 2 mm.'}, {'measure': 'Bleeding on probing', 'timeFrame': 'One year', 'description': 'Visual confirmation of bleeding after probing. Ideal if not bleeding.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Periodontal Guided Tissue Regeneration', 'Photochemotherapy'], 'conditions': ['Periodontitis, Chronic', 'Periodontal Diseases', 'Periodontal Bone Loss']}, 'referencesModule': {'references': [{'pmid': '23731242', 'type': 'BACKGROUND', 'citation': 'Luchesi VH, Pimentel SP, Kolbe MF, Ribeiro FV, Casarin RC, Nociti FH Jr, Sallum EA, Casati MZ. Photodynamic therapy in the treatment of class II furcation: a randomized controlled clinical trial. J Clin Periodontol. 2013 Aug;40(8):781-8. doi: 10.1111/jcpe.12121. Epub 2013 Jun 3.'}, {'pmid': '25644295', 'type': 'BACKGROUND', 'citation': 'Avila-Ortiz G, De Buitrago JG, Reddy MS. Periodontal regeneration - furcation defects: a systematic review from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S108-30. doi: 10.1902/jop.2015.130677.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the additional effect of antimicrobial photodynamic therapy regeneration treatment of mandibular furcation lesions when associated to bovine bone and porcine collagen membrane.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of class II furcation lesion in mandibular 1st and 2nd molars\n* Mandibular 1st and 2nd molars without caries, erosion or abrasion\n\nExclusion Criteria:\n\n* Smoking habit\n* Pregnancy\n* Use of antibiotics in the last six months\n* Periodontal treatment in the last six months\n* Endodontic lesion\n* Systemic diseases that impair wound healing'}, 'identificationModule': {'nctId': 'NCT03264118', 'briefTitle': 'Effects of Antimicrobial Photodynamic Therapy on Regeneration of Class II Furcation Lesions', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Effects of Antimicrobial Photodynamic Therapy Associated to Biomaterials on Regeneration of Class II Furcation Lesions', 'orgStudyIdInfo': {'id': 'BauruSchoolDentistryfurcation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Decontamination of furcation defect with scaling and root planing only.', 'interventionNames': ['Procedure: Scaling and root planing']}, {'type': 'EXPERIMENTAL', 'label': 'Antimicrobial Photodynamic Therapy', 'description': 'Decontamination of furcation defect with scaling and root planing complemented by antimicrobial photodynamic therapy.', 'interventionNames': ['Procedure: Scaling and root planing', 'Drug: Toluidine Blue O']}], 'interventions': [{'name': 'Scaling and root planing', 'type': 'PROCEDURE', 'description': 'Furcation treatment by scaling and root planing', 'armGroupLabels': ['Antimicrobial Photodynamic Therapy', 'Control']}, {'name': 'Toluidine Blue O', 'type': 'DRUG', 'otherNames': ['Antimicrobial photodynamic therapy'], 'description': 'Antimicrobial photodynamic therapy with toluidine blue O (10mg/ml) and red laser.', 'armGroupLabels': ['Antimicrobial Photodynamic Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17012-901', 'city': 'Bauru', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Bauru School of Dentistry', 'geoPoint': {'lat': -22.31472, 'lon': -49.06056}}, {'city': 'Bauru', 'country': 'Brazil', 'facility': 'Bauru School of Dentistry', 'geoPoint': {'lat': -22.31472, 'lon': -49.06056}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Geistlich Pharma AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Carla Andreotti Damante', 'investigatorAffiliation': 'University of Sao Paulo'}}}}