Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-03-11 @ 9:13 PM
Study NCT ID:
NCT03462368
Status:
COMPLETED
Last Update Posted:
2023-02-27
First Post:
2018-02-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Root Coverage by Connective Graft and Different Root Conditioning Adjunctive Therapies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005889', 'term': 'Gingival Recession'}], 'ancestors': [{'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014080', 'term': 'Tooth Exfoliation'}, {'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2019-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-24', 'studyFirstSubmitDate': '2018-02-28', 'studyFirstSubmitQcDate': '2018-03-08', 'lastUpdatePostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total root coverage', 'timeFrame': 'One year', 'description': 'Total root coverage measured with a periodontal probe in millimeters. Ideal if the distance from cemento-enamel junction to gingival margin = 0 mm'}], 'secondaryOutcomes': [{'measure': 'Keratinized mucosa width', 'timeFrame': 'One year', 'description': 'Keratinized mucosa width is measured with a periodontal probe in mm, from gingival margin to mucogingival junction. Ideal if keratinized mucosa width \\> 5mm'}, {'measure': 'Probing depth', 'timeFrame': 'One year', 'description': 'Probing depth measured with a periodontal probe in millimeters. The distance from gingival margin and the apical point of gingival pocket or sulcus. Ideal if \\<2mm.'}, {'measure': 'Clinical attachment level', 'timeFrame': 'One year', 'description': 'Clinical attachment level measured with a periodontal probe in millimeters. The distance from cemento-enamel junction and the apical point of gingival pocket or sulcus. Ideal if \\<2mm.'}, {'measure': 'Dentin hypersensitivity', 'timeFrame': 'One year', 'description': 'Dentin hypersensitivity measured by applying an air jet on teeth and patient fills up a visual analogue scale. Ideal if = 0.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingival Recession', 'Gingival Recession, Generalized']}, 'referencesModule': {'references': [{'pmid': '26095265', 'type': 'BACKGROUND', 'citation': "Karam PS, Sant'Ana AC, de Rezende ML, Greghi SL, Damante CA, Zangrando MS. Root surface modifiers and subepithelial connective tissue graft for treatment of gingival recessions: a systematic review. J Periodontal Res. 2016 Apr;51(2):175-85. doi: 10.1111/jre.12296. Epub 2015 Jun 11."}, {'pmid': '25363203', 'type': 'BACKGROUND', 'citation': 'Fernandes-Dias SB, de Marco AC, Santamaria M Jr, Kerbauy WD, Jardini MA, Santamaria MP. Connective tissue graft associated or not with low laser therapy to treat gingival recession: randomized clinical trial. J Clin Periodontol. 2015 Jan;42(1):54-61. doi: 10.1111/jcpe.12328. Epub 2014 Dec 17.'}, {'pmid': '25844681', 'type': 'BACKGROUND', 'citation': 'Anders JJ, Lanzafame RJ, Arany PR. Low-level light/laser therapy versus photobiomodulation therapy. Photomed Laser Surg. 2015 Apr;33(4):183-4. doi: 10.1089/pho.2015.9848. No abstract available.'}, {'pmid': '40227516', 'type': 'DERIVED', 'citation': "Cardoso MV, Sant'Ana ACP, Zangrando MSR, Damante CA. Effects of photobiostimulation and antimicrobial photodynamic therapy associated with gingival grafts for root coverage: three-arm randomized clinical trial. Lasers Med Sci. 2025 Apr 14;40(1):190. doi: 10.1007/s10103-025-04449-0."}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the effect of two different treatment agents used in conjunction with subepithelial connective graft technique on root coverage outcomes in multiple recession defects. Half of patients will receive root treatment with antimicrobial photodynamic therapy and the other half will receive photobiomodulation therapy by laser on surgery site.', 'detailedDescription': 'Antimicrobial photodynamic therapy has been widely used in Periodontics to obtain reduction of periodontopathogenic bacteria with absence of systemic side effects and minimal bacterial resistance. Also, it has properties of root demineralization and exposure of collagen fibers. These properties may enhance root coverage in procedures of subepithelial connective graft. Laser photobiomodulation has the potential to increase healing and repair, this can generate gains in the root coverage and dental hypersensitivity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Multiple Gingival recession - two or more Miller's class I or II (2 to 5 mm of height)\n* Indication of root coverage by dentin hypersensitivity or esthetic.\n* Minimum palate thickness (1,5mm)\n* Visible Enamel cement junction (JCE) on the teeth to be treated and pulp vitality\n* Patients without signs of periodontal disease activity and with plaque index and bleeding on probing throughout ≤20%;\n\nExclusion Criteria:\n\n* Use of drugs that affect periodontal tissues (eg: anticonvulsants, calcium channel blockers, cyclosporine, bisphosphonates, hormone-based contraceptives, steroids)\n* Smokers\n* Pregnancy\n* Diabetics\n* History of head and neck radiotherapy\n* Teeth with mobility\n* Malpositioned teeth\n* History of periodontal surgery at the area on the last 12 months\n* Patients with orthodontic therapy in progression"}, 'identificationModule': {'nctId': 'NCT03462368', 'briefTitle': 'Evaluation of Root Coverage by Connective Graft and Different Root Conditioning Adjunctive Therapies', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Effects of Photobiomodulation and Antimicrobial Photodynamic Therapy Associated With Subepithelial Connective Tissue Graft on the Root Coverage of Multiple Gingival Recessions: A Randomized Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': 'FOBaPDTrecession'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Root surface treatment by scaling and root planing', 'interventionNames': ['Procedure: Control']}, {'type': 'EXPERIMENTAL', 'label': 'antimicrobial photodynamic therapy', 'description': 'Root surface treatment by antimicrobial photodynamic therapy', 'interventionNames': ['Procedure: antimicrobial photodynamic therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Photobiomodulation', 'description': 'Treatment of the whole surgical site with laser', 'interventionNames': ['Procedure: Photobiomodulation']}], 'interventions': [{'name': 'Control', 'type': 'PROCEDURE', 'otherNames': ['Scaling and root planing only'], 'description': 'In the procedure of subepithelial connective tissue graft, exposed dental roots will be treated by scaling and root planing only.', 'armGroupLabels': ['Control']}, {'name': 'antimicrobial photodynamic therapy', 'type': 'PROCEDURE', 'description': 'In the procedure of subepithelial connective tissue graft, exposed dental roots will be treated by antimicrobial photodynamic therapy with toluidine blue O (10mg/ml)', 'armGroupLabels': ['antimicrobial photodynamic therapy']}, {'name': 'Photobiomodulation', 'type': 'PROCEDURE', 'otherNames': ['Low level laser therapy'], 'description': 'After the procedure of subepithelial connective tissue graft the whole surgical site will receive red laser application.', 'armGroupLabels': ['Photobiomodulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17012-901', 'city': 'Bauru', 'state': 'São Paulo', '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'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Carla Andreotti Damante', 'investigatorAffiliation': 'University of Sao Paulo'}}}}