Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-02-20 @ 3:39 PM
Study NCT ID:
NCT03200392
Status:
COMPLETED
Last Update Posted:
2020-07-22
First Post:
2017-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Er,Cr:YSGG Laser For Recipient Bed Bio-modification And Connective Tissue Harvesting in Treatment of Gingival Recession
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Masking of investigator and participants was not applicable due to surgical procedure and use of laser either for root surface bio-modification or during connective tissue harvesting. The blinded outcome assessor performed the clinical measurements at each selected defect site during the study period. She was not involved in any other part of the study protocol.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-20', 'studyFirstSubmitDate': '2017-06-20', 'studyFirstSubmitQcDate': '2017-06-26', 'lastUpdatePostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Recession depth', 'timeFrame': 'baseline-3-6-9 months', 'description': "measured from the gingival margin to the cemento-enamel junction at the mid-buccal aspect of the tooth using William's graduated periodontal probe to the nearest mm"}], 'secondaryOutcomes': [{'measure': 'Pain assessment at the donor site', 'timeFrame': '7 days', 'description': 'Visual Analogue Scale'}, {'measure': 'number of analgesic pills consumed per day', 'timeFrame': '7 days', 'description': 'counting number of analgesic pills per day'}, {'measure': 'Recession width', 'timeFrame': 'baseline-3-6-9 months', 'description': 'distance between mesial and distal gingival margin of the tooth recorded on a horizontal line tangential at the CEJ to the nearest mm'}, {'measure': 'Gingival thickness', 'timeFrame': 'baseline and at 9 months', 'description': 'determined 2mm apical to the gingival margin using standardised CBCT'}, {'measure': 'Height of keratinized tissue width', 'timeFrame': 'baseline and at 9 months', 'description': 'measured form the mid-buccal aspect of the gingival margin to the mucogingival line'}, {'measure': 'Clinical attachment loss', 'timeFrame': 'baseline-3-6-9 months', 'description': 'measured from the CEJ to the bottom of the periodontal pocket to the nearest mm.'}, {'measure': 'Probing pocket depth', 'timeFrame': 'baseline-3-6-9 months', 'description': 'measured from the gingival margin to the base of the periodontal pocket to the nearest mm'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Er,Cr:YSGG laser', 'connective tissue graft', 'root coverage', 'mucogingival surgery', 'gingival recession'], 'conditions': ['Gingival Recession, Localized']}, 'referencesModule': {'references': [{'pmid': '26660000', 'type': 'BACKGROUND', 'citation': 'Ozcelik O, Seydaoglu G, Haytac CM. Diode laser for harvesting de-epithelialized palatal graft in the treatment of gingival recession defects: a randomized clinical trial. J Clin Periodontol. 2016 Jan;43(1):63-71. doi: 10.1111/jcpe.12487. Epub 2016 Jan 21.'}]}, 'descriptionModule': {'briefSummary': 'A clinical and radiographic evaluation of using Erbium, Chromium, Scandium, Gallium and Garnet (Er,Cr:YSGG) laser in recipient site bio-modification and de-epithelialized connective tissue graft harvesting compared to conventional scalpel surgical technique in the treatment of class I and II Miller gingival recession.', 'detailedDescription': 'Twenty four patients suffering from isolated Class I and II Miller gingival recession defects in anterior esthetic region were enrolled in this study. They were randomly assigned into three groups; de-epithelialized connective tissue graft harvesting technique or; conditioning the exposed root surfaces with Er,Cr:YSGG laser before connective tissue coverage using scalpel blade harvested de-epithelialized connective tissue graft harvesting technique, or; conditioning the exposed root surfaces with the Er,Cr:YSGG laser before Er,Cr:YSGG laser harvested connective tissue using de-epithelialized technique. Clinical and radiographic parameters were recorded at baseline and at 3, 6 and 9 months postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '58 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Single class I, II Miller gingival recession defects (≥ 2mm in depth), presence of identifiable buccal cemento-enamel junction (CEJ) and presence of a step ≤ 1 mm at CEJ.\n2. Controlled periodontal disease\n3. Full-mouth plaque score of \\<10%; full-mouth gingival score of \\<15%\n4. Patients available for 9 months follow-up period.\n\nExclusion Criteria:\n\n1. Smokers.\n2. Pregnant and lactating females.\n3. Taking medications known to interfere with periodontal tissue health or healing.\n4. Previous periodontal surgery on the involved sites.\n5. Non-vital teeth.\n6. Molar teeth.\n7. Recession defects associated with caries or restoration.\n8. Occlusal interferences.\n9. Taking anti-inflammatory drugs or antibiotics in the past 6 months.'}, 'identificationModule': {'nctId': 'NCT03200392', 'briefTitle': 'Er,Cr:YSGG Laser For Recipient Bed Bio-modification And Connective Tissue Harvesting in Treatment of Gingival Recession', 'organization': {'class': 'OTHER', 'fullName': 'Misr International University'}, 'officialTitle': 'The Use Of Er,Cr:YSGG Laser For Recipient Bed Bio-modification And De-epithelialized Palatal Graft Harvesting In The Treatment of Gingival Recession Defects -(Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': '121409'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'L-DGG/LRB', 'description': 'laser root surface conditioning \\& laser DGG harvesting', 'interventionNames': ['Device: laser root surface conditioning & laser DGG harvesting']}, {'type': 'EXPERIMENTAL', 'label': 'B-DGG/LRB', 'description': 'laser root surface conditioning \\& blade DGG harvesting', 'interventionNames': ['Device: laser root surface conditioning & blade DGG harvesting']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B-DGG', 'description': 'blade DGG harvesting', 'interventionNames': ['Procedure: blade DGG harvesting']}], 'interventions': [{'name': 'laser root surface conditioning & laser DGG harvesting', 'type': 'DEVICE', 'otherNames': ['erbium, chromium:YSGG laser'], 'description': "laser root surface bio-modification (single application) and placement of harvested de-epithelialized gingival graft (DGG) followed by coronal repositioned flap for gingival recession Miller's I, II defect coverage", 'armGroupLabels': ['L-DGG/LRB']}, {'name': 'laser root surface conditioning & blade DGG harvesting', 'type': 'DEVICE', 'otherNames': ['erbium, chromium:YSGG laser'], 'description': "laser root surface bio-modification (single application) and scalpel blade harvesting of de-epithelialized palatal graft (Zucchelli et al. 2010) and coronal repositioned flap for gingival recession Miller's I, II defect coverage", 'armGroupLabels': ['B-DGG/LRB']}, {'name': 'blade DGG harvesting', 'type': 'PROCEDURE', 'description': 'De-epithelialized palatal graft harvested using scalpel blade (Zucchelli et al. 2010) and coronal repositioned flap for gingival recession defect coverage', 'armGroupLabels': ['B-DGG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11218', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Misr International university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ahmed Y Gamal, pHD', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor Department of Periodontology Ain Shams University'}, {'name': 'Tarek M Eltayeb, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Doctor student Department of Periodontology Misr International University (MIU)'}, {'name': 'Shahinaz G Elashiry, pHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Associate Professor Department of Periodontology MIU'}, {'name': 'Ramy M Ghali, pHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor Department of Prosthodontics Ain Shams University'}, {'name': 'Fatma H Eldemerdash, pHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lecturer Department of Periodontology Ain Shams University'}, {'name': 'Islam S Shaker, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Doctor student Department of Oral Radiology MIU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Misr International University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ain Shams University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'laser certified from Aachen University (Germany) and Assistant Lecturer of Periodontology, Oral Medicine and Oral Diagnosis', 'investigatorFullName': 'Tarek Mahmoud Nasser Eltayeb', 'investigatorAffiliation': 'Misr International University'}}}}