Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-01-01 @ 7:22 AM
Study NCT ID:
NCT07064304
Status:
COMPLETED
Last Update Posted:
2025-07-14
First Post:
2025-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Er,Cr:YSGG Laser for Deepithelialization in 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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-10', 'studyFirstSubmitDate': '2025-06-30', 'studyFirstSubmitQcDate': '2025-07-10', 'lastUpdatePostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Recession Depth', 'timeFrame': 'Baseline, 3 months, and 6 months postoperatively', 'description': 'Measurement of gingival recession depth in millimeters to evaluate soft tissue response to treatment.\n\nUnit of Measure: mm'}, {'measure': 'Change in Keratinized Tissue Width', 'timeFrame': 'Baseline, 3 months, and 6 months postoperatively', 'description': 'Measurement of the width of keratinized gingiva in millimeters from the mucogingival junction to the free gingival margin.\n\nUnit of Measure: mm'}, {'measure': 'Change in Gingival Thickness', 'timeFrame': 'Baseline, 3 months, and 6 months postoperatively', 'description': 'Assessment of gingival tissue thickness using a standardized probe. Unit of Measure: mm'}, {'measure': 'Change in Pocket Depth', 'timeFrame': 'Baseline, 3 months, and 6 months postoperatively', 'description': 'Probing depth measured from the gingival margin to the base of the periodontal pocket.\n\nUnit of Measure: mm'}, {'measure': 'Change in Clinical Attachment Level', 'timeFrame': 'Baseline, 3 months, and 6 months postoperatively', 'description': 'Measurement of the distance from the cementoenamel junction to the base of the periodontal pocket.\n\nUnit of Measure: mm'}, {'measure': 'Change in Pink Esthetic Score', 'timeFrame': 'Baseline, 3 months, and 6 months postoperatively', 'description': 'Percentage of interdental spaces with visible plaque, calculated to assess oral hygiene status. A lower percentage indicates better plaque control.\n\nUnit of Measure: percentage (%)'}, {'measure': 'Mean Root Coverage', 'timeFrame': '6 months postoperatively', 'description': 'Average percentage of root surface covered by soft tissue following treatment, calculated across all treated sites.\n\nUnit of Measure: percentage (%)'}, {'measure': 'Complete Root Coverage', 'timeFrame': '6 months postoperatively', 'description': 'Proportion of treated sites that achieved 100% root coverage postoperatively. Unit of Measure: percentage (%)'}], 'secondaryOutcomes': [{'measure': 'Histopathological Evaluation of Laser-Treated Connective Tissue Grafts', 'timeFrame': 'Immediately postoperatively', 'description': 'Microscopic assessment of grafts treated with Er,Cr:YSGG laser to evaluate the quality of deepithelialization and potential thermal damage. Parameters included the presence of a clear boundary between epithelium and connective tissue, absence of carbonization or necrosis, and preservation of tissue architecture.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingival Recession, Localized', 'Keratinized Tissue', 'Gingival Thickness', 'Pocket Depth']}, 'descriptionModule': {'briefSummary': 'Abstract: Introduction: The deepithelialized free gingival graft (DGG) technique provides high-quality connective tissue grafts (CTGs) with predictable outcomes for recession cov-erage. This study evaluates a novel method of free gingival graft (FGG) deepithelialization using an Er,Cr:YSGG laser (LDEE) for treating multiple gingival recessions. Methods: A split-mouth study was conducted on 46 (n=46) recessions in 9 patients (23 per test and control group). Sites were randomized. Full-thickness palatal grafts were harvested with a scalpel. In the test group (LDEE), deepithelialization was performed extraorally using an Er,Cr:YSGG laser (2780 nm; 2.5 W, 83.3 mJ, 30 Hz, 600 µm tip). In the control group (DEE), a 15c scalpel was used. All CTGs were applied using the modified coronally advanced tunnel (TUN) technique. Clinical parameters-recession depth (RD), keratinized tissue width (KT), gingival thickness (GT), pocket depth (PD), clinical attachment loss (CAL), pink esthetic score (PES), approximal plaque index (API), mean root coverage (MRC), and complete root coverage (CRC)-were assessed at baseline (T0), 3 months (T1), and 6 months (T2). Results: Both LDEE and DEE groups showed significant improvements in RD, KT, GT, PD, and CAL over time (p \\< 0.001). At T1 and T2, KT was significantly higher in the LDEE group (T1: 3.73±0.72 mm; T2: 3.98±0.76 mm) compared to the DEE group (T1: 3.21±0.61 mm; T2: 3.44±0.74 mm; p \\< 0.05). Other parameters (RD, GT, PD, CAL) showed no statistically significant intergroup differences at any time point (p \\> 0.05). After 6 months, MRC was 95% and CRC 82.6% for LDEE, compared to 94.8% and 82.6% for DEE (p \\> 0.05). PES scores were similar between groups at all time points (p \\> 0.05). Conclusion: Both laser- and scalpel-deepithelialized grafts effectively treated gingival recessions. LDEE combined with TUN resulted in significantly greater KT width compared to DEE + TUN.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 70 years\n* Presence of multiple Miller Class I or II gingival recessions\n* Good general and oral health\n* Patient consent to participate in the clinical trial\n* Availability for follow-up at 3 and 6 months\n\nExclusion Criteria:\n\n* Smoking or history of smoking in the last 6 months\n* Systemic diseases affecting wound healing (e.g., diabetes, immunodeficiencies)\n* Pregnancy or lactation\n* Use of medications that influence periodontal tissues (e.g., immunosuppressants, corticosteroids)\n* History of periodontal surgery in the area of interest within the past 12 months Inadequate oral hygiene (plaque index \\>20%)'}, 'identificationModule': {'nctId': 'NCT07064304', 'briefTitle': 'Er,Cr:YSGG Laser for Deepithelialization in Gingival Recession.', 'organization': {'class': 'OTHER', 'fullName': 'Wroclaw Medical University'}, 'officialTitle': 'Clinical Efficacy of Er,Cr:YSGG Laser for Deepithelialization of Free Gingival Grafts in Gingival Recession Treatment: A Randomized, Split-Mouth Clinical Trial', 'orgStudyIdInfo': {'id': 'WroclawMU6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laser Deepithelialization (LDEE)', 'description': 'In this arm, deepithelialization of the free gingival graft was performed extraorally using an Er,Cr:YSGG laser (2780 nm; 2.5 W; 83.3 mJ; 30 Hz; 600 μm tip) before graft placement at the recipient site.', 'interventionNames': ['Procedure: Laser Deepithelialization of Free Gingival Graft']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Scalpel Deepithelialization (DEE)', 'description': 'In this arm, the epithelium was removed manually using a 15c surgical scalpel from the harvested palatal free gingival graft before placement.', 'interventionNames': ['Procedure: Scalpel Deepithelialization of Free Gingival Graft']}], 'interventions': [{'name': 'Laser Deepithelialization of Free Gingival Graft', 'type': 'PROCEDURE', 'description': 'Extraoral deepithelialization of harvested free gingival graft using Er,Cr:YSGG laser (2780 nm, 2.5 W, 83.3 mJ, 30 Hz, 600 μm tip) before placement in gingival recession treatment.', 'armGroupLabels': ['Laser Deepithelialization (LDEE)']}, {'name': 'Scalpel Deepithelialization of Free Gingival Graft', 'type': 'PROCEDURE', 'description': 'Extraoral deepithelialization of harvested free gingival graft using a 15c surgical scalpel blade before placement in gingival recession treatment.', 'armGroupLabels': ['Scalpel Deepithelialization (DEE)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43-300', 'city': 'Bielsko-Biala', 'country': 'Poland', 'facility': 'Dentoplex', 'geoPoint': {'lat': 49.82245, 'lon': 19.04686}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Although this was a prospective clinical study, we do not plan to share individual participant data (IPD) due to lack of consent for data sharing obtained at the time of enrollment.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wroclaw Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}