Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT05787912
Status:
COMPLETED
Last Update Posted:
2023-03-28
First Post:
2023-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Hyaluronic Acid Gel and Photobiomodulation on Wound Healing After Surgical Gingivectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005885', 'term': 'Gingival Hyperplasia'}], 'ancestors': [{'id': 'D019214', 'term': 'Gingival Overgrowth'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-15', 'studyFirstSubmitDate': '2023-03-15', 'studyFirstSubmitQcDate': '2023-03-15', 'lastUpdatePostDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wound healing', 'timeFrame': 'up to 21 days', 'description': "Assessed using Landry's healing index which grades the wound on a scale of 1 (poor) to 5 (excellent)\n\n* Very poor (1): ≥50% of gingiva red, bleeding on palpation, Granulation tissue present, Non-epithelialized incision margin with loss of epithelium beyond the margin.\n* Poor (2): ≥50% of gingiva red, bleeding on palpation, Granulation tissue present, Non-epithelialized incision margin with exposed connective tissue\n* Good (3): ≥25% and\\<50% of gingiva red, No bleeding on palpation, no granulation tissue, No exposed connective tissue on the incision margin\n* Very good (4): \\<25% of gingiva red, No bleeding on palpation, no granulation tissue, No exposed connective tissue on the incision margin\n* Excellent (5): All tissues are pink, No bleeding on palpation, no granulation tissue, No exposed connective tissue on the incision margin"}, {'measure': 'Perceived pain', 'timeFrame': 'up to 21 days', 'description': 'This was assessed using Visual Analogue Scale (VAS). Patients were instructed to chart their perceptions of pain using VAS ranging from 0-10; where 0 represents no pain/burning sensation and 10 represents severe pain/burning sensation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Surgical gingivectomy', 'Hyaluronic acid', 'Photobiomodulation'], 'conditions': ['Gingival Enlargement']}, 'referencesModule': {'references': [{'pmid': '37891549', 'type': 'DERIVED', 'citation': 'Yakout BK, Kamel FR, Khadr MAEA, Heikal LAH, El-Kimary GI. Efficacy of hyaluronic acid gel and photobiomodulation therapy on wound healing after surgical gingivectomy: a randomized controlled clinical trial. BMC Oral Health. 2023 Oct 27;23(1):805. doi: 10.1186/s12903-023-03519-5.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the effect of hyaluronic acid gel after photobiomodulation on the healing of surgical gingivectomy sites'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic inflammatory gingival enlargement grade 2 and 3 according to the gingival overgrowth index by Miller and Damn.\n* Adequate amount of keratinized tissue.\n* Attachment loss= 0\n* Well educated patients as post-operative instructions need to be followed precisely.\n\nExclusion Criteria:\n\n* Patients with history of smoking\n* Pregnant women\n* Patients with bad oral hygiene\n* Patients who have any known systemic disease that interfere with performance of surgical gingivectomy or periodontal wound healing\n* Patients who have any previous adverse reactions to the products (or similar products) used in this study'}, 'identificationModule': {'nctId': 'NCT05787912', 'briefTitle': 'Efficacy of Hyaluronic Acid Gel and Photobiomodulation on Wound Healing After Surgical Gingivectomy', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Efficacy of Hyaluronic Acid Gel and Photobiomodulation on Wound Healing After Surgical Gingivectomy: a Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '#1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Photobiomodulation', 'interventionNames': ['Device: Photobiomodulation']}, {'type': 'EXPERIMENTAL', 'label': 'Hyaluronic acid gel after photobiomodulation', 'interventionNames': ['Other: Hyaluronic acid after photobiomodulation']}], 'interventions': [{'name': 'Photobiomodulation', 'type': 'DEVICE', 'description': 'The surgical sites were irradiated with a diode laser (980 nm, 0.2W) only.', 'armGroupLabels': ['Photobiomodulation']}, {'name': 'Hyaluronic acid after photobiomodulation', 'type': 'OTHER', 'description': 'The surgical sites after gingivectomy were irradiated with a diode laser (980 nm, 0.2W) then covered by 2% Hyaluronic acid gel loaded in a special appliance for each patient.', 'armGroupLabels': ['Hyaluronic acid gel after photobiomodulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Basma K Yacout, BDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University'}, {'name': 'Fatma R Kamel, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}, {'name': 'Maha A Abou Khadr, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}, {'name': 'Lamia A Heikal, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Pharmacy, Alexandria University'}, {'name': 'Gillan I El-Kimary, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Alexandria University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of Periodontology', 'investigatorFullName': 'Basma Khalil', 'investigatorAffiliation': 'Alexandria University'}}}}