Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:19 PM
Study NCT ID:
NCT05766293
Status:
COMPLETED
Last Update Posted:
2023-03-13
First Post:
2023-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ESWT on Human Gingival Fibroblasts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017622', 'term': 'Periodontal Attachment Loss'}, {'id': 'D006965', 'term': 'Hyperplasia'}], 'ancestors': [{'id': 'D055093', 'term': 'Periodontal Atrophy'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'PCS-201-018 Fibroblast cell line (n=10) would be exposed to shockwave generator depending on Test group. Control group Fibroblast cell line (n=10) would be assessed without shockwave exposure. Cell proliferation and Cell viability will be assessed for both Test and Control Fibroblast cell lines using Scratch assay, MTT analysis and ATP analysis, accordingly.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-02', 'studyFirstSubmitDate': '2023-02-14', 'studyFirstSubmitQcDate': '2023-03-02', 'lastUpdatePostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fibroblast cell lines exposed to shockwave from extracorporeal shockwave device', 'timeFrame': '74 hrs', 'description': 'Cell proliferation and Cell viability'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cell culture', 'ESWT', 'Cell proliferation', 'Cell viability'], 'conditions': ['Periodontal Attachment Loss']}, 'descriptionModule': {'briefSummary': "The idea of treating different deformities or diseases in the maxillofacial region with Extracorporeal Shockwave Therapy (ESWT) has recently become popular. Shockwave therapy was first introduced in Germany in 1980s and has been widely used in medical practice for the management of urolithiasis, cholelithiasis and in head and neck region for sialolithiasis.\n\nThe present study 'Application of Extracorporeal Shock Wave Therapy on human gingival derived fibroblasts In-vitro study' was done to explore and evaluate the effect of shockwaves. Further, these cells were assessed for Cell - Cell interaction and Cell Viability.\n\nIn this in-vitro study, 20 fibroblast cells were included. 10 samples were considered for Control group and the remaining 10 samples were considered as Test group. Extracorporeal shockwave was applied to the Test samples. They were further analysed", 'detailedDescription': "BACKGROUND:\n\nImproved understanding of human biology at the molecular level, scientific and technologic advances are emerging aspects in dentistry. The idea of treating different deformities or diseases in the maxillofacial region with Extracorporeal Shockwave Therapy (ESWT) has recently become popular. Shockwave therapy was first introduced in Germany in 1980s and has been widely used in medical practice for the management of urolithiasis, cholelithiasis and in head and neck region for sialolithiasis.\n\nAIM:\n\nThe present study 'Application of Extracorporeal Shock Wave Therapy on human gingival tissue derived fibroblasts In-vitro study' was done to explore and evaluate the effect of shockwaves. Further, fibroblast cells were assessed for Cell - Cell interaction and Cell Viability.\n\nMATERIALS AND METHODS:\n\nIn this in-vitro study, 20 fibroblast cells were included. 10 samples were considered for Control group and the remaining 10 samples were considered as Test group. Extracorporeal shockwave was applied to the Test samples. They were further analysed using wound scratch assay which was used to assess Cell proliferative rate and scratch closure through live imaging. MTT assay and ATP assay was used to determine Cell viability after exposure to shockwaves."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Viable human gingival fibroblast\n* Healthy gingival tissue\n\nExclusion Criteria:\n\n* contaminated samples'}, 'identificationModule': {'nctId': 'NCT05766293', 'acronym': 'ESWT', 'briefTitle': 'ESWT on Human Gingival Fibroblasts', 'organization': {'class': 'OTHER', 'fullName': 'Krishnadevaraya College of Dental Sciences & Hospital'}, 'officialTitle': 'Application of Extracorporeal Shockwaves on Human Gingival Fibroblasts in Vitro Study', 'orgStudyIdInfo': {'id': 'KCDS/48'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Shockwave treated group', 'description': 'Effect of Extracorporeal shockwaves on Fibroblast cell proliferation and cell viability', 'interventionNames': ['Device: extracorporeal shockwave device']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'No shockwave group', 'description': 'Fibroblast cell lines assessed for proliferative rate and viability without shockwave exposure.', 'interventionNames': ['Other: Fibroblast cell lines not subjected to shockwaves from extracorporeal shockwave device']}], 'interventions': [{'name': 'extracorporeal shockwave device', 'type': 'DEVICE', 'description': 'Fibroblast cell lines (n=10) were subjected to Shockwaves from extracorporeal shockwave device', 'armGroupLabels': ['Shockwave treated group']}, {'name': 'Fibroblast cell lines not subjected to shockwaves from extracorporeal shockwave device', 'type': 'OTHER', 'description': 'Fibroblast cell lines (n=10) without shockwave exposure', 'armGroupLabels': ['No shockwave group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '562157', 'city': 'Bengaluru', 'state': 'Karnataka', 'country': 'India', 'facility': 'Krishnadevaraya College of Dental Science and Hospital', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr Prabhuji MLV', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, Head of Periodontology, Principle investigator, Clinical Professor', 'investigatorFullName': 'Dr Prabhuji MLV', 'investigatorAffiliation': 'Krishnadevaraya College of Dental Sciences & Hospital'}}}}