Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT04232202
Status:
COMPLETED
Last Update Posted:
2022-03-09
First Post:
2020-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Socket Preservation With Er:YAG and Nd:YAG Lasers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'CBCT will be used to assess bone density and the assessors will be unaware of the patient allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomly assigned to either laser or control group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-08', 'studyFirstSubmitDate': '2020-01-14', 'studyFirstSubmitQcDate': '2020-01-14', 'lastUpdatePostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in bone density from immediate post-extraction', 'timeFrame': '3 months', 'description': 'Cone Beam Computed Tomography (CBCT)'}], 'secondaryOutcomes': [{'measure': 'Bone density', 'timeFrame': '3 months', 'description': 'Cone Beam Computed Tomography (CBCT)'}, {'measure': 'Bone thickness', 'timeFrame': '3 months', 'description': 'Cone Beam Computed Tomography (CBCT)'}, {'measure': 'Treatment pain', 'timeFrame': 'day 1', 'description': 'On a pain scale from 0 (no pain) to 10 (intolerable pain)'}, {'measure': 'Treatment pain', 'timeFrame': 'day 3', 'description': 'On a pain scale from 0 (no pain) to 10 (intolerable pain)'}, {'measure': 'Treatment pain', 'timeFrame': 'day 5', 'description': 'On a pain scale from 0 (no pain) to 10 (intolerable pain)'}, {'measure': 'Treatment pain', 'timeFrame': 'day 7', 'description': 'On a pain scale from 0 (no pain) to 10 (intolerable pain)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tooth extraction', 'alveolar bone', 'bone regeneration', 'laser'], 'conditions': ['Post-extraction Bone Regeneration']}, 'descriptionModule': {'briefSummary': 'Alveolar bone regeneration after laser-assisted extraction will be compared with bone regeneration after standard extraction procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient requires at least one simple extraction\n* Voluntary informed consent to participate in the study\n\nExclusion Criteria:\n\n* Pregnancy\n* Use of photosensitizing medication\n* Refuse participation\n* Require complicated extraction'}, 'identificationModule': {'nctId': 'NCT04232202', 'briefTitle': 'Socket Preservation With Er:YAG and Nd:YAG Lasers', 'organization': {'class': 'OTHER', 'fullName': 'Krizaj d.o.o.'}, 'officialTitle': 'Post-extraction Treatment With Er:YAG and Nd:YAG Lasers - Socket Preservation', 'orgStudyIdInfo': {'id': 'Socket preservation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laser', 'description': 'After extraction, Er:YAG and Nd:YAG lasers used for degranulation, disinfection, deepithelialization, clot stabilization and photobiomodulation.', 'interventionNames': ['Device: Er:YAG and Nd:YAG lasers']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Standard extraction procedure.', 'interventionNames': ['Procedure: Standard extraction']}], 'interventions': [{'name': 'Er:YAG and Nd:YAG lasers', 'type': 'DEVICE', 'otherNames': ['Twinlight', 'laser alveolar preservation', 'LightWalker', 'Fotona'], 'description': 'Extraction followed by Er:YAG laser degranulation, Nd:YAG laser disinfection, Er:YAG deepithelialization, Nd:YAG blood clot stabilization and photobiomodulation. The photobiomodulation step repeated on day 3, 5, and 7.', 'armGroupLabels': ['Laser']}, {'name': 'Standard extraction', 'type': 'PROCEDURE', 'description': 'Standard extraction procedure', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Klinika Križaj', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Aleksandra Križaj Dumić, MDD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Krizaj d.o.o.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Krizaj d.o.o.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}