Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2026-01-02 @ 10:18 AM
Study NCT ID:
NCT06764732
Status:
COMPLETED
Last Update Posted:
2025-01-08
First Post:
2025-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Socket Seal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2024-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-03', 'studyFirstSubmitDate': '2025-01-03', 'studyFirstSubmitQcDate': '2025-01-03', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'alveolar ridge dimensional changes in height and width measures', 'timeFrame': 'at base line and after 9 months'}], 'secondaryOutcomes': [{'measure': 'bone biopsy', 'timeFrame': 'after 9 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bio active glass', 'socket preservation'], 'conditions': ['Socket Sealing']}, 'referencesModule': {'references': [{'pmid': '41360883', 'type': 'DERIVED', 'citation': 'Hazzaa HH, Shiekh MAME, AbdAllah MF, Abdelgawad N, El-Mahdy MA, Shoshan HS, Elewa GM. Laser-assisted socket seal surgery using bioactive glass for dental implant site development: a randomized clinical trial. Sci Rep. 2025 Dec 9;15(1):43386. doi: 10.1038/s41598-025-28824-7.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.5051/jpis.2005120256', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'laser photo biomodulation (PBM) as a supplement to socket seal surgery', 'detailedDescription': 'the role of PBM therapy as an adjunct for bioactive glass graft in SSS approaches'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of at least a periodontal-affected and non-restorable tooth in posterior region (Class II sockets).\n* At least 10% plaque control scoring was accepted\n* A moderate to thick gingival phenotype\n\nExclusion Criteria:\n\n* systemic diseases or conditions that may compromise healing or bone metabolism,\n* having a history of radiotherapy, chemotherapy or bisphosphonate therapy, previous use of antibiotics in the last 3'}, 'identificationModule': {'nctId': 'NCT06764732', 'briefTitle': 'Socket Seal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Laser Assisted Socket Seal Surgery Using Bioactive Glass for Dental Implant Site Development', 'orgStudyIdInfo': {'id': 'DU:024100558'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'platelet rich fibrin membrane', 'interventionNames': ['Biological: Platelet rich fibrin']}, {'type': 'EXPERIMENTAL', 'label': 'test 1 group', 'description': 'bioactive glass', 'interventionNames': ['Biological: bioactive glass', 'Biological: Platelet rich fibrin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'test 2group', 'description': 'bioactive glass and Photobiomodulation', 'interventionNames': ['Biological: bioactive glass', 'Radiation: bioactive glass graft and PBM irradiation', 'Biological: Platelet rich fibrin']}], 'interventions': [{'name': 'bioactive glass', 'type': 'BIOLOGICAL', 'description': 'supplied as resorbable form, (400-800um) particle siz', 'armGroupLabels': ['test 1 group', 'test 2group']}, {'name': 'bioactive glass graft and PBM irradiation', 'type': 'RADIATION', 'description': 'The used laser parameters were set as: wavelength, 980 nm; power, 0.55 W; energy, 36 J; power density, 0.76 W cm2', 'armGroupLabels': ['test 2group']}, {'name': 'Platelet rich fibrin', 'type': 'BIOLOGICAL', 'description': '10 ml of blood was withdrawn from the patient and immediately centrifuged for 10 minutes at 3000 revolutions/min and the layer of fibrin clot was obtained', 'armGroupLabels': ['control group', 'test 1 group', 'test 2group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dakahlia', 'country': 'Egypt', 'facility': ', Faculty of Oral and Dental Medicine, Delta University for Science and Technology (DU), Dakahlia, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Nora Abdelgawad Mohamed', 'investigatorAffiliation': 'Al-Azhar University'}}}}