Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT07250256
Status:
COMPLETED
Last Update Posted:
2025-11-26
First Post:
2025-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiographic and Histomorphometric Evaluation of Xenograft as a Socket Preservation Material in Maxillary Posterior Teeth.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is an In-Vivo comparative randomized controlled study that will be conducted on patients of the outpatient clinic of Oral and Maxillofacial department Suez Canal University to evaluate the difference between using S1-XB bone graft as a socket preservation material and normal socket healing without adding any socket preservation materials.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-23', 'studyFirstSubmitDate': '2025-08-16', 'studyFirstSubmitQcDate': '2025-11-23', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Histomorphometric analysis', 'timeFrame': '16 weeks', 'description': "Samples were first stained with hematoxylin and eosin (H\\&E) to demonstrate the general tissue architecture, cellular distribution, and overall structural organization. Subsequently, sections were stained with Masson's Trichrome (MTC) to allow both qualitative and quantitative assessment of bone trabeculae and osteoid tissue. Osteopontin (OPN) immunohistochemistry was used to assess the percentage of OPN expression area within the surrounding connective tissue. The OPN poly-colonal antibody was purchased from Thermo Fisher Scientific, Catalog # PA1-72061. Images were captured at ×400 magnification using a SOPTOP EX20 microscope with HD camera. ImageJ software was used to quantify area% from five standardized fields per section at oral pathology laboratory, Faculty of Dentistry, Suez Canal University."}, {'measure': 'Radiographic evaluation', 'timeFrame': '16 weeks', 'description': 'Cone-beam computed tomography (CBCT) scans (Scanora 3D) were obtained immediately after extraction at baseline and postponed at 4 months postoperatively to evaluate the following parameters: bone density that was measured in Hounsfield units (HU) at the center of the socket, ridge height that was determined by vertical distance from the crestal bone to a fixed reference point and ridge width that was measured at 3 mm apical to the crest.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Socket', 'Healing', 'bone formation', 'histomorphometery'], 'conditions': ['Socket Preservation']}, 'descriptionModule': {'briefSummary': 'Radiographic and Histomorphometric Evaluation of Xenograft as a Socket Preservation Material in Maxillary Posterior Teeth: A Randomized-Controlled Clinical Study', 'detailedDescription': 'The process of natural healing starts with new bone formation taking place from initial islands of bone within the connective tissue occurring after a 4 to 8 weeks interval from extraction date. This is followed by the manifestation of a mature trabecular structure that can be noticed at 10 to 20 weeks after extraction accompanied with a reduction in osteoblast count. As a result of the extensive bone resorption post extraction, the prosthetically driven implant placement is compromised and in need of some ridge preservation techniques that have been widely studied to try and ensure less alveolar bone loss. The aim of this research is to study the S1-XB Xenograft containing hydrogel and to evaluate its effects on extraction socket healing in comparison to natural socket healing. This is an In-Vivo comparative randomized controlled study that will be conducted on patients of the outpatient clinic of Oral and Maxillofacial department Suez Canal University to evaluate the difference between using S1-XB bone graft as a socket preservation material and normal socket healing without adding any socket preservation materials.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '21 Years', 'genderBased': True, 'genderDescription': 'males with general good health. Non smokers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male patients aged between 21 and 40 years.\n* General good health.\n* Absence of any relevant systemic disease.\n* Presence of a hopeless maxillary posterior tooth that requires extraction.\n* Extraction site suitable for replacement by a dental implant.\n* Cases have adequate bone width and length.\n* Volunteer subjects must sign an informed consent.\n\nExclusion Criteria:\n\n* Poor oral hygiene with no possibility of improvement.\n* Smokers (more than 10 cigarettes per day).\n* Chronic treatment with any medication known to affect oral status and bone turnover.\n* Drug or alcohol abuse.'}, 'identificationModule': {'nctId': 'NCT07250256', 'briefTitle': 'Radiographic and Histomorphometric Evaluation of Xenograft as a Socket Preservation Material in Maxillary Posterior Teeth.', 'organization': {'class': 'OTHER', 'fullName': 'Suez Canal University'}, 'officialTitle': 'Radiographic and Histomorphometric Evaluation of Xenograft as a Socket Preservation Material in Maxillary Posterior Teeth: A Randomized-Controlled Clinical Study', 'orgStudyIdInfo': {'id': '547-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Study group', 'description': '(8 cases): was treated by immediate socket preservation with S1-XB xenograft augmentation after extraction.', 'interventionNames': ['Device: S1-XB']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': '(8 cases): was not exposed to any type of socket preservation after the extraction procedure.', 'interventionNames': ['Procedure: Control (Standard treatment)']}], 'interventions': [{'name': 'S1-XB', 'type': 'DEVICE', 'description': 'Socket grafted with xenograft containing alginate hydrogel material', 'armGroupLabels': ['Study group']}, {'name': 'Control (Standard treatment)', 'type': 'PROCEDURE', 'description': 'Atraumatic extraction and sockets were allowed to undergo normal healing without any graft materials', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ismailia', 'country': 'Egypt', 'facility': 'Suez Canal university', 'geoPoint': {'lat': 30.60427, 'lon': 32.27225}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suez Canal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}