Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-30 @ 12:19 AM
Study NCT ID:
NCT04377256
Status:
COMPLETED
Last Update Posted:
2025-04-03
First Post:
2020-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyaluronic Acid Effect on Xenogenic Bone Healing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001862', 'term': 'Bone Resorption'}, {'id': 'D016388', 'term': 'Tooth Loss'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2020-05-03', 'studyFirstSubmitQcDate': '2020-05-03', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiological assessement of the boe resorption', 'timeFrame': '4 months', 'description': 'the baseline if the CBCT is compared to the 4 months post-op to assess the bone resorption'}, {'measure': 'Histomorphometric analysis', 'timeFrame': '4 months', 'description': 'During implant placement, a bone biopsy is harvested and stained with different colorants to assess microscopically the biological healing'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tooth extraction', 'ridge preservation', 'hyaluronic acid', 'dental implant'], 'conditions': ['Bone Resorption', 'Tooth Loss']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to test the hyaluronic acid hydrogel impact on the healing acceleration of xenogenic bone substitutes used in ridge preservation.\n\nFollowing tooth extraction, bone particles are mixed with the hyaluronic acid gel and grafted in the tooth socket. at the implant placement phase, a cone beam computer assisted tomography file is recorded in order to compare it with the baseline and a biopsy to evaluate the histological consequences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in need of tooth extraction and willing to receive dental implants in the extraction site\n* Presence of two mono radicular teeth in need of extraction\n\nExclusion Criteria:\n\n* Patients with systemic diseases\n* Patients under 8 years and above 60 years.\n* Presence of endodontic or periodontal lesion in the extraction sites'}, 'identificationModule': {'nctId': 'NCT04377256', 'briefTitle': 'Hyaluronic Acid Effect on Xenogenic Bone Healing', 'organization': {'class': 'OTHER', 'fullName': 'Saint-Joseph University'}, 'officialTitle': 'Hyaluronic Acid Effect on Xenogenic Bone Substitutes Healing During Ridge Preservations: A Radiological and Histomorphometric Study', 'orgStudyIdInfo': {'id': 'USJ-2019-267'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiological assessement', 'description': 'Two CBCTs were recorded and compared, one at the baseline and the other at 4 months post-op. The bone resorption was quantified and analyzed using ITK-SNAP software', 'interventionNames': ['Procedure: Ridge preservation: Tooth extration and immediat bone grafting in the socket']}, {'type': 'EXPERIMENTAL', 'label': 'Histomorphometric analysis', 'description': 'During implant placement (4 months after the bone grafting), a bone biopsy is collected and stained with several colorants to analyze the biological bone healing', 'interventionNames': ['Procedure: Ridge preservation: Tooth extration and immediat bone grafting in the socket']}], 'interventions': [{'name': 'Ridge preservation: Tooth extration and immediat bone grafting in the socket', 'type': 'PROCEDURE', 'description': 'Following the tooth extraction, the socket is filled with a mixture of xenogenic bone and hyaluronic acid and sealed with an epithelio-connective arrested from the maxillary palate', 'armGroupLabels': ['Histomorphometric analysis', 'Radiological assessement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1104 2020', 'city': 'Beirut', 'state': 'Lebanon', 'country': 'Lebanon', 'facility': 'Saint-Joseph university', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'city': 'Beirut', 'country': 'Lebanon', 'facility': 'Universte Saint Joseph-Beyrouth', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'overallOfficials': [{'name': 'Ronald J Younes, Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of oral surgery department, facuty of dentistry ,Universite SainT Joseph-Beyrouth'}, {'name': 'Bachar A Husseini, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of oral surgery, facuty of dentistry ,Universite SainT Joseph-Beyrouth'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint-Joseph University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}