Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2026-01-03 @ 9:16 PM
Study NCT ID:
NCT02692261
Status:
COMPLETED
Last Update Posted:
2016-02-26
First Post:
2016-02-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyaluronic Matrix Efficacy for Maxillary Sinus Augmentation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005402', 'term': 'Fistula'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059546', 'term': 'Sinus Floor Augmentation'}], 'ancestors': [{'id': 'D019647', 'term': 'Oral Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D016025', 'term': 'Bone Transplantation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-22', 'studyFirstSubmitDate': '2016-02-17', 'studyFirstSubmitQcDate': '2016-02-22', 'lastUpdatePostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of newly formed bone calculated from bone biopsises by Micro-CT and Histomorphometry', 'timeFrame': '4 months after surgery', 'description': 'Biological parameter obtained by analyzing bone biopsises'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sinus; Dental']}, 'descriptionModule': {'briefSummary': 'Sinus augmentation is a predictable method when alveolar bone height is not sufficient for dental implant placement in posterior maxillary alveolar region..The aim of this prospective, randomized, controlled clinical study is comparison of hyaluronic acid originated matrix and equine derived xenograft with only xenograft use in sinus augmentation by micro computed tomography and histomorphometry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '33 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systemically healthy patients\n* Requiring bilateral maxillary sinus augmentation (residual crest height ≤ 4 mm)\n\nExclusion Criteria:\n\n* Advanced systemic diseases\n* Chronic medication use\n* Maxillary sinus disease\n* Current pregnancy\n* Lactation\n* Smoking habit'}, 'identificationModule': {'nctId': 'NCT02692261', 'briefTitle': 'Hyaluronic Matrix Efficacy for Maxillary Sinus Augmentation', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Evaluation of Hyaluronic Matrix, Used With Xenograft, Efficacy in Sinus Augmentation by Histomorphometry and Micro Computed Tomography', 'orgStudyIdInfo': {'id': 'KA-14030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hyalossᵀᴹ matrix', 'description': 'Each 0.5 cc Collagenated Heterolog Bone Graft, mixed with two bundles of Hyalossᵀᴹ matrix and a few drops of sterile saline solution used for maxillary sinus augmentation', 'interventionNames': ['Procedure: Maxillary Sinus Augmentation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Apatos alone xenograft', 'description': 'Each sinus was filled with 1 gr xenograft (with or without Hyaluronic Acide) for maxillary sinus augmentation', 'interventionNames': ['Procedure: Maxillary Sinus Augmentation']}], 'interventions': [{'name': 'Maxillary Sinus Augmentation', 'type': 'PROCEDURE', 'otherNames': ['Hyaloss matrix'], 'description': 'Each 0.5 cc Collagenated Heterolog Bone Graft, mixed with two bundles of Hyalossᵀᴹ matrix and a few drops of sterile saline solution', 'armGroupLabels': ['Apatos alone xenograft', 'Hyalossᵀᴹ matrix']}, {'name': 'Maxillary Sinus Augmentation', 'type': 'PROCEDURE', 'description': 'Control group sinuses filled with heterolog bone graft alone', 'armGroupLabels': ['Apatos alone xenograft', 'Hyalossᵀᴹ matrix']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Feriha Caglayan, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'EZGİ DOĞAN', 'investigatorAffiliation': 'Hacettepe University'}}}}