Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-31 @ 6:18 AM
Study NCT ID:
NCT04835532
Status:
UNKNOWN
Last Update Posted:
2021-09-29
First Post:
2021-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tenting Screws in Combination With Platelet Concentrate for Vertical Alveolar Ridge Augmentation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016301', 'term': 'Alveolar Bone Loss'}], 'ancestors': [{'id': 'D001862', 'term': 'Bone Resorption'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C043309', 'term': 'proliferation regulatory factors, human urine'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 69}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2021-03-16', 'studyFirstSubmitQcDate': '2021-04-04', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Bone density, BD', 'timeFrame': 'T2(6 months after GBR)', 'description': 'in the area of bone regeneration, ranging 2mm × 2mm'}], 'primaryOutcomes': [{'measure': 'Buccal bone augmentation, BBA(bone height changes between T0 and T2)', 'timeFrame': 'T0(before surgery), T2(6 months after GBR)', 'description': 'The sagittal plane of CBCT image is selected as the measuring plane, and the horizontal tangent of the inferior margin of maxillary sinus / paranasal sinus is selected as the baseline. The investigaters will measure the bone height changes by CBCT(three-dimensional CT) and Related measurement software. The unit of measurement is millimeter.'}], 'secondaryOutcomes': [{'measure': 'Lingual bone augmentation, LBA(bone height changes between T0 and T2)', 'timeFrame': 'T0(before surgery), T2(6 months after GBR)', 'description': 'The sagittal plane of CBCT image is selected as the measuring plane, and the horizontal tangent of the inferior margin of maxillary sinus / paranasal sinus is selected as the baseline.\n\nThe sagittal plane of CBCT image is selected as the measuring plane, and the horizontal tangent of the inferior margin of maxillary sinus / paranasal sinus is selected as the baseline.The investigaters will measure the bone height changes by CBCT(three-dimensional CT) and Related measurement software. The unit of measurement is millimeter.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tenting screws', 'advanced platelet rich fibrin', 'injectable platelet rich fibrin', 'guided bone regeneration'], 'conditions': ['Bone Loss, Alveolar']}, 'descriptionModule': {'briefSummary': 'Alveolar bone resorption often occurs after tooth extraction. At present, guided bone regeneration technique is widely used in clinic since it leads to less trauma and less complications. Tenting screw technology, basic on the classical GBR, implants screws into the surgical area to prevent the barrier membrane from collapsing. Moreover, advanced platelet rich fibrin and injectable platelet-rich fibrin are used to provide the osteogenic function. The investigators intend to increase vertical alveolar bone augmentation by combining tenting screws and A-PRF, I-PRF.', 'detailedDescription': 'Alveolar bone resorption often occurs after tooth extraction. At present, guided bone regeneration technique is widely used in clinic since it leads to less trauma and less complications. Tenting screw technology, basic on the classical GBR, implants screws into the surgical area to prevent the barrier membrane from collapsing. Moreover, advanced platelet rich fibrin and injectable platelet-rich fibrin are used to provide the osteogenic function. The investigators intend to increase vertical alveolar bone augmentation by combining tenting screws and A-PRF, I-PRF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18-80 years old;\n2. single tooth in the maxillary posterior area cannot be retained (third degree loosening / alveolar bone resorption to the periapical area), implantation is needed after extraction, and CBCT shows vertical bone defect ≥ 3mm;\n3. 4 weeks after extraction or missing teeth within 3-5 weeks;\n4. adjacent teeth exist and loosening is less than Ⅰ degree;\n5. periodontal disease in inactive stage, whole mouth bleeding index (FMBS) is less than 20%;\n6. thick gingival biological type.\n7. CBCT shows that the bone of the edentulous site meets the requirements of tent screw implantation (bone height ≥ 3mm and bone mineral density is sufficient);\n8. the patients and their families have informed consent and signed the informed consent form.\n\nExclusion Criteria:\n\n1. pregnant and lactating women;\n2. smoking (\\> 10 cigarettes per day) and alcoholism;\n3. taking anticoagulants within 3 months before operation;\n4. suffering from autoimmune diseases, diabetes, liver disease, blood system diseases and infectious diseases;\n5. patients taking any drugs that affect platelet function or whose platelet count is less than 200000/mm3 3 months before blood collection;\n6. patients who have been treated with bisphosphate / steroids for a long time;\n7. have received alveolar ridge bone augmentation surgery;\n8. previous history of radiotherapy in the head and neck;\n9. acute inflammation in edentulous sites;\n10. inability to maintain good oral hygiene or follow-up visits as required.'}, 'identificationModule': {'nctId': 'NCT04835532', 'briefTitle': 'Tenting Screws in Combination With Platelet Concentrate for Vertical Alveolar Ridge Augmentation', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Tenting Screws in Combination With Platelet Concentrate for Vertical Alveolar Ridge Augmentation: Prospective, Blinded, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2021-0050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control group', 'description': 'Vertical alveolar bone augmentation was performed by GBR technique before implantation.\n\nBIO-OSS+ BIO-GIDE barrier membrane', 'interventionNames': ['Procedure: guided bone gereration']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group 1', 'description': 'Vertical alveolar bone augmentation was performed by GBR technique and tenting screws before implantation.\n\nBIO-OSS+ BIO-GIDE barrier membrane+ tenting screws', 'interventionNames': ['Procedure: guided bone gereration']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group 2', 'description': 'Vertical alveolar bone augmentation was performed by GBR technique in combination with tenting screws and A-PRF, I-PRF before implantation.\n\nBIO-OSS+ BIO-GIDE barrier membrane+ tenting screws+A-PRF, I-PRF', 'interventionNames': ['Procedure: guided bone gereration']}], 'interventions': [{'name': 'guided bone gereration', 'type': 'PROCEDURE', 'otherNames': ['tenting screws, A-PRF, I-PRF'], 'description': 'guided bone generation: GBR is a procedure that uses barrier membranes with or without particulate bone grafts or/and bone substitutes.\n\ntenting screws: Screws are implanted in the surgical area to prevent the barrier membrane from collapsing.\n\nA-PRF/I-PRF: Obtained by autologous blood centrifugation.', 'armGroupLabels': ['Control group', 'Treatment group 1', 'Treatment group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': '陈 莉丽, Master', 'role': 'CONTACT', 'email': 'chenlili_1030@163.com', 'phone': '+86 13606507966'}], 'facility': '2nd Affiliated Hospital, School of Medicine, Zhejiang University, China', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': '陈 莉丽, Master', 'role': 'CONTACT', 'email': 'chenlili_1030@163.com', 'phone': '+86 13606507966'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}