Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-01-01 @ 10:22 AM
Study NCT ID:
NCT04811768
Status:
COMPLETED
Last Update Posted:
2021-03-23
First Post:
2021-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lateral Bony Wall Repositioning in Maxillary Sinus Floor Augmentation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Histology analysis was performed blinded, randomization sequence was revealed after histomorphometry'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '40 patients underwent sinus floor augmentation - 20 patients treated by bony wall repositioning, 20 patients treated by collagen membrane coverage'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-19', 'studyFirstSubmitDate': '2021-03-09', 'studyFirstSubmitQcDate': '2021-03-19', 'lastUpdatePostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of surgery', 'timeFrame': 'During smaxillary sinus augmentation', 'description': 'Recorded in minutes'}], 'secondaryOutcomes': [{'measure': 'Duration of lateral window preparation', 'timeFrame': 'During maxillary sinus augmentation', 'description': 'Recorded in minutes'}, {'measure': 'Duration of mucosa preparation', 'timeFrame': 'During maxillary sinus augmentation', 'description': 'Recorded in minutes'}, {'measure': 'Visual Analog Scale (Minimum value 0, Maximum value 100, the higher the worse)', 'timeFrame': '12 hours postoperatively', 'description': 'Measurement of patient discomfort'}, {'measure': 'Visual Analog Scale (Minimum value 0, Maximum value 100, the higher the worse)', 'timeFrame': '1 day postoperatively', 'description': 'Measurement of patient discomfort'}, {'measure': 'Postoperative Edema Score', 'timeFrame': '2 days postoperatively', 'description': 'Measurement of swelling'}, {'measure': 'Postoperative Edema Score', 'timeFrame': '3 days postoperatively', 'description': 'Measurement of swelling'}, {'measure': 'Histomorphometrical analysis', 'timeFrame': 'Following reentry 6 months after maxillary sinus augmentation', 'description': 'Percentage of newly formed bone, bone substitute and connective tissue'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['maxillary sinus', 'xenogeneic graft', 'collagen membrane', 'lateral bony wall repositioning', 'piezoelectric surgery'], 'conditions': ['Maxillary Sinus Augmentation']}, 'referencesModule': {'references': [{'pmid': '35593928', 'type': 'DERIVED', 'citation': 'Molnar B, Jung AK, Papp Z, Martin A, Orban K, Prohl A, Jung O, Barbeck M, Windisch P. Comparative analysis of lateral maxillary sinus augmentation with a xenogeneic bone substitute material in combination with piezosurgical preparation and bony wall repositioning or rotary instrumentation and membrane coverage: a prospective randomized clinical and histological study. Clin Oral Investig. 2022 Aug;26(8):5261-5272. doi: 10.1007/s00784-022-04494-x. Epub 2022 May 20.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present prospective randomized controlled study is to clinically and histologically investigate the safety and efficacy of bony wall repositioning compared to rotary window preparation with membrane coverage in maxillary sinus floor augmentation.', 'detailedDescription': '40 patients were randomly divided in two study groups after radiological and clinical evaluation. Both groups received bone grafting by a xenogeneic bone substitute (BSM, cerabone, botiss biomaterials GmbH, Zossen, Germany) using the lateral approach. In the bony wall group (BW), following piezosurgery the retrieved bony wall was repositioned. In the collagen membrane group (CM), the lateral window was created by rotary instruments, covered via a native collagen membrane (collprotect, botiss biomaterials GmbH, Zossen, Germany). After 6 months, biopsies were taken to analyze both approaches in terms of new bone formation. Duration of treatment, the number of perforations, postoperative patient discomfort were registered. Established histopathological analysis and histomorphometrical measurements to analyze the tissue reactions and the tissue distribution, i.e., the fractions of newly formed bone tissue (NB), of remaining bone substitute material (BSM) and connective tissue (CT), were conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least one missing maxillary premolar or molar\n* at least 7 mm crestal bone width confirmed by preoperative ConeBeam Tomography (CBCT)\n* maximally 5 mm residual bone height at the sinus floor confirmed by preoperative ConeBeam Tomography (CBCT)\n* full mouth plaque and bleeding scores (FMPS and FMBS) \\<20%\n* satisfactory patient compliance (e.g. to participate in follow-up procedures)\n* signed informed consent.\n\nExclusion Criteria:\n\n* clinically relevant diseases (e.g.: diabetes, rheumatism cancer)\n* untreated periodontitis\n* systemic steroid use\n* bisphosphonate use\n* acute or chronic inflammatory processes\n* previous endoscopic sinus surgery\n* previous sinus floor elevation\n* GBR-treatment at the study site\n* GTR-treatment at the study site\n* tooth removal within 6 weeks prior to surgery'}, 'identificationModule': {'nctId': 'NCT04811768', 'briefTitle': 'Lateral Bony Wall Repositioning in Maxillary Sinus Floor Augmentation', 'organization': {'class': 'OTHER', 'fullName': 'Semmelweis University'}, 'officialTitle': 'Comparative Clinical and Histological Investigation of Graft Integration Following Piezosurgically Retrieved Lateral Bony Wall Repositioning in Maxillary Sinus Floor Augmentation - Prospective Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'Sinus-Semmelweis-Perio'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bony wall group', 'description': 'In the bony wall group, following piezosurgery the retrieved bony wall was repositioned.', 'interventionNames': ['Procedure: Maxillary sinus augmentation']}, {'type': 'EXPERIMENTAL', 'label': 'Collagen membrane group', 'description': 'In the collagen membrane group, the lateral window was created by rotary instruments, covered via a native collagen membrane (collprotect, botiss biomaterials GmbH, Zossen, Germany).', 'interventionNames': ['Procedure: Maxillary sinus augmentation']}], 'interventions': [{'name': 'Maxillary sinus augmentation', 'type': 'PROCEDURE', 'otherNames': ['Sinus lift'], 'description': 'The surgery was performed under local anaesthesia in both groups, lateral window preparation and window coverage was carried out based on randomization.', 'armGroupLabels': ['Bony wall group', 'Collagen membrane group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1088', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Semmelweis University Department of Periodontology', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Semmelweis University', 'class': 'OTHER'}, 'collaborators': [{'name': 'NSK Europe GmbH', 'class': 'INDUSTRY'}, {'name': 'Botiss Medical AG', 'class': 'OTHER'}, {'name': 'Institut Straumann AG', 'class': 'INDUSTRY'}, {'name': 'Dicomlab Kft.', 'class': 'UNKNOWN'}, {'name': 'Hungarian Human Resources Development Operational Program (EFOP-3.6.2-16-2017-00006)', 'class': 'UNKNOWN'}, {'name': 'Excellence Program of the Ministry for Innovation and Technology in Hungary', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Balint Molnar DMD, PhD, associate professor', 'investigatorFullName': 'Balint Molnar', 'investigatorAffiliation': 'Semmelweis University'}}}}