Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-03-05 @ 8:33 PM
Study NCT ID:
NCT03946020
Status:
COMPLETED
Last Update Posted:
2019-05-10
First Post:
2019-05-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GBR and Autogenous Bone Chips
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001862', 'term': 'Bone Resorption'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Split mouth'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-09', 'studyFirstSubmitDate': '2019-05-02', 'studyFirstSubmitQcDate': '2019-05-09', 'lastUpdatePostDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Horizontal and vertical bone augmentation', 'timeFrame': '16 weeks', 'description': 'The change of dimension was assessed comparing Cone Beam Computed Tomography scans (CBCT)'}], 'secondaryOutcomes': [{'measure': 'Success of grafting procedure as assessed by clinical interpretation', 'timeFrame': '1 year', 'description': 'Defined as no persistent pain in the grafted area and no suppuration or expulsion of graft material and implant survival rates being lack of mobility, absence of peri-implant radiolucency, absence of recurrent peri-implant infection with suppuration, absence of continuous or recurrent pain, and no structural failure of the implant'}, {'measure': 'Marginal bone level alterations assessed on peri-apical radiographs using software (ImageJ)', 'timeFrame': '1 year', 'description': 'measured from a reference point (implant shoulder) to the most coronal point of BIC, both mesially and distally'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['implants; GBR; DBBM; grafts; bone'], 'conditions': ['Bone Resorption']}, 'referencesModule': {'references': [{'pmid': '31602699', 'type': 'DERIVED', 'citation': 'Temmerman A, Cortellini S, Van Dessel J, De Greef A, Jacobs R, Dhondt R, Teughels W, Quirynen M. Bovine-derived xenograft in combination with autogenous bone chips versus xenograft alone for the augmentation of bony dehiscences around oral implants: A randomized, controlled, split-mouth clinical trial. J Clin Periodontol. 2020 Jan;47(1):110-119. doi: 10.1111/jcpe.13209. Epub 2019 Nov 5.'}]}, 'descriptionModule': {'briefSummary': "This study will be an open, prospective, split-mouth, randomised controlled clinical trial. A total of 14 patients searching for oral implant treatment and where a GBR procedure is indicated per implant treatment will be enrolled.\n\nAll patients have to fulfill all of the inclusion criteria and none of the exclusion criteria. From all patients clinical photos will be taken.\n\nTwo sites within a patient will be randomly allocated to the 'autologous bone chips and DBBM or 'DBBM particles alone' group.\n\nThe study will be 1 year follow-up study comprising 9 visits", 'detailedDescription': 'A randomized controlled clinical trial (RCT) to compare the use of deproteinized bovine bone mineral (DBBM) in combination with autogenous bone chips versus a DBBM alone for the augmentation of bony dehiscence after dental implant placement\n\nObjectives: 1. To test whether the use of DBBM is not inferior to the use of a combination of DBBM and autogenous bone chips for the filling of bony dehiscence around dental implants\n\n2\\. To test whether a digital impression technique can be used to measure guided bone regeneration in comparison to conventional measurement with a dental probe and to compare these observations with cone beam CT images\n\nStudy Design: Randomized, controlled, single center, split mouth study\n\nStudy Population: Partially edentulous male or female patients in need for oral implants for a fixed prosthetic implant supported rehabilitation and where a Guide Bone Regeneration (GBR) procedure is indicated during implant treatment\n\nPatient Number: 14\n\nDuration of treatment: The time in the study for each patient will be 1 year and 4 months. The treatment period includes implant and abutment installation (in a twostage procedure), with a healing time of minimum 12 weeks before the start of the prosthetic phase.\n\nStudy devices: Implants: 3.3 / 4.1 / 4.8 mm Straumann Bone level implants Bone Graft: DBB (Demineralised Bovine Bone, Bio OSS) Measuring Devices: Cadent iTero \\& software and Dental Probes Prosthetics: Straumann (computer aided design computer aided manufacturing (CAD CAM) crowns and abutments\n\nOutcome variables:\n\nPrimary outcome variable: Difference in bone fill between DBB + bone chips vs. DBB without bone chips afer 24 weeks of submerged healing. The "ideal bone volume" as defined at base line (= 100%) will be compared to the received bone fill \\[%\\] at re-entry measured by a digital impression technique (before and after GBR, and at abutment connection, before and after raising a flap, and at the 1-year follow-up).\n\nThe method of digital impression will be compared to CBCT immediately after implant placemetn and 1 year and periodontal probing during surgery and re-enty\n\nSecondary Parameters:\n\nPage 5 of 35 A comparison of 3 different tools (probe, CBCT and digital impression) for measuring the bone volume changes in relation to GBR procedures. Implant survival en success rates on a patient and implant level Marginal bone level alterations\n\nSafety: Adverse Events / Adverse Device Effects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years,\n* in need of a solitary implant in quadrant 1 and 2 or quadrant 3 and 4 with simultaneous GBR procedure\n* presence of a pre-operative CBCT.\n\nExclusion Criteria:\n\n* smokers\n* patients with systemic diseases that could interfere with the healing\n* patients undergoing bisphosphonate treatment\n* patients who previously received radiation therapy of the jaws\n* patients that received a GBR procedure in the region of interest in the past.'}, 'identificationModule': {'nctId': 'NCT03946020', 'briefTitle': 'GBR and Autogenous Bone Chips', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Bovine Derived Xenograft in Combination With Autogenous Bone Chips Versus Xenograft Alone for the Augmentation of Bony Dehiscences Around Oral Implants: a Randomized, Controlled, Split-mouth Clinical Trial', 'orgStudyIdInfo': {'id': 'S55609'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Augmentation with autologous bone + DBBM', 'description': 'A layer of autogenous bone chips was placed on the implant surface. On top of this a layer of DBBM (Bio-Oss™, Geistlich®, Wolhusen, Switserland) was placed, thereafter covered with a collagen membrane.', 'interventionNames': ['Procedure: Guided bone regeneration with or without autologous bone']}, {'type': 'EXPERIMENTAL', 'label': 'Augmentation with DBBM', 'description': 'A layer of DBBM was placed on the implant surface and thereafter covered with a collagen membrane. Care was taken to make both augmentations as comparable as possible by weighting the used amount of graft material.', 'interventionNames': ['Procedure: Guided bone regeneration with or without autologous bone']}], 'interventions': [{'name': 'Guided bone regeneration with or without autologous bone', 'type': 'PROCEDURE', 'description': 'Autogenous bone chips were collected. On each side a bone level implant was placed. The bone dehiscence was measured and was thereafter treated according to the GBR protocol. A resorbable native collagen was adapted to the defect.', 'armGroupLabels': ['Augmentation with DBBM', 'Augmentation with autologous bone + DBBM']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Andy Temmerman, DDS, MSc, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Wim Teughels', 'investigatorAffiliation': 'Universitaire Ziekenhuizen KU Leuven'}}}}