Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-03-01 @ 9:54 PM
Study NCT ID:
NCT01942304
Status:
COMPLETED
Last Update Posted:
2019-11-01
First Post:
2013-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Evaluation of Anorganic Bovine Bone Mineral Versus Calcium Phosphosilicate Alloplastic Bone Putty in Direct Sinus Augmentation: a Spilt-mouth Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-30', 'studyFirstSubmitDate': '2013-09-10', 'studyFirstSubmitQcDate': '2013-09-10', 'lastUpdatePostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Implant success', 'timeFrame': '2nd stage, 6&12 months post-loading', 'description': 'Patients will be evaluated for clinical symptoms and implant success using predetermined criteria.'}], 'primaryOutcomes': [{'measure': 'Percentage of new bone growth in the maxillary sinus', 'timeFrame': '7 months(plus minus 1 month)', 'description': 'Difference between the percentage of new bone growth between the two groups as determined by histomorphometric analysis of bone cores retrieved during implant placement surgery.'}], 'secondaryOutcomes': [{'measure': 'Gain in vertical bone height', 'timeFrame': '6 months (plus or minus 1month)', 'description': 'Patients will be seen for radiographic evaluation post-sinus surgery. A cone beam computed tomography (CBCT) will be obtained and a blinded investigator will evaluate the vertical bone height at the sites.'}, {'measure': 'Radiographic bone density', 'timeFrame': '6 months (plus or minus 1 month)', 'description': 'Patients will be seen for radiographic evaluation. A cone beam computed tomography(CBCT) will be obtained and a blinded investigator will evaluate the volumetric grey values at each site as an index of bone quality.'}, {'measure': 'Primary implant stability', 'timeFrame': '7 months (plus or minus 1 month)', 'description': 'Primary stability of implants placed in the augmented sinuses will be evaluated as a clinical index of bone density.'}, {'measure': 'Marginal bone level maintenance', 'timeFrame': '12 months(plus or minus 1 month)', 'description': 'Intraoral radiographs, using a paralleling technique, with customized film holders will be obtained at baseline (time of abutment connection) and at the 12-month follow-up visit and evaluated by an independent investigator to assess marginal bone levels around the implant platform. The measurements will be performed mesially and distally of each implant.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sinus Floor Augmentation', 'Maxillary Sinus', 'Bone Substitutes', 'Bone Regeneration'], 'conditions': ['Sinus Floor Augmentation', 'Maxillary Sinus']}, 'referencesModule': {'references': [{'pmid': '12381063', 'type': 'BACKGROUND', 'citation': 'Hallman M, Sennerby L, Lundgren S. A clinical and histologic evaluation of implant integration in the posterior maxilla after sinus floor augmentation with autogenous bone, bovine hydroxyapatite, or a 20:80 mixture. Int J Oral Maxillofac Implants. 2002 Sep-Oct;17(5):635-43.'}, {'pmid': '15626319', 'type': 'BACKGROUND', 'citation': 'Del Fabbro M, Testori T, Francetti L, Weinstein R. Systematic review of survival rates for implants placed in the grafted maxillary sinus. Int J Periodontics Restorative Dent. 2004 Dec;24(6):565-77.'}, {'pmid': '23772806', 'type': 'BACKGROUND', 'citation': 'Mahesh L, Venkataraman N, Shukla S, Prasad H, Kotsakis GA. Alveolar ridge preservation with the socket-plug technique utilizing an alloplastic putty bone substitute or a particulate xenograft: a histological pilot study. J Oral Implantol. 2015 Apr;41(2):178-83. doi: 10.1563/AAID-JOI-D-13-00025. Epub 2013 Jun 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this split-mouth clinical study is to evaluate the clinical, radiographic and histological outcomes of lateral window sinus augmentation with a bovine xenograft or a CPS putty bone substitute in posterior maxillary sites and the survival of implants placed in these sites following healing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with non-contributory medical history that will present for bilateral sinus lift surgery prior to implant placement\n\nExclusion Criteria:\n\n* Patients that will not agree to participate in this study or sign the consent form\n* More than 8mm of residual bone height at the implant site\n* Subjects smoking more than 10 cigarettes per day\n* History of acute sinus infection\n* History of prior maxillary sinus surgery (Caldwell-Luc, direct or indirect sinus lift, etc)\n* Medications that affect bone healing (chronic steroid regimen, oral or IV bisphosphonates, etc.)\n* Patients allergic to bovine derivatives\n* Patients who are a carrier of transmissible disease(s) that may unnecessarily expose laboratory personnel to risks\n* Females during pregnancy or lactation or females that plan to become pregnant in the following year (pregnancy test prior to enrollment)'}, 'identificationModule': {'nctId': 'NCT01942304', 'briefTitle': 'Prospective Evaluation of Anorganic Bovine Bone Mineral Versus Calcium Phosphosilicate Alloplastic Bone Putty in Direct Sinus Augmentation: a Spilt-mouth Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Prospective Evaluation of Anorganic Bovine Bone Mineral Versus Calcium Phosphosilicate Alloplastic Bone Putty in Direct Sinus Augmentation: a Spilt-mouth Study', 'orgStudyIdInfo': {'id': '1308M40681'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Anorganic bovine bone mineral in direct sinus augmentation', 'description': 'Anorganic bovine bone mineral', 'interventionNames': ['Procedure: Anorganic bovine bone mineral in direct sinus augmentation']}, {'type': 'EXPERIMENTAL', 'label': 'Alloplastic bone putty in direct sinus augmentation', 'description': 'Alloplastic bone putty', 'interventionNames': ['Procedure: Calcium phosphosilicate alloplastic bone putty in direct sinus augmentation']}], 'interventions': [{'name': 'Calcium phosphosilicate alloplastic bone putty in direct sinus augmentation', 'type': 'PROCEDURE', 'armGroupLabels': ['Alloplastic bone putty in direct sinus augmentation']}, {'name': 'Anorganic bovine bone mineral in direct sinus augmentation', 'type': 'PROCEDURE', 'armGroupLabels': ['Anorganic bovine bone mineral in direct sinus augmentation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Advanced Education in Periodontology Clinic, Dental School, University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Georgios A Kotsakis, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}, {'name': 'James E Hinrichs, DDS, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'NovaBone Products, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}