Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-03-02 @ 4:23 PM
Study NCT ID:
NCT01771302
Status:
COMPLETED
Last Update Posted:
2021-08-23
First Post:
2013-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficiency of PRGF-Endoret in Combination With a Bone Graft in Lateral Sinus Floor Elevation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-20', 'studyFirstSubmitDate': '2013-01-15', 'studyFirstSubmitQcDate': '2013-01-16', 'lastUpdatePostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of newly-formed bone', 'timeFrame': '6 months after surgical intervention', 'description': 'The histomorphometrical analysis of the biopsies taken after 6 months of surgical intervention (time for dental implants insertion) will be performed to calculate the primary outcome'}], 'secondaryOutcomes': [{'measure': 'Bone density', 'timeFrame': 'at baseline and after 6 months of intervention', 'description': 'This data will be measured on the cone-beam CT scanners obtained at baseline and after 6 months of healing'}, {'measure': 'Insertion torque', 'timeFrame': '6 months after surgical intervention', 'description': 'At the time of implant insertion and initial insertion torque will be registered'}, {'measure': 'Percentage of residual graft', 'timeFrame': '6 months after surgical intervention', 'description': 'The histological analysis will determine the percentage of residual graft after 6 months of surgery.'}, {'measure': 'Pain index', 'timeFrame': '7 days, 15 days, 1 month, 2 months, 6 months and 12 months after surgical intervention', 'description': 'This will evaluate the intensity of pain the patient suffered due to the surgical intervention.'}, {'measure': 'Healing index', 'timeFrame': '7 days, 15 days and 1 month after surgical intervention', 'description': 'This index will evaluate the soft tissue healing.'}, {'measure': 'Infection', 'timeFrame': '7 days, 15 days, 1 month, 2 months, 6 months and 12 months after surgical intervention', 'description': 'Notify the infection of the graft material'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PRGF-Endoret', 'Bone graft', 'Maxillary sinus', 'Vertical bone augmentation'], 'conditions': ['Sinus Floor Augmentation']}, 'descriptionModule': {'briefSummary': 'This randomized clinical study investigates the efficiency of plasma rich in growth factors (PRGF-Endoret) in combination with bone grafts in the healing of bone and soft tissues after the performance of lateral sinus floor elevation.\n\nThe hypothesis of this study is that the use of PRGF-Endoret will produce similar bone formation regardless the type of bone graft.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years\n* Patients requiring implant prostheses oral rehabilitation.\n* Patients with insufficient residual height in posterior maxilla requiring a sinus lift procedure to insert the implants\n\nExclusion Criteria:\n\n* Not having complete the informed consent form.\n* Sinusitis.\n* Alcoholism.\n* Suffering severe haematological disorder or disease.\n* Be undergoing or having received radiotherapy, chemotherapy or immunosuppressive therapy, corticosteroids and / or anticoagulants, 30 days prior to the study inclusion.\n* In usual treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or other anti-inflammatory drugs.\n* Background of chronic hepatitis or liver cirrhosis.\n* Diabetes mellitus with poor metabolic control (glycosylated hemoglobin above 9%)\n* Patients undergoing dialysis.\n* Presence of malignant tumors, hemangiomas or angiomas in the extraction area.\n* History of ischemic heart disease in the last year.\n* Pregnancy or intention to become pregnant during the study follow-up period.\n* Metabolic bone disease\n* Patients taking bisphosphonates drugs both orally and intravenously.\n* In general, any inability to participate in the study'}, 'identificationModule': {'nctId': 'NCT01771302', 'briefTitle': 'Efficiency of PRGF-Endoret in Combination With a Bone Graft in Lateral Sinus Floor Elevation', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Eduardo Anitua'}, 'officialTitle': 'Randomized Clinical Trial on the Efficiency of PRGF-Endoret in Combination With a Bone Graft in Lateral Sinus Floor Elevation', 'orgStudyIdInfo': {'id': 'BTI-EC/12/Biomat'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bio-Oss', 'description': 'the xenograft is of bovine origin where the organic phase has been eliminated.', 'interventionNames': ['Device: Bio-Oss']}, {'type': 'EXPERIMENTAL', 'label': 'calcium phosphate ceramic', 'description': 'is a calcium phosphate biomaterial', 'interventionNames': ['Device: calcium phosphate ceramic']}], 'interventions': [{'name': 'Bio-Oss', 'type': 'DEVICE', 'description': 'It is a bone substitute of bovine origin', 'armGroupLabels': ['Bio-Oss']}, {'name': 'calcium phosphate ceramic', 'type': 'DEVICE', 'description': 'It is a synthetic bone substitute ceramic that is composed of calcium and phosphate ions and prepared at high temperature', 'armGroupLabels': ['calcium phosphate ceramic']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vitoria-Gasteiz', 'country': 'Spain', 'facility': 'Clinica Eduardo Anitua', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}], 'overallOfficials': [{'name': 'Eduardo Anitua, MD, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinica Eduardo Anitua'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Eduardo Anitua', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biotechnology Institute IMASD', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}