Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2026-01-05 @ 11:54 AM
Study NCT ID:
NCT02775058
Status:
UNKNOWN
Last Update Posted:
2016-06-29
First Post:
2016-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CP009 SYNERGOSS PXX Observational
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009066', 'term': 'Mouth, Edentulous'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'vital bone specimen sampled during surgery for dental implant placement'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-28', 'studyFirstSubmitDate': '2016-03-24', 'studyFirstSubmitQcDate': '2016-05-12', 'lastUpdatePostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '• Bone Volume total (%BV)', 'timeFrame': '4-6 months', 'description': 'The specimen, extracted from the bone of the patient, will be evaluated to define the quantity of total bone volume as compared to the specimen volume'}, {'measure': '• graft Volume (%graft)', 'timeFrame': '4-6 months', 'description': 'The specimen, extracted from the bone of the patient, will be evaluated to define the quantity of residual, non absorbed graft volume as compared to the specimen volume'}, {'measure': '• vital bone (%VB).', 'timeFrame': '4-6 months', 'description': 'The specimen, extracted from the bone of the patient, will be evaluated to define the quantity of vital, new formed bone volume as compared to the specimen volume'}, {'measure': '• device radiologic density (in a qualitative scale ranging from 1 to 4)', 'timeFrame': '4-6 months', 'description': 'the radiological density is visually evaluated by the investigator'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Mouth, Edentulous']}, 'descriptionModule': {'briefSummary': 'The device under investigation is SYNERGOSS, a CE (European Community CE) marked device.\n\nSynergoss is a granulated bone graft intended for use in dental applications. It is composed of a ceramic composite of Hydroxihapatite and Tricalciumphosphate in granules, coated with a dedicated collagen coating (porcine origin), obtained by means of collagen crosslinking on the ceramic granule surface.\n\nThe purpose of the study is to confirm the foreseen efficacy and tolerability of SYNERGOSS, a synthetic dental graft coated with collagen. For this observational study, we will enroll patients that already received a surgical intervention for sinus augmentation/ socket preservation by means of SYNERGOSS to maintain and regenerate bone before installation of endosseous titanium implants to support a fixed prosthesis. Patients will be enrolled just before they receive the surgery for the installation of endosseous titanium implants, about 24 weeks after the first surgery for the implant of SYNERGOSS.\n\nThe primary hypothesis is to demonstrate that SYNERGOSS consistently obtains the foreseen clinical benefit as declared in the Technical File.\n\nThe secondary hypothesis is to demonstrate that SYNERGOSS side effects and risks match those declared in the Technical File.\n\nThe study design is a\n\n* National\n* Monocentric\n* Prospective: the participants are identified and then followed forward in time.\n* Observational: participants that have recently received the grafting with SYNERGIES as part of normal and foreseen clinical procedures are enrolled in the study when they receive surgery for titanium implant placement and observed over time, with no substantial intervention other than the foreseen clinical treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The subjects enrolled in this CI just received dental grafting and in any case will be subject to the same procedures foreseen for this CI for the dental implant surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Received in the past 16-24 weeks a bone graft for sinus lift or socket preservation with the ID\n\n * Capable of giving a valid informed consent\n * ASA 1, ASA 2\n * agrees to return for follow-up visits up to 2 years\n\nExclusion Criteria:\n\n* • Uncontrolled Diabetes\n\n * Patients with psychiatric diseases\n * Neoplasic, immunodepressive, renal or liver major illnesses\n * Local radiotherapy\n * Major bruxism or major differences in the maxilla or mandubilar area\n * Drug or alcohol abuse\n * Major bone metabolism disorders\n * Heavy smokers (more than 10/day)\n * bisphosphonate treatment of major ostheoporosys or bone neoplasia\n * Pregnant women\n * Sinus illnesses\n * Contraindications to implant supported prostheses\n * Patients ASA 3,ASA 4, ASA5\n * Surgical intervention contraindications'}, 'identificationModule': {'nctId': 'NCT02775058', 'briefTitle': 'CP009 SYNERGOSS PXX Observational', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nobil Bio Ricerche srl'}, 'officialTitle': 'Clinical Evaluation Protocol Post Market Follow Up Pavia CP009 SYNERGOSS PXX Observational', 'orgStudyIdInfo': {'id': 'CP009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients', 'description': 'The subjects enrolled in this CI just received dental grafting by the device under evaluation and in any case will be subject to the same procedures foreseen for this CI for the dental implant surgery.', 'interventionNames': ['Device: synergoss Pxx']}], 'interventions': [{'name': 'synergoss Pxx', 'type': 'DEVICE', 'description': 'dental grafting', 'armGroupLabels': ['patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'state': 'PV', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Ruggero Rodriguez y Baena', 'role': 'CONTACT', 'email': 'ruggero.rodriguez@unipv.it'}], 'facility': 'Policlinico S. Matteo - Pavia', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'centralContacts': [{'name': 'marco morra, dr', 'role': 'CONTACT', 'email': 'mmorra@nobilbio.it'}], 'overallOfficials': [{'name': 'Ruggero Rodriguez y Baena', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'POLICLINICO S. MATTEO - PAVIA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nobil Bio Ricerche srl', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}