Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-28 @ 8:59 PM
Study NCT ID:
NCT03455361
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2018-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Bone Level Around Stark Conical Screw Implants With V-Blast Surface
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014095', 'term': 'Tooth, Impacted'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 293}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-27', 'studyFirstSubmitDate': '2018-02-16', 'studyFirstSubmitQcDate': '2018-02-27', 'lastUpdatePostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Osteointegration of V-Blast surface implant with low primary stability (<10 N/cm) after 4-6 months', 'timeFrame': '4 to 6 months', 'description': 'After 4-6 months, implant without good primary stability were evaluatd. A periapical radiograph was taken, a torque/countertorque test of 30 Ncm was conducted and osteointegrated implants were restored.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['implant stability, dental implants, primary stability'], 'conditions': ['Dental Impaction']}, 'descriptionModule': {'briefSummary': 'Clinical evaluation of osteointegration of bone level implants (Stark conical screw implants, with V-Blast surface treatment), placed without sufficient primary stability.', 'detailedDescription': '26 Implants were placed with a unique operative protocol in 4 private offices. A detailed informed consent was obtained from all patients. Surgical guides were used to achieve the idea implant position and axis.\n\nOsteotomy drills were used in the sequence recommended by the implant manufacturer. Bone type was assessed by CT examinations using the classification proposed by Rebaudi.\n\nAll implants were tested by applying a lateral mild load with a probe in order to verify mobility immediately after placement.\n\nParameter used to assess a low primary stability were:\n\n* insertion torque lower than 10 N / cm\n* slight mobility of implant upon application of lateral load of 250 g After surgery, patients were instructed not to chew or to wear their removable dentures in the treated areas.\n\nFollow-up post-operative visits were scheduled at 1 and 4 weeks. At 4-6 months after placement a periapical radiograph was taken, a torque/countertorque test of 30 Ncm was conducted and osteointegrated implants were restored. Patients were recalled, examined, and periapical radiographs were taken for a minimum of 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "the sample is composed by patients who had received Stark bone level V-Blast implants in 4 private offices in Italy. The same surgical protocol was used for all implants and a detailed informed consent was obtained from all patients, and included in their respective charts.\n\nFor the study objective were enrolled patient who didn't achieved primary stability at the placement: 26 patient", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient who had received Stark bone level V-Blast implants in 4 private offices in Italy\n* patient subscribed a detailed informed consent\n* same surgical protocol was applied\n\nExclusion Criteria:\n\n* patient without Stark implant'}, 'identificationModule': {'nctId': 'NCT03455361', 'acronym': 'STARKIMPLANT', 'briefTitle': 'Evaluation of Bone Level Around Stark Conical Screw Implants With V-Blast Surface', 'organization': {'class': 'OTHER', 'fullName': 'University of Milan'}, 'officialTitle': 'Clinical Osteointegration of Bone Level Implants With Conical Shape and Textured Surface With Low Primary Stability', 'orgStudyIdInfo': {'id': 'StarkImplant'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stark Implant with low primary stability', 'description': 'Patient who had received bone level V-Blast implants with low primary stability.', 'interventionNames': ['Procedure: Stark Implant with low primary stability']}, {'label': 'Stark Implant with primary stability', 'description': 'Patient who had received bone level V-Blast implants and achieved primary stability.', 'interventionNames': ['Procedure: Stark Implant with low primary stability']}], 'interventions': [{'name': 'Stark Implant with low primary stability', 'type': 'PROCEDURE', 'armGroupLabels': ['Stark Implant with low primary stability', 'Stark Implant with primary stability']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Giulio Rasperini, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Milan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Giulio Rasperini', 'investigatorAffiliation': 'University of Milan'}}}}