Ignite Creation Date:
2025-12-26 @ 5:21 PM
Ignite Modification Date:
2025-12-29 @ 5:06 AM
Study NCT ID:
NCT03357406
Status:
COMPLETED
Last Update Posted:
2017-11-29
First Post:
2017-11-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conventional and Ultrasonic Implant Site Preparation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016301', 'term': 'Alveolar Bone Loss'}], 'ancestors': [{'id': 'D001862', 'term': 'Bone Resorption'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'treatment method is masked till the surgical procedure, during which, both surgeon and patient are informed'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Split mouth design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-28', 'studyFirstSubmitDate': '2017-11-23', 'studyFirstSubmitQcDate': '2017-11-28', 'lastUpdatePostDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'implant survival rate', 'timeFrame': 'two years after surgery', 'description': 'how many implant are present in mouth'}], 'secondaryOutcomes': [{'measure': 'implant success rate', 'timeFrame': 'two years after surgery', 'description': 'implant stable and fulfilling success criteria'}, {'measure': 'biomechanical complications', 'timeFrame': 'two years after surgery', 'description': 'every complication linked to the crown, implant abutment structure'}, {'measure': 'marginal bone loss', 'timeFrame': 'two years after surgery', 'description': 'radiographically assessed bone level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['implant', 'piezoelectric', 'drills', 'immediate loading'], 'conditions': ['Bone Atrophy, Alveolar']}, 'referencesModule': {'references': [{'pmid': '24396835', 'type': 'BACKGROUND', 'citation': 'Vercellotti T, Stacchi C, Russo C, Rebaudi A, Vincenzi G, Pratella U, Baldi D, Mozzati M, Monagheddu C, Sentineri R, Cuneo T, Di Alberti L, Carossa S, Schierano G. Ultrasonic implant site preparation using piezosurgery: a multicenter case series study analyzing 3,579 implants with a 1- to 3-year follow-up. Int J Periodontics Restorative Dent. 2014 Jan-Feb;34(1):11-8. doi: 10.11607/prd.1860.'}, {'pmid': '19160225', 'type': 'BACKGROUND', 'citation': 'Esposito M, Grusovin MG, Achille H, Coulthard P, Worthington HV. Interventions for replacing missing teeth: different times for loading dental implants. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD003878. doi: 10.1002/14651858.CD003878.pub4.'}, {'pmid': '21599832', 'type': 'BACKGROUND', 'citation': 'Khayat PG, Arnal HM, Tourbah BI, Sennerby L. Clinical outcome of dental implants placed with high insertion torques (up to 176 Ncm). Clin Implant Dent Relat Res. 2013 Apr;15(2):227-33. doi: 10.1111/j.1708-8208.2011.00351.x. Epub 2011 May 20.'}]}, 'descriptionModule': {'briefSummary': 'multi center study with randomized controlled trial design, split mouth', 'detailedDescription': 'The present study has been designed as a multicenter prospective randomized controlled trial design. Fifteen clinical centers will treat patients by inserting and immediately loading implants with two different surgical protocols. Each patient will receive two identical implants: after randomization, the test site will be prepared by ultrasonic microvibrations and the control site using twist drills. Both implants will be loaded with a provisional crown within 48 hours after surgery. For each inserted implant, collection of experimental parameters will be required up to 2 years after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nindications for two implant-supported single crowns with immediate loading in the upper or lower arch (in the incisor, canine or premolar area), based on accurate diagnosis and treatment planning; 2) implants can be in the same or in different quadrants; 3) implant sites must be performed in similar bone quality (i.e. both maxillary or mandibular); 4) the bone crest must be healed (at least three months elapsed after tooth loss); 5) presence of a residual bone crest with an adequate volume to allow the insertion of a 3.8x11.5 mm implant without any kind of regenerative procedure; 6) age of the patient \\>18 years; 7) patient willing and fully capable to comply with the study protocol; 8) written informed consent given;\n\nExclusion Criteria:\n\n1. acute myocardial infarction within the past 2 months;\n2. uncontrolled coagulation disorders;\n3. uncontrolled diabetes (HBA1c \\> 7.5%);\n4. radiotherapy to the head/neck district within the past 24 months;\n5. immunocompromised patient (HIV infection or chemotherapy within the past 5 years);\n6. present or past treatment with intravenous bisphosphonates;\n7. psychological or psychiatric problems;\n8. alcohol or drugs abuse Local exclusion criterion is the presence of uncontrolled or untreated periodontal disease (full mouth plaque score and full mouth bleeding score \\> 25%)'}, 'identificationModule': {'nctId': 'NCT03357406', 'acronym': 'PI-DRI', 'briefTitle': 'Conventional and Ultrasonic Implant Site Preparation', 'organization': {'class': 'OTHER', 'fullName': 'International Piezosurgery Academy'}, 'officialTitle': 'Immediate Loading After Conventional and Ultrasonic Implant Site Preparation: a Multicenter Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'piezo-drills'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'edentulism side 1', 'description': 'ultrasound implant site preparation', 'interventionNames': ['Procedure: ultrasound implant site preparation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'edentulism side 2', 'description': 'conventional implant site preparation', 'interventionNames': ['Procedure: conventional implant site preparation']}], 'interventions': [{'name': 'ultrasound implant site preparation', 'type': 'PROCEDURE', 'description': 'piezoelectric bone surgery will be used to create implant bone ostectomy', 'armGroupLabels': ['edentulism side 1']}, {'name': 'conventional implant site preparation', 'type': 'PROCEDURE', 'description': 'twist drills will be used to create implant bone ostectomy', 'armGroupLabels': ['edentulism side 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43100', 'city': 'Parma', 'country': 'Italy', 'facility': 'Piezosurgery Academy', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}], 'overallOfficials': [{'name': 'Claudio Stacchi, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Piezosurgery Academy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Piezosurgery Academy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President of International Piezosurgery Academy', 'investigatorFullName': 'Mr. Claudio Stacchi, DDS, MSc', 'investigatorAffiliation': 'International Piezosurgery Academy'}}}}