Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT04345133
Status:
COMPLETED
Last Update Posted:
2020-04-14
First Post:
2020-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Undersized Drilling Upon the Immediate Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'No informaron about sequence of drilling was used to insert the implants'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Comparative'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2018-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-10', 'studyFirstSubmitDate': '2020-04-09', 'studyFirstSubmitQcDate': '2020-04-10', 'lastUpdatePostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insertion Torque', 'timeFrame': 'at baseline, through study completion in average 1 year', 'description': 'Maximum torque in N.cm obtained during insertion of the implant'}, {'measure': 'RFA Implant Stability', 'timeFrame': 'at baseline, through study completion in average 1 year', 'description': 'Implant Stability measure by Radio-Frequency Analysis.'}], 'secondaryOutcomes': [{'measure': 'RFA2 Implant Stability', 'timeFrame': '6 weeks after baseline, trough study completion in average 1 year', 'description': 'Implant Stability measure by Radio-Frequency Analysis 6 weeks later'}, {'measure': 'RFA3 Implant Stability', 'timeFrame': '12 weeks after baseline, trough study completion in average 1 year', 'description': 'Implant Stability measure by Radio-Frequency Analysis 12 weeks later'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary Stability', 'Secondary Stability', 'Undersized Drilling'], 'conditions': ['Implant Stability']}, 'referencesModule': {'references': [{'pmid': '27540846', 'type': 'BACKGROUND', 'citation': "Sierra-Rebolledo A, Allais-Leon M, Maurette-O'Brien P, Gay-Escoda C. Primary Apical Stability of Tapered Implants Through Reduction of Final Drilling Dimensions in Different Bone Density Models: A Biomechanical Study. Implant Dent. 2016 Dec;25(6):775-782. doi: 10.1097/ID.0000000000000479."}]}, 'descriptionModule': {'briefSummary': 'OBJECTIVE:\n\nevaluate the effect of undersized drilling upon the primary and secondary stability of immediate implants placed in the anterior sector maxilla.\n\nPATIENTS AND METHODS Study design A randomized comparative clinical trial was carried out. Thirty conical MIS C1 grade 23 titanium alloy (Ti 6Al 4V Eli) implants with a rough surface subjected to dual acid etching and sandblasting, measuring 3.75 mm in maximum diameter and 13 mm in length (MIS® Implants Technologies, Ltd. Bar Levi, Israel), were placed immediately after removal a anterior maxillary tooth in a series of patients treated in the clinic of the Master of Dentistry and Dental Implantology (Santa María University, Dental School, Caracas, Venezuela). The study was approved by the local Ethics Committee.\n\nPatient selection To enrolled in the study, patients had to comply the inclusion/exclusion criteria established to the study: over 18 years of age with indication of one or more immediate implants in the anterior maxilla; no history of ischemic heart disease, uncontrolled diabetes, coagulation disorders, head or neck radiotherapy, intravenous bisphosphonates or uncontrolled periodontal disease. Based on a CTCB evaluation, the teeth involved should have presence of bone ≥ 5 mm from the tooth apex to the lower cortical layer of the nasal fossa / maxillary sinus and no vertical defects greater than 4 mm at the buccal or palatine alveolar crest. Also, patients must have capacity to understand the study protocol and fill consent form to participation in the study.\n\nStudy procedure Two operators calibrated for immediate implant placement performed minimally traumatic tooth extraction following local infiltrating anesthesia with 4% articaine and 1:100,000 epinephrine (Artheek® 4%, New Stetic S.A.; Antioquia, Colombia). After evaluating the integrity of the bone walls, drilling sequence was established on a randomized basis.\n\nConventional drilling (CD) sequence:\n\n* Marking drill ∅1.9 mm at 1500 rpm\n* Pilot drill ∅ 2.4 mm and 13 mm in length at 800 rpm.\n* Twist drill ∅3 mm at 400 rpm.\n\nUndersized drilling (UD) sequence:\n\nMarking drill ∅1.9 mm at 1500 rpm Pilot drill ∅ 2.4 mm and 13 mm in length at 400 rpm. Implant insertion A surgical motor (MCU MIS, model M0132, W\\&H, Burmoos, Austria) with a 20:1 reducing implant handpiece was used to insert the implants at 20 rpm and applying a torque of 10 Ncm. Following placement of the implant in the bed, manual insertion was continued to reach the final implant position, established as 4 mm from the gingival margin.\n\nStudy variables Two torque meters (MIS® Implants LTD, models MT-RI040 and MT-RT070, Bar Levi, Israel) were used to insert and sequentially measure the maximum IT reached on positioning the implant in the socket. A Smart-peg Nro 49 model 100480 was fitted to the connection of each implant and an Osstell ISQ® (SN 4669 Osstell AB, Goteborg, Sweden) was used to perform RFA analysis and obtain corresponding ISQ value at insertion time (RFA1). A 4 mm height healing screw was used to seal the implant, and then additional RFA measurements was made at 6 week (RFA2) and 12 week (RFA3) post-implantation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nindication of one or more immediate implants in the anterior maxilla; No history of ischemic heart disease, No History of uncontrolled diabetes, No coagulation disorders, No head or neck radiotherapy\n\nExclusion Criteria:\n\nPeriodontal Disease. History of EV or Oral Bisphosphonate'}, 'identificationModule': {'nctId': 'NCT04345133', 'briefTitle': 'Effect of Undersized Drilling Upon the Immediate Implants', 'organization': {'class': 'OTHER', 'fullName': 'University of Carabobo'}, 'officialTitle': 'Effect of Undersized Drilling Upon the Primary and Secondary Stability of Immediate Conical Implants in the Esthetic Maxillary Sector', 'orgStudyIdInfo': {'id': 'UCarabobo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Undersized Drilling Group', 'description': 'Exposed patients to the reduction of the final drill dimensions at the insertion implants protocol sequence', 'interventionNames': ['Device: Dental Implants Insertion Drilling Sequence']}, {'type': 'OTHER', 'label': 'Conventional Drilling Group', 'description': 'Group with the conventional protocol recommended by the manufacturer', 'interventionNames': ['Device: Dental Implants Insertion Drilling Sequence']}], 'interventions': [{'name': 'Dental Implants Insertion Drilling Sequence', 'type': 'DEVICE', 'description': 'Drilling sequence protocol to insert immediate Dental Implants at the Maxilla.', 'armGroupLabels': ['Conventional Drilling Group', 'Undersized Drilling Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Alejandro Sierra-Rebolledo, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Carabobo, Faculty of Dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The study protocol is included in the medical records of the postgraduate degree and there are identity protection policies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Carabobo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Alejandro Sierra-Rebolledo', 'investigatorAffiliation': 'University of Carabobo'}}}}