Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-02 @ 1:53 PM
Study NCT ID:
NCT05141851
Status:
COMPLETED
Last Update Posted:
2021-12-02
First Post:
2021-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Thread Length on Implant Stability
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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-01', 'studyFirstSubmitDate': '2021-11-20', 'studyFirstSubmitQcDate': '2021-12-01', 'lastUpdatePostDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'primary dental implant stability', 'timeFrame': 'On the 1 day of implants placement', 'description': 'measuring the ISQ value (implant stability quotient)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['implant stability; implant threads'], 'conditions': ['Implant Stability']}, 'descriptionModule': {'briefSummary': 'Some studies show that different types of threads in tapered implants result in differences in primary stability. The aim of this study is to a perform a prospective, controlled, randomized clinical trial comparing primary and secondary stability between long and standard thread implants in the treatment of partial edentulous patients.', 'detailedDescription': 'The study sample consists of 23 maxillary partial edentulous patients, where 32 implants were placed, with threads of 0.7 mm or 0.3 mm in the location of premolars and molars. The comparison, in terms of primary stability, is made by measuring the ISQ value (implant stability quotient), in four locations (buccal, palatal, mesial and distal). Statistical analysis was performed using the independent T-Test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimum 18 years;\n* No systemic conditions that contraindicate surgery;\n* Periodontal health or periodontal disease treated as part of a periodontal support program and having a high level of plaque control;\n* Partial edentulous patients, in the upper jaw, specifically in the location of premolars and molars;\n\nExclusion Criteria:\n\n* Patients with insufficient quantity of bone for implant placement without bone regeneration procedures;\n* Patients who underwent medication that could affect stability and osteointegration up to 3 months prior to study initiation;\n* Patients with untreated periodontal pathology or who have not followed periodontal supportive treatment;\n* Smokers, Pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT05141851', 'briefTitle': 'The Impact of Thread Length on Implant Stability', 'organization': {'class': 'OTHER', 'fullName': 'University of Lisbon'}, 'officialTitle': 'The Impact of Thread Length on Implant Stability', 'orgStudyIdInfo': {'id': 'The impact of thread length on'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Implants with 0,7mm threads', 'description': 'Placement of Implants with 0,7mm threads', 'interventionNames': ['Device: Implants with 0,7 mm threads']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Implants with 0,3mm threads', 'description': 'Placement of Implants with 0,3mm threads', 'interventionNames': ['Device: Implants with 0.3 mm threads']}], 'interventions': [{'name': 'Implants with 0,7 mm threads', 'type': 'DEVICE', 'description': 'Implants were placed, with threads of 0.7 mm in the location of premolars and molars.', 'armGroupLabels': ['Implants with 0,7mm threads']}, {'name': 'Implants with 0.3 mm threads', 'type': 'DEVICE', 'description': 'Implants were placed, with threads of 0.3 mm in the location of premolars and molars.', 'armGroupLabels': ['Implants with 0,3mm threads']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Vanessa Rodirgues', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}], 'overallOfficials': [{'name': 'Paulo Mascarenhas, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Lisbon'}, {'name': 'Susana Noronha, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Lisbon'}, {'name': 'Vanessa Rodrigues, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Lisbon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lisbon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vanessa Rocha Rodrigues', 'investigatorFullName': 'Vanessa Rocha Rodrigues', 'investigatorAffiliation': 'University of Lisbon'}}}}