Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-03-06 @ 6:29 AM
Study NCT ID:
NCT01746160
Status:
COMPLETED
Last Update Posted:
2022-08-05
First Post:
2012-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Follow-up After C1 Implant Stabilization Values
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007576', 'term': 'Jaw, Edentulous, Partially'}], 'ancestors': [{'id': 'D007575', 'term': 'Jaw, Edentulous'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009066', 'term': 'Mouth, Edentulous'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'open label'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-03', 'studyFirstSubmitDate': '2012-12-03', 'studyFirstSubmitQcDate': '2012-12-06', 'lastUpdatePostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Implant survival rate.', 'timeFrame': '90 days (At the end of the follow-up).', 'description': 'The rate of the implants found to be integrated at the end of the study (100% is anticipated).'}], 'primaryOutcomes': [{'measure': 'Change from baseline in implant ISQ value.', 'timeFrame': '90 days (at end of the follow-up).', 'description': "The change in implants' stability values that were measured by an 'Osstell' appliance at the end of the study as compared to their baseline value."}], 'secondaryOutcomes': [{'measure': 'Implant Marginal Bone Loss (MBL).', 'timeFrame': '90 days (At the end of the follow-up).', 'description': 'The amount of the marginal bone loss (MBL) as measured by comparing two intra-oral radiogram taken right after the operation and at the end of the follow-up period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dental implant', 'healing', 'implant stability'], 'conditions': ['Jaw, Edentulous, Partially']}, 'referencesModule': {'references': [{'pmid': '15355393', 'type': 'BACKGROUND', 'citation': 'Nedir R, Bischof M, Szmukler-Moncler S, Bernard JP, Samson J. Predicting osseointegration by means of implant primary stability. Clin Oral Implants Res. 2004 Oct;15(5):520-8. doi: 10.1111/j.1600-0501.2004.01059.x.'}, {'pmid': '15248877', 'type': 'BACKGROUND', 'citation': 'Glauser R, Sennerby L, Meredith N, Ree A, Lundgren A, Gottlow J, Hammerle CH. Resonance frequency analysis of implants subjected to immediate or early functional occlusal loading. Successful vs. failing implants. Clin Oral Implants Res. 2004 Aug;15(4):428-34. doi: 10.1111/j.1600-0501.2004.01036.x.'}, {'pmid': '16958688', 'type': 'BACKGROUND', 'citation': 'Turkyilmaz I, Sennerby L, Tumer C, Yenigul M, Avci M. Stability and marginal bone level measurements of unsplinted implants used for mandibular overdentures: a 1-year randomized prospective clinical study comparing early and conventional loading protocols. Clin Oral Implants Res. 2006 Oct;17(5):501-5. doi: 10.1111/j.1600-0501.2006.01261.x.'}, {'pmid': '16968381', 'type': 'BACKGROUND', 'citation': 'Hobkirk JA, Wiskott HW; Working Group 1. Biomechanical aspects of oral implants. Consensus report of Working Group 1. Clin Oral Implants Res. 2006 Oct;17 Suppl 2:52-4. doi: 10.1111/j.1600-0501.2006.01358.x.'}, {'pmid': '16968377', 'type': 'BACKGROUND', 'citation': 'Aparicio C, Lang NP, Rangert B. Validity and clinical significance of biomechanical testing of implant/bone interface. Clin Oral Implants Res. 2006 Oct;17 Suppl 2:2-7. doi: 10.1111/j.1600-0501.2006.01365.x.'}]}, 'descriptionModule': {'briefSummary': "The aim of the study is to describe the changes found in C1 dental implants through their early healing period.\n\nPatients requiring a standard installation of one or two implants in the maxilla, without any need for bone augmentation, will be frequently followed for 90 days. In every meeting the implants' ISQ values (values denoting the implant stability as being measured by a dedicated, commercially available, appliance called 'Osstell').\n\nThe implants' measured ISQ values will be used to describe the changes that may be found in the implants' stability through their healing period.\n\nAt the end of the study the patients will be referred to their treating doctor for the completion of implants' restoration (i.e. crown).", 'detailedDescription': "10 Patients requiring standard implant installation in their maxilla will be recruited to the study.\n\nInclusion criteria:\n\n* Men and women over the age of 18.\n* The patient will be willing, and will be available to attend all the follow-up meetings.\n* The patient will accept and sign an informed consent form before the beginning of the study.\n\nExclusion criteria:\n\n* Pregnant women or women who are breast feeding.\n* Patient suffering of untreated periodontal disease.\n* Patient who smoke more than 10 cigarettes per day.\n* Alcohol abuse.\n* Patient suffering of either uncontrolled Diabetes, Osteoporosis, rheumatic arthritis, neoplastic or pre-cancerous condition, or any other condition limiting standard implant installation procedure.\n* Patient who need some bone augmentation prior.\n* Immediate implant placement or restorations.\n\nCourse of study:\n\nEvery patient found eligible to the study will need to go through a CT scan of the implantation site (as required).\n\nBefore the operation 2 gr of AMOXICILLIN (or 600mg of CLYNDAMYCIN - in case of allergy) will be administered. The implants will be installed in a standard approach under local anesthesia, as customary being done. The implants' installation torque will be recorded.\n\nAt the end of the operation the patients will be instructed to rinse their mouth with Chlorhexidine solution for one week.\n\nEventually the implants will be restored and loaded after the common 3 months healing period.\n\nFollow-up appointments:\n\nThe patients will be monitored through a period of 3 months. The patients will be instructed to return to a follow-up examination 2, 4, 7, 14, 21, 28, 45, 60 and 90 days after the operation. On each meeting the implants' ISQ values will be measured using an 'Osstell' appliance.\n\nAn x-ray intra-oral radiogram will be taken right after the end of the operation and at the end of the follow-up (i.e day 90)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women over the age of 18.\n* The patient will be willing, and will be available to attend all the follow-up meetings.\n* The patient will accept and sign an informed consent form before the beginning of the study.\n\nExclusion criteria:\n\n* Pregnant women or women who are breast feeding.\n* Patient suffering of untreated periodontal disease.\n* Patient who smoke more than 10 cigarettes per day.\n* Alcohol abuse.\n* Patient suffering of either uncontrolled Diabetes, Osteoporosis, rheumatic arthritis, neoplastic or pre-cancerous condition, or any other condition limiting standard implant installation procedure.\n* Patient who need some bone augmentation prior.\n* Immediate implant placement or restorations.'}, 'identificationModule': {'nctId': 'NCT01746160', 'briefTitle': 'Longitudinal Follow-up After C1 Implant Stabilization Values', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'A Short-term Longitudinal Follow-up After C1 Implant Stability Values.', 'orgStudyIdInfo': {'id': 'C1implantstability-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'C1 Implant', 'description': 'Patient having C1 implant installed.', 'interventionNames': ['Drug: C1 Implant']}], 'interventions': [{'name': 'C1 Implant', 'type': 'DRUG', 'otherNames': ['Treated patients', 'Implant cases'], 'description': 'Patients treated with dental implants.', 'armGroupLabels': ['C1 Implant']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Hadas Lemberg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRB coorinator'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}