Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2026-02-23 @ 12:20 PM
Study NCT ID:
NCT03252106
Status:
COMPLETED
Last Update Posted:
2017-08-17
First Post:
2017-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Effectiveness of Contour Augmentation in Sites With Early Implant Placement
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'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-14', 'studyFirstSubmitDate': '2017-07-19', 'studyFirstSubmitQcDate': '2017-08-14', 'lastUpdatePostDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of contour augmentation', 'timeFrame': '10 year examination', 'description': 'Measurement of facial bone wall width with cone beam CTs (in mm)'}], 'secondaryOutcomes': [{'measure': 'Esthetic examination', 'timeFrame': '10 year examination', 'description': 'Pink Esthetic Score'}, {'measure': 'Peri-Implant soft tissue health', 'timeFrame': '10 year examination', 'description': 'Plaque Index'}, {'measure': 'Peri-implant bone loss over time', 'timeFrame': '10 year examination', 'description': 'Distance from the implant-shoulder to the first bone-to-implant-contact (DIB) in mm'}, {'measure': 'Peri-Implant soft tissue health', 'timeFrame': '10 year examination', 'description': 'Sulcus Bleeding Index'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Jaw, Edentulous, Partially', 'Dental Implants, Single-tooth', 'Grafting Bone']}, 'referencesModule': {'references': [{'pmid': '29073362', 'type': 'DERIVED', 'citation': 'Chappuis V, Rahman L, Buser R, Janner SFM, Belser UC, Buser D. Effectiveness of Contour Augmentation with Guided Bone Regeneration: 10-Year Results. J Dent Res. 2018 Mar;97(3):266-274. doi: 10.1177/0022034517737755. Epub 2017 Oct 26.'}]}, 'descriptionModule': {'briefSummary': 'In this prospective case series study, 20 patients with an implant-borne single crown following early implant placement with simultaneous contour augmentation will be followed for 10 years. Clinical, radiologic, and esthetic parameters will be assessed. In addition, cone beam computed tomography (CBCT) will be used at 10 years to examine the facial bone wall and compared to the 6 year data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Single tooth gaps post extraction in the esthetic zone\n* Written informed consent\n\nExclusion Criteria:\n\n* Heavy smoking (more than 10 cigarettes per day)'}, 'identificationModule': {'nctId': 'NCT03252106', 'briefTitle': 'Long-term Effectiveness of Contour Augmentation in Sites With Early Implant Placement', 'organization': {'class': 'OTHER', 'fullName': 'University of Bern'}, 'officialTitle': 'Long-term Effectiveness of Contour Augmentation in Sites With Early Implant Placement', 'orgStudyIdInfo': {'id': 'P004 Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Contour augmentation', 'interventionNames': ['Procedure: Contour augmentation with implant placement']}], 'interventions': [{'name': 'Contour augmentation with implant placement', 'type': 'PROCEDURE', 'description': 'Contour augmentation with implant placement', 'armGroupLabels': ['Contour augmentation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'University Hospital Inselspital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Daniel Buser, DMD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Bern'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}