Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-24 @ 5:30 AM
Study NCT ID:
NCT02513368
Status:
COMPLETED
Last Update Posted:
2015-07-31
First Post:
2015-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peri Implant Soft Tissue Healing in Single Implant Restoration Using Two Different Techniques
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-29', 'studyFirstSubmitDate': '2015-07-03', 'studyFirstSubmitQcDate': '2015-07-29', 'lastUpdatePostDateStruct': {'date': '2015-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from baseline in the clinical characteristics of the peri implant mucosa', 'timeFrame': 'one month and one year after the placement of the definitive crowns', 'description': 'Buccal mucosa thickness was assessed with a calibrated endodontic file, 2 mm apical to the bone crest'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in probing pocket depth recorded at both mesial and distal tooth , adjacent to the implant site, by means of a periodontal probe', 'timeFrame': 'one month and one year after the placement of the definitive crowns'}, {'measure': 'change from baseline in height of keratinised tissue recorded at both mesial and distal tooth , adjacent to the implant site , by means of a periodontal probe', 'timeFrame': 'one month and one year after the placement of the definitive crowns'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['aesthetic', 'connective tissue graft', 'mucosa thickness'], 'conditions': ['Oral Soft Tissue Conditions']}, 'referencesModule': {'references': [{'pmid': '23347346', 'type': 'BACKGROUND', 'citation': 'Buser D, Chappuis V, Bornstein MM, Wittneben JG, Frei M, Belser UC. Long-term stability of contour augmentation with early implant placement following single tooth extraction in the esthetic zone: a prospective, cross-sectional study in 41 patients with a 5- to 9-year follow-up. J Periodontol. 2013 Nov;84(11):1517-27. doi: 10.1902/jop.2013.120635. Epub 2013 Jan 24.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study was to propose the employment of Bio-Oss® and Bio-Gide® at implant site in order to evaluate if the increased bucco-lingual bone thickness could enhance the stability of peri implant soft tissue, when compared to the grafting technique ( bilaminar technique), performed in association with implant placement .', 'detailedDescription': 'With respect to the soft tissue management many surgical approaches have been described in order to increase soft tissue volume and keratinized tissue height at implant site: roll flaps, connective tissue graft , epithelial connective tissue graft. In recent years, soft tissue substitutes , such as acellular dermal matrix or collagen matrix have been proposed to increase the dimensions of peri implant soft tissues; however, further studies have demonstrated that the allograft materials were less effective and less predictable than autogenous soft tissue grafts, in terms of increasing attached keratinized tissue , due to the considerable shrinkage and inconsistent quality of the attached tissue gained ; consequently soft tissue graft from the palate are currently considered the gold standard for augmenting peri implant soft. Some clinical studies proposed the association of contour augmentation by guided bone regeneration (GBR) with implant placement. The aim of these procedures is to restore the missing volume and to establish a facial bone wall of sufficient height and thickness to serve as a support for peri implant soft tissues; in these terms, GBR could be considered important to increase the stability of peri implant soft tissue , preventing the marginal soft tissue shrinkage and the following exposition of implant . This could be a valid approach to stabilize coronal peri implant soft tissue and at the same time less traumatic than grafting procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* one missing tooth in the anterior maxilla\n* facial keratinized mucosa thickness of at least 2mm\n\nExclusion Criteria:\n\n* heavy smokers\n* systemic diseases'}, 'identificationModule': {'nctId': 'NCT02513368', 'briefTitle': 'Peri Implant Soft Tissue Healing in Single Implant Restoration Using Two Different Techniques', 'organization': {'class': 'OTHER', 'fullName': 'University of Firenze and Siena, Napoli, Italy'}, 'officialTitle': 'Peri Implant Soft Tissue Healing in Single Implant Restoration Using the Guided Bone Regeneration Technique Ore a Connective Tissue Graft', 'orgStudyIdInfo': {'id': 'PHSIR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bio-Oss®, Bio-Gide®', 'description': 'augmentation procedure with Bio-Oss® and Bio-Gide®', 'interventionNames': ['Device: augmentation procedure with Bio-Oss® and Bio-Gide®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'connective tissue graft', 'description': 'augmentation procedure with connective tissue graft', 'interventionNames': ['Procedure: augmentation procedure with connective tissue graft']}], 'interventions': [{'name': 'augmentation procedure with Bio-Oss® and Bio-Gide®', 'type': 'DEVICE', 'description': 'soft tissue management using GBR procedure', 'armGroupLabels': ['Bio-Oss®, Bio-Gide®']}, {'name': 'augmentation procedure with connective tissue graft', 'type': 'PROCEDURE', 'description': 'soft tissue management using the bilaminar technique', 'armGroupLabels': ['connective tissue graft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53100', 'city': 'Siena', 'state': 'Siena', 'country': 'Italy', 'facility': 'Siena University, Department of Periodontology, Policlinico Le Scotte Siena.', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'zip': '53100', 'city': 'Siena', 'state': 'Siena', 'country': 'Italy', 'facility': 'Tuscan School of Dentistry', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}], 'overallOfficials': [{'name': 'massimo de sanctis, dentist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'school of dentale medicine , university of siena'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Firenze and Siena, Napoli, Italy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'oral surgeon', 'investigatorFullName': 'nicola baldini', 'investigatorAffiliation': 'University of Firenze and Siena, Napoli, Italy'}}}}