Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-25 @ 9:52 PM
Study NCT ID:
NCT04299750
Status:
UNKNOWN
Last Update Posted:
2020-03-09
First Post:
2015-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of a Alveolar Ridge Preservation Technique on the Need of Performing Guided Bone Regeneration for Dental Implant Placement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014084', 'term': 'Tooth Avulsion'}], 'ancestors': [{'id': 'D018677', 'term': 'Tooth Injuries'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014081', 'term': 'Tooth Extraction'}], 'ancestors': [{'id': 'D019647', 'term': 'Oral Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-04', 'studyFirstSubmitDate': '2015-05-03', 'studyFirstSubmitQcDate': '2020-03-04', 'lastUpdatePostDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of implants ideally placed', 'timeFrame': '6 months', 'description': 'The main goal is to determine if alveolar ridge preservation affects optimal implant positioning. This is defined as the implant position allowing to fulfill the ideal prosthetic design of the crown to be restored.'}], 'secondaryOutcomes': [{'measure': 'Peri-implant bone variation', 'timeFrame': '6 months', 'description': 'Crestal bone levels (CBL): distances from the implant shoulder to the most coronal bone to implant contact measured on X-rays with a millimeter ruler to the nearest 0.5 mm. Two measurements will be taken for each implant: mesially and distally'}, {'measure': 'Ridge volume at 6 months after tooth extraction', 'timeFrame': '6 months', 'description': 'The comparison of baseline and control cone.beam computed tomography and of clinical data in test and control groups will allow to determine volumetric effects on bone and soft tissues of socket preservation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Socket preservation', 'Single implant', 'Tooth extraction'], 'conditions': ['Tooth Avulsion']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate how a socket preservation procedure may reduce the need of guided bone regeneration surgery after tooth extraction and facilitate the placement of a dental implant in the optimal, prosthetic-driven position.', 'detailedDescription': 'The main gol of the study is to assess the efficacy of a socket preservation procedure in reducing the need of additional surgeries in order to augment alveolar bone volume before placing a dental implant in optimal position. Bone volume at 6 months will be compared to initial volume in order to assess volume variations and how they affect the positioning of a prosthetically driven, implant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 18 years of age\n\n * at least one intercalate tooth to be extracted, with complete alveolus and no soft tissue recession;\n * adequate oral hygiene, i.e. plaque index score ≤10%;\n * mesial-distal width of inter-dental space ≥7 mm;\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) score ≥III\n* presence of active periodontitis, clinically diagnosed in presence of probing depths ≥4 mm and bleeding on probing\n* a history of radiotherapy to the head and neck region\n* presence of conditions requiring chronic use of antibiotics\n* medical conditions requiring prolonged use of steroids\n* history of leucocyte dysfunction\n* history of bleeding disorders\n* history of renal failure\n* patients with metabolic bone disorders\n* patients with uncontrolled endocrine disorders\n* disability affecting oral hygiene\n* alcohol or drug abuse\n* HIV infection\n* smoking \\>10 cigarettes a day or cigar equivalents\n* conditions or circumstances that would prevent completion of study participation\n* mucosal diseases\n* presence of osseous lesions\n* severe bruxing or clenching habits\n* persistent intraoral infections\n* compromised alveolus (dehiscence, etc)'}, 'identificationModule': {'nctId': 'NCT04299750', 'briefTitle': 'Impact of a Alveolar Ridge Preservation Technique on the Need of Performing Guided Bone Regeneration for Dental Implant Placement', 'organization': {'class': 'OTHER', 'fullName': 'University of Parma'}, 'officialTitle': 'Impact of Alveolar Ridge Preservation on Optimal Implant Placement', 'orgStudyIdInfo': {'id': 'sockpres-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alveolar Ridge Preservation', 'description': 'Patients in this arm will undergo atraumatic extraction of an hopeless tooth and a socket preservation procedure. Alveolar ridge preservation will be performed using a slow-resorption bone substitute and a collagen membrane that covers the graft.', 'interventionNames': ['Procedure: Tooth extraction and Alveolar ridge preservation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Natural healing', 'description': 'Patients in this arm will undergo atraumatic extraction of an hopeless tooth. The socket will follow natural healing.', 'interventionNames': ['Procedure: Tooth extraction']}], 'interventions': [{'name': 'Tooth extraction and Alveolar ridge preservation', 'type': 'PROCEDURE', 'otherNames': ['Socket preservation'], 'description': 'Tooth extraction and alveolar ridge preservation with deproteinized bovine bone mineral and a collagen matrix seal', 'armGroupLabels': ['Alveolar Ridge Preservation']}, {'name': 'Tooth extraction', 'type': 'PROCEDURE', 'otherNames': ['Socket natural healing'], 'description': 'Tooth extraction and socket natural healing', 'armGroupLabels': ['Natural healing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43126', 'city': 'Parma', 'state': 'PR', 'country': 'Italy', 'facility': 'Centro Universitario di Odontoiatria', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}], 'overallOfficials': [{'name': 'Guido Macaluso, MDS, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Parma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Simone Lumetti', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dentsply Sirona Implants and Consumables', 'class': 'INDUSTRY'}, {'name': 'Geistlich Pharma AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'DDS, PhD, MSc', 'investigatorFullName': 'Simone Lumetti', 'investigatorAffiliation': 'University of Parma'}}}}