Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2025-12-24 @ 4:09 PM
Study NCT ID:
NCT04367766
Status:
RECRUITING
Last Update Posted:
2023-12-12
First Post:
2020-04-25
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Management of the Fresh Extraction Socket in the Aesthetic Area
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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-06', 'studyFirstSubmitDate': '2020-04-25', 'studyFirstSubmitQcDate': '2020-04-28', 'lastUpdatePostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient Reported Outcome Measurements', 'timeFrame': 'crown delivery, 1, 3, 5 years post loading', 'description': "Patient's satisfaction with the final result will be assessed by means of a 100 mm VAS scale ranging from 0 (no satisfaction) to 100 (best possible satisfaction), recording patient's experience"}, {'measure': 'Clinical parameters: Probing Depth (PD) and Recession (REC)', 'timeFrame': 'crown delivery, 1, 3, 5 years post loading', 'description': 'Probing Depth (PD) and Recession (REC) will be recorded in mm. with a periodontal probe (P-UNC 15, Hu Friedy) inserted with a standardised pressure into the peri-implant sulcus at 6 sites per implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual)'}, {'measure': 'Clinical parameters: Bleeding on Probing (BoP)', 'timeFrame': 'crown delivery, 1, 3, 5 years post loading', 'description': 'Bleeding on Probing (BoP) will be recorded as presence/absence with a periodontal probe (P-UNC 15, Hu Friedy) inserted with a standardised pressure into the peri-implant sulcus at 6 sites per implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual)'}, {'measure': 'Marginal Bone Level (MBL)', 'timeFrame': 'crown delivery, 1, 3, 5 years post loading', 'description': 'Marginal Bone Level (MBL) will be evaluated by a blinded examiner analysing an intra-oral radiograph on a computer software (Image J), as the distance in mm. between the smooth-rough interface and the mesial and distal bone level. The radiographs will be performed using a customized PVS bite block and an alignment device'}, {'measure': 'Aesthetic', 'timeFrame': 'crown delivery, 1, 3, 5 years post loading', 'description': 'Aesthetic will be evaluated by a blinded examiner analysing pictures using the modified pink and white aesthetic score (PES/WES system, Belser et al. 2009) and giving a score from 0 to 20.'}, {'measure': 'Volumetric bone and soft tissue changes', 'timeFrame': 'before tooth extraction, 4 months after tooth extraction, at prosthetic crown delivery and 1, 3 and 5 year after crown delivery.', 'description': 'Volumetric bone change will be assessed by a blinded examiner analysing on a computer software (SMOP) DICOM files from cone-beam computed tomography (CBCT) scan. Contour soft tissue change and buccal soft tissue volume will be assessed by a blinded examiner analysing on a computer software (SMOP) STL files from digital impression. Dynamic Soft tissue healing will be assessed by a blinded examiner analysing superimposition on a computer software (SMOP) of DICOM files (from CBCT) and STL files (from digital impression)'}], 'primaryOutcomes': [{'measure': 'Rate of adjunctive bone and soft tissue augmentation procedures need.', 'timeFrame': 'during implant placement', 'description': 'Number of participants with the need for adjunctive reconstructive hard tissue procedure during implant placement will be evaluated as a frequency (Yes/No) after a digital prosthetically driven implant placement. The need for soft tissue augmentation during implant placement will be evaluated as a frequency (Yes/No) by a blinded examiner in case of buccal soft tissue thickness \\< 2mm assessed at 3mm apical to the full thickness flap margin with a caliber.'}], 'secondaryOutcomes': [{'measure': 'Peri-Implant Health', 'timeFrame': '1, 3, 5 years post loading', 'description': 'Peri-implant health will be assessed as a frequency (Yes/No) at 1, 3, 5 years after prosthetic crown delivery by a blinded examiner in case of: absence of clinical signs of inflammation, absence of bleeding and/or suppuration on gentle probing, no increase in probing depth compared to previous examinations, absence of bone loss beyond crestal bone level changes resulting from initial bone remodeling'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immediate implant placement', 'alveolar ridge preservation', 'delayed implant placement', 'PROMs', 'implant health', 'volumetric analysis', 'tissue augmentation'], 'conditions': ['Tooth Extraction Status Nos', 'Dental Implant', 'Bone Augmentation', 'Soft Tissue Augmentation']}, 'referencesModule': {'references': [{'pmid': '31215112', 'type': 'BACKGROUND', 'citation': 'Tonetti MS, Jung RE, Avila-Ortiz G, Blanco J, Cosyn J, Fickl S, Figuero E, Goldstein M, Graziani F, Madianos P, Molina A, Nart J, Salvi GE, Sanz-Martin I, Thoma D, Van Assche N, Vignoletti F. Management of the extraction socket and timing of implant placement: Consensus report and clinical recommendations of group 3 of the XV European Workshop in Periodontology. J Clin Periodontol. 2019 Jun;46 Suppl 21:183-194. doi: 10.1111/jcpe.13131.'}, {'pmid': '31050359', 'type': 'BACKGROUND', 'citation': 'Clementini M, Agostinelli A, Castelluzzo W, Cugnata F, Vignoletti F, De Sanctis M. The effect of immediate implant placement on alveolar ridge preservation compared to spontaneous healing after tooth extraction: Radiographic results of a randomized controlled clinical trial. J Clin Periodontol. 2019 Jul;46(7):776-786. doi: 10.1111/jcpe.13125. Epub 2019 May 31.'}]}, 'descriptionModule': {'briefSummary': 'After atraumatic tooth extraction and the assessment of the feasibility of immediate implant placement, patients will be randomly assigned to one of three treatment concepts:\n\n1. Immediate Implant Placement and Immediate Provisionalization\n2. Alveolar Ridge Preservation. After 4 months of healing an implant will be placed with simultaneous GBR and/or Soft Tissue Augmentation procedures, if needed.\n3. Spontaneous Healing of the socket. After 4 months of healing, an implant will be placedwith simultaneous GBR and/or Soft Tissue Augmentation procedures, if needed.\n\nIn all groups, four months after implant placement, a prosthesis will be delivered. From this experimental period onward, patients will be scheduled for maintenance. Clinical, radiographic and volumetric assessment will be performed by clinicians not involved in the surgery and blind with respect to treatment assignment at 1, 3 and 5 years post loading.', 'detailedDescription': 'The overall objective of this study will be to compare the three treatment modalities after tooth extraction (immediate implant placement, alveolar ridge preservation, spontaneous healing) in terms of:\n\n* patient-related (morbidity) outcomes during surgical procedure and the first 2 weeks after the surgical procedure\n* cost-effectiveness ratio (treatment time, number of surgeries, number of appointments and overall appointments time, need for bone and soft tissue augmentation, overall costs) at the time of prosthesis delivery\n* volumetric bone and soft tissue changes of the site before treatment (prior to tooth extraction), 4 months after tooth extraction, 1, 3 and 5 years after final prosthesis.\n* clinical, radiographic, aesthetic and patient-related (satisfaction) outcomes at the time of prosthesis delivery and 1, 3 and 5 years after final prosthesis.\n* Implant Success and Survival at 1, 3 and 5 years after final prosthesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* single tooth extraction in the anterior region of the dentition (including premolars) to be extracted\n* smoking no more than 10 cigarettes/day,\n* periodontal health (BoP \\< 10%) and good plaque control (\\< 20%)\n* absence of symptomatic periapical radiolucencies, acute abscesses at the site of extraction,\n* extraction sites with less than 30% loss of one or more walls\n* adequate quantity and quality of native bone to achieve primary stability\n\nExclusion Criteria:\n\n* growing patients\n* patients with autoimmune disease, uncontrolled diabetes or immunocompromised\n* history of head and neck radiation for cancer treatment,\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT04367766', 'acronym': 'IIP/ARP/SH', 'briefTitle': 'Management of the Fresh Extraction Socket in the Aesthetic Area', 'organization': {'class': 'NETWORK', 'fullName': 'Centro Specialistico Odontoiatrico, Rome'}, 'officialTitle': 'Management of the Fresh Extraction Socket in the Aesthetic Area: Alveolar Ridge Preservation vs Immediate Implant Placement vs Delayed Implant Placement', 'orgStudyIdInfo': {'id': 'IIP/ARP/SH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Immediate Implant Placement', 'description': 'prosthetically driven immediate implant placement (TLC implant, Straumann) with bone substitute (BioOss Collagen, Geistlich) filling the gap between the buccal socket wall and the implant surface and a collagen matrix (Fibrogide, Geistlich) positioning at the vestibular aspect to increase soft tissue volume, with immediate (non occlusal loading) prosthetic provisionalization.', 'interventionNames': ['Procedure: Prosthetically driven implant placement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alveolar Ridge Preservation (ARP) + Delayed Implant Placement:', 'description': 'ARP performed with bone substitute (BioOss Collagen, Geistlich) and a collagen matrix placed to seal the socket entrance (Mucograft Seal, Geistlich). After 4 months of healing a prosthetically driven implant (TLC implant, Straumann) will be placed with adjunctive GBR procedure with bone substitute (BioOss Collagen, Geistlich) and a collagen membrane (BioGide, Geistlich) if buccal bone will be \\< 2 mm and soft tissue augmentation with a collagen matrix (Fibrogide, Geistlich) if soft tissue thickness will be \\< 2mm', 'interventionNames': ['Procedure: Prosthetically driven implant placement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Spontaneous Healing + Delayed Implant Placement', 'description': 'extraction socket will be left to heal spontaneously. After 4 months of healing a prosthetically driven implant (TLC implant, Straumann) will be placed with adjunctive GBR procedure with bone substitute (BioOss Collagen, Geistlich) and a collagen membrane (BioGide, Geistlich) if buccal bone will be \\< 2 mm, and soft tissue augmentation with a collagen matrix (Fibrogide, Geistlich) if soft tissue thickness will be \\< 2mm .', 'interventionNames': ['Procedure: Prosthetically driven implant placement']}], 'interventions': [{'name': 'Prosthetically driven implant placement', 'type': 'PROCEDURE', 'otherNames': ['Prosthetically driven implant installation'], 'description': 'Insertion of an osseointegrated implant into the bone of anterior maxilla/mandible, following the right prosthetic plan', 'armGroupLabels': ['Alveolar Ridge Preservation (ARP) + Delayed Implant Placement:', 'Immediate Implant Placement', 'Spontaneous Healing + Delayed Implant Placement']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marco Clementini, DDS, PhD', 'role': 'CONTACT', 'email': 'mclementini@me.com'}], 'facility': 'Centro Specialistico Odontoiatrico (CSO)', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Marco Clementini, DDS, PhD', 'role': 'CONTACT', 'email': 'mclementini@me.com', 'phone': '00393388378866'}], 'overallOfficials': [{'name': 'Marco Clementini, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro Specialistico Odontoiatrico, Rome'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'From the publication acceptance by the international peer-reviewed journal', 'ipdSharing': 'YES', 'description': 'all IPD that underlie results will be presented in open access publication in international peer-reviewed journal', 'accessCriteria': 'Open access publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Specialistico Odontoiatrico, Rome', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Fellow', 'investigatorFullName': 'Marco Clementini', 'investigatorAffiliation': 'Centro Specialistico Odontoiatrico, Rome'}}}}