Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-02-25 @ 8:30 PM
Study NCT ID:
NCT03319758
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2021-02-09
First Post:
2017-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Esthetic and Radiographic Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall
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': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-08', 'studyFirstSubmitDate': '2017-09-14', 'studyFirstSubmitQcDate': '2017-10-23', 'lastUpdatePostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiographic bone volume', 'timeFrame': 'Up to 10 years after baseline', 'description': 'Radiographic bone volume be assessed at pre-operation, 0 ,0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.'}], 'secondaryOutcomes': [{'measure': 'Change of Pink and white esthetic scores (PES/WES)', 'timeFrame': 'Change from baseline up to 10 years after implantation', 'description': 'Baseline will be at the time of implant placement.Pink and white esthetic scores (PES/WES) will be recorded at 0.5, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.'}, {'measure': 'Visual analogue scale (VAS)', 'timeFrame': 'Up to 10 years after baseline', 'description': 'A questionnaire will be recorded at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement'}, {'measure': 'Oral health impact profile shortened version (OHIP-I)', 'timeFrame': 'Up to 10 years after baseline', 'description': 'A questionnaire will be recorded at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.'}, {'measure': 'Buccal marginal recession', 'timeFrame': 'Up to 10 years after baseline', 'description': 'Buccal marginal recession will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.'}, {'measure': 'Papilla volume', 'timeFrame': 'Up to 10 years after baseline', 'description': 'Papilla volume will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.'}, {'measure': 'Width of keratinized gingiva', 'timeFrame': 'Up to 10 years after baseline', 'description': 'Width of keratinized gingiva will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.'}, {'measure': 'Implant survival', 'timeFrame': 'Up to 10 years after baseline', 'description': 'Implant survival will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.'}, {'measure': 'Probing depth', 'timeFrame': 'Up to 10 years after baseline', 'description': 'Probing depth will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.'}, {'measure': 'Modified plaque index', 'timeFrame': 'Up to 10 years after baseline', 'description': 'Modified plaque index will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.'}, {'measure': 'Modified bleeding index', 'timeFrame': 'Up to 10 years after baseline', 'description': 'Modified bleeding index will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bone augmentation', 'esthetics', 'immediate implant', 'buccal bone defects'], 'conditions': ['Jaw, Edentulous, Partially', 'Acquired Absence of Single Tooth']}, 'referencesModule': {'references': [{'pmid': '25916859', 'type': 'RESULT', 'citation': 'Sarnachiaro GO, Chu SJ, Sarnachiaro E, Gotta SL, Tarnow DP. Immediate Implant Placement into Extraction Sockets with Labial Plate Dehiscence Defects: A Clinical Case Series. Clin Implant Dent Relat Res. 2016 Aug;18(4):821-9. doi: 10.1111/cid.12347. Epub 2015 Apr 27.'}, {'pmid': '24684275', 'type': 'RESULT', 'citation': 'Barone A, Ricci M, Romanos GE, Tonelli P, Alfonsi F, Covani U. Buccal bone deficiency in fresh extraction sockets: a prospective single cohort study. Clin Oral Implants Res. 2015 Jul;26(7):823-30. doi: 10.1111/clr.12369. Epub 2014 Mar 31.'}, {'pmid': '26330931', 'type': 'RESULT', 'citation': 'Aloy-Prosper A, Penarrocha-Oltra D, Penarrocha-Diago M, Penarrocha-Diago M. Dental implants with versus without peri-implant bone defects treated with guided bone regeneration. J Clin Exp Dent. 2015 Jul 1;7(3):e361-8. doi: 10.4317/jced.52292. eCollection 2015 Jul.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this prospective study was to evaluate the soft and hard tissue changes of immediate implant placement with buccal bone augmentation in sites with thin labial bone wall in the anterior maxillary zone.', 'detailedDescription': 'The objective of this prospective controlled clinical trial is to compare the esthetic and radiographic outcomes following immediate implant placement with thin or dehiscences buccal plate using bone augmentation in combination with an absorbable collagen membrane. Subjects in need of one implant replacing tooth to be removed in the maxilla within region 13-23 are included. At least 15 patients are recruited. No implant-supported temporary restorations are used during the first 4 months. After a screw-retained provisional phase of 2 months, a final impression is taken at implant level and take-in definitive crown. Patients are recalled for oral hygiene maintenance and prosthetic controls every 6 months for the entire duration of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'The inclusion criteria were as follows:\n\n1. 18 to 70-year-old;\n2. Stable periodontal and systemic health (American Society of Anesthesiologists classification I or II);\n3. Single maxillary anterior teeth (canine to canine);\n4. Bone thickness less than 1mm at 4mm apical to cementum-enamel junction (CEJ-4)；\n5. Presence of adjacent nature tooth;\n6. Good compliance;\n7. No palatal vertical bone loss;\n8. Good oral hygiene.\n\nExclusion criteria are as follow:\n\n1. Uncontrolled periodontal or systemic disease;\n2. General psychiatric contraindications;\n3. More than 20 cigarettes per day;\n4. History of head and neck radiotherapy；\n5. Pregnant or expecting to be pregnant;\n6. Patients with local or generalized healing limitations;\n7. Bruxism or other destructive parafunctional habits;\n8. Drug abuse or alcohol abuse.'}, 'identificationModule': {'nctId': 'NCT03319758', 'briefTitle': 'Esthetic and Radiographic Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Esthetic, Clinical and Patient-centered Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall in the Anterior Maxilla', 'orgStudyIdInfo': {'id': 'Baoxin Huang'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'thin or dehiscences buccal plate', 'description': 'Immediate implant placement used bone augmentation in combination with an absorbable collagen membrane with thin or dehiscences buccal plate.', 'interventionNames': ['Procedure: buccal bone augmentation']}], 'interventions': [{'name': 'buccal bone augmentation', 'type': 'PROCEDURE', 'description': 'Subjects in need of one implant replacing tooth to be removed in the maxilla within region 13-23 are included. At least 15 patients are recruited.', 'armGroupLabels': ['thin or dehiscences buccal plate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guanghua School of Stomatology,Hospital of Stomatology,Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Baoxin Huang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Baoxin Huang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}