Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2026-03-21 @ 6:21 PM
Study NCT ID:
NCT02435706
Status:
COMPLETED
Last Update Posted:
2019-05-03
First Post:
2015-04-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Esthetic Outcomes of Single Immediate Implant Placement
Sponsor:
Organization:
Raw JSON
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'D014644', 'term': 'Genetic Variation'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D016296', 'term': 'Mutagenesis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ecs2181@cumc.columbia.edu', 'phone': '212-342-3008', 'title': 'Elena Sanz Miralles, DDS, PhD', 'organization': 'Columbia University College of Dental Medicine'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Flapless Group', 'description': 'Flapless immediate implant placement: Flapless placement of immediate implant and temporary crown\n\nFlapless immediate implant placement: No elevation of flap prior to immediate implant placement\n\nImplant and temporary crown: Standard intervention/procedure (non-experimental)\n\nPlease see attached publication', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Flap Group', 'description': 'Flap assisted immediate implant placement: Flap elevation prior to placement of immediate implant and temporary crown\n\nFlap assisted immediate implant placement: Flap will be elevated prior to immediate implant placement\n\nImplant and temporary crown: Standard intervention/procedure (non-experimental)', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 1, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Early implant failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flapless Group', 'description': 'Flapless immediate implant placement: Flapless placement of immediate implant and temporary crown\n\nFlapless immediate implant placement: No elevation of flap prior to immediate implant placement\n\nImplant and temporary crown: Standard intervention/procedure (non-experimental)\n\nPlease see attached publication'}, {'id': 'OG001', 'title': 'Flap Group', 'description': 'Flap assisted immediate implant placement: Flap elevation prior to placement of immediate implant and temporary crown\n\nFlap assisted immediate implant placement: Flap will be elevated prior to immediate implant placement\n\nImplant and temporary crown: Standard intervention/procedure (non-experimental)'}], 'classes': [{'title': 'From pre-operative to 3 months follow-up (Mesial)', 'categories': [{'measurements': [{'value': '.11', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '.43', 'spread': '.37', 'groupId': 'OG001'}]}]}, {'title': 'From pre-operative to 3 months follow-up (Buccal)', 'categories': [{'measurements': [{'value': '.28', 'spread': '.39', 'groupId': 'OG000'}, {'value': '.48', 'spread': '.50', 'groupId': 'OG001'}]}]}, {'title': 'From pre-operative to 3 months follow-up (Distal)', 'categories': [{'measurements': [{'value': '.11', 'spread': '.32', 'groupId': 'OG000'}, {'value': '.48', 'spread': '.44', 'groupId': 'OG001'}]}]}, {'title': 'From pre-operative to 6 months follow-up (Mesial)', 'categories': [{'measurements': [{'value': '.11', 'spread': '.32', 'groupId': 'OG000'}, {'value': '.40', 'spread': '.48', 'groupId': 'OG001'}]}]}, {'title': 'From pre-operative to 6 months follow-up (Buccal)', 'categories': [{'measurements': [{'value': '.19', 'spread': '.30', 'groupId': 'OG000'}, {'value': '.40', 'spread': '.60', 'groupId': 'OG001'}]}]}, {'title': 'From pre-operative to 6 months follow-up (Distal)', 'categories': [{'measurements': [{'value': '.14', 'spread': '.29', 'groupId': 'OG000'}, {'value': '.23', 'spread': '.47', 'groupId': 'OG001'}]}]}, {'title': 'From pre-operative to 12 months follow-up (Mesial)', 'categories': [{'measurements': [{'value': '.09', 'spread': '.27', 'groupId': 'OG000'}, {'value': '.22', 'spread': '.43', 'groupId': 'OG001'}]}]}, {'title': 'From pre-operative to 12 months follow-up (Buccal)', 'categories': [{'measurements': [{'value': '.22', 'spread': '.31', 'groupId': 'OG000'}, {'value': '.42', 'spread': '.52', 'groupId': 'OG001'}]}]}, {'title': 'From pre-operative to 12 months follow-up (Distal)', 'categories': [{'measurements': [{'value': '.06', 'spread': '.25', 'groupId': 'OG000'}, {'value': '.28', 'spread': '.39', 'groupId': 'OG001'}]}]}, {'title': 'From post-operative to 3 months (Mesial)', 'categories': [{'measurements': [{'value': '-.25', 'spread': '.46', 'groupId': 'OG000'}, {'value': '.10', 'spread': '.48', 'groupId': 'OG001'}]}]}, {'title': 'From post-operative to 3 months (Buccal)', 'categories': [{'measurements': [{'value': '-.22', 'spread': '.31', 'groupId': 'OG000'}, {'value': '.2', 'spread': '.62', 'groupId': 'OG001'}]}]}, {'title': 'From post-operative to 3 months (Distal)', 'categories': [{'measurements': [{'value': '-.31', 'spread': '.57', 'groupId': 'OG000'}, {'value': '0', 'spread': '.61', 'groupId': 'OG001'}]}]}, {'title': 'From post-operative to 6 months (Mesial)', 'categories': [{'measurements': [{'value': '-.50', 'spread': '.54', 'groupId': 'OG000'}, {'value': '-.05', 'spread': '.54', 'groupId': 'OG001'}]}]}, {'title': 'From post-operative to 6 months (Buccal)', 'categories': [{'measurements': [{'value': '-.25', 'spread': '.39', 'groupId': 'OG000'}, {'value': '.13', 'spread': '.60', 'groupId': 'OG001'}]}]}, {'title': 'From post-operative to 6 months (Distal)', 'categories': [{'measurements': [{'value': '-.25', 'spread': '.73', 'groupId': 'OG000'}, {'value': '-.03', 'spread': '.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Pre-operative Baseline in Gingival Margin Location at 3, 6 and 12 months and change from post-operative baseline at 3 and 6 months', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Buccal Horizontal Ridge Dimensions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flapless Group', 'description': 'Flapless immediate implant placement: Flapless placement of immediate implant and temporary crown\n\nFlapless immediate implant placement: No elevation of flap prior to immediate implant placement\n\nImplant and temporary crown: Standard intervention/procedure (non-experimental)\n\nPlease see attached publication'}, {'id': 'OG001', 'title': 'Flap Group', 'description': 'Flap assisted immediate implant placement: Flap elevation prior to placement of immediate implant and temporary crown\n\nFlap assisted immediate implant placement: Flap will be elevated prior to immediate implant placement\n\nImplant and temporary crown: Standard intervention/procedure (non-experimental)'}], 'classes': [{'title': 'Casts(Digital Over delays) 0-3 months', 'categories': [{'measurements': [{'value': '.64', 'spread': '.59', 'groupId': 'OG000'}, {'value': '.54', 'spread': '.63', 'groupId': 'OG001'}]}]}, {'title': 'Casts(Digital Over delays) 3-6 months', 'categories': [{'measurements': [{'value': '.18', 'spread': '.46', 'groupId': 'OG000'}, {'value': '.19', 'spread': '.7', 'groupId': 'OG001'}]}]}, {'title': 'Casts (stents) 0-3 months', 'categories': [{'measurements': [{'value': '.58', 'spread': '.60', 'groupId': 'OG000'}, {'value': '.80', 'spread': '.83', 'groupId': 'OG001'}]}]}, {'title': 'Casts (stents) 0-6 months', 'categories': [{'measurements': [{'value': '.89', 'spread': '.80', 'groupId': 'OG000'}, {'value': '.95', 'spread': '.92', 'groupId': 'OG001'}]}]}, {'title': 'Casts (stents) 0-12 months', 'categories': [{'measurements': [{'value': '.91', 'spread': '.84', 'groupId': 'OG000'}, {'value': '1.11', 'spread': '.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline in Buccal Horizontal Ridge Dimensions at 3, 6 and 12 months', 'description': 'Horizontal changes of the buccal ridge was calculated through the use of acrylic stents and digital overlays (3Shape D800, Biomet 3i, Palm Beach Gardens, FLS). The acrylic stents were obtained from the pre-surgical plaster casts and they were repositioned on the plaster casts obtained at 3, 6 and 12 months. Discrepancies between the acrylic stent and the plaster cast were measured with a probe. The digital cast overlays were used to analyze changes from pre-surgical to 3 and from 3 to 6 months). The plaster casts were scanned and changes were analyzed with the use of a software.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Interproximal Crestal Bone Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flapless Group', 'description': 'Flapless immediate implant placement: Flapless placement of immediate implant and temporary crown\n\nFlapless immediate implant placement: No elevation of flap prior to immediate implant placement\n\nImplant and temporary crown: Standard intervention/procedure (non-experimental)\n\nPlease see attached publication'}, {'id': 'OG001', 'title': 'Flap Group', 'description': 'Flap assisted immediate implant placement: Flap elevation prior to placement of immediate implant and temporary crown\n\nFlap assisted immediate implant placement: Flap will be elevated prior to immediate implant placement\n\nImplant and temporary crown: Standard intervention/procedure (non-experimental)'}], 'classes': [{'title': 'Bone level change at 6 months (mesial)', 'categories': [{'measurements': [{'value': '.31', 'spread': '.47', 'groupId': 'OG000'}, {'value': '.37', 'spread': '.91', 'groupId': 'OG001'}]}]}, {'title': 'Bone level change at 6 months (distal)', 'categories': [{'measurements': [{'value': '.45', 'spread': '.81', 'groupId': 'OG000'}, {'value': '.82', 'spread': '.87', 'groupId': 'OG001'}]}]}, {'title': 'Bone level change at 12 months (mesial)', 'categories': [{'measurements': [{'value': '.47', 'spread': '.98', 'groupId': 'OG000'}, {'value': '.73', 'spread': '1.18', 'groupId': 'OG001'}]}]}, {'title': 'Bone level change at 12 months (distal)', 'categories': [{'measurements': [{'value': '.59', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '1.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline in Interproximal Crestal Bone Levels at 6 and 12 months', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Flapless Group', 'description': 'Flapless immediate implant placement: Flapless placement of immediate implant and temporary crown\n\nFlapless immediate implant placement: No elevation of flap prior to immediate implant placement\n\nImplant and temporary crown: Standard intervention/procedure (non-experimental)\n\nPlease see attached publication'}, {'id': 'FG001', 'title': 'Flap Group', 'description': 'Flap assisted immediate implant placement: Flap elevation prior to placement of immediate implant and temporary crown\n\nFlap assisted immediate implant placement: Flap will be elevated prior to immediate implant placement\n\nImplant and temporary crown: Standard intervention/procedure (non-experimental)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Flapless Group', 'description': 'Flapless immediate implant placement: Flapless placement of immediate implant and temporary crown\n\nFlapless immediate implant placement: No elevation of flap prior to immediate implant placement\n\nImplant and temporary crown: Standard intervention/procedure (non-experimental)'}, {'id': 'BG001', 'title': 'Flap Group', 'description': 'Flap assisted immediate implant placement: Flap elevation prior to placement of immediate implant and temporary crown\n\nFlap assisted immediate implant placement: Flap will be elevated prior to immediate implant placement\n\nImplant and temporary crown: Standard intervention/procedure (non-experimental)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '85'}, {'value': '46', 'groupId': 'BG001', 'lowerLimit': '22', 'upperLimit': '73'}, {'value': '48', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '85'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-05-28', 'size': 131289, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-03-25T14:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2016-08-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-26', 'studyFirstSubmitDate': '2015-04-15', 'resultsFirstSubmitDate': '2019-03-25', 'studyFirstSubmitQcDate': '2015-05-01', 'lastUpdatePostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-26', 'studyFirstPostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline', 'timeFrame': 'Change from Pre-operative Baseline in Gingival Margin Location at 3, 6 and 12 months and change from post-operative baseline at 3 and 6 months'}], 'secondaryOutcomes': [{'measure': 'Change in Buccal Horizontal Ridge Dimensions', 'timeFrame': 'Change from Baseline in Buccal Horizontal Ridge Dimensions at 3, 6 and 12 months', 'description': 'Horizontal changes of the buccal ridge was calculated through the use of acrylic stents and digital overlays (3Shape D800, Biomet 3i, Palm Beach Gardens, FLS). The acrylic stents were obtained from the pre-surgical plaster casts and they were repositioned on the plaster casts obtained at 3, 6 and 12 months. Discrepancies between the acrylic stent and the plaster cast were measured with a probe. The digital cast overlays were used to analyze changes from pre-surgical to 3 and from 3 to 6 months). The plaster casts were scanned and changes were analyzed with the use of a software.'}, {'measure': 'Change in Interproximal Crestal Bone Levels', 'timeFrame': 'Change from Baseline in Interproximal Crestal Bone Levels at 6 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dental implants', 'surgical flap', 'esthetics', 'alveolar process'], 'conditions': ['Gingival Recession', 'Bone Loss, Alveolar']}, 'referencesModule': {'references': [{'pmid': '27501953', 'type': 'BACKGROUND', 'citation': 'Stoupel J, Lee CT, Glick J, Sanz-Miralles E, Chiuzan C, Papapanou PN. Immediate implant placement and provisionalization in the aesthetic zone using a flapless or a flap-involving approach: a randomized controlled trial. J Clin Periodontol. 2016 Dec;43(12):1171-1179. doi: 10.1111/jcpe.12610. Epub 2016 Oct 17.'}, {'pmid': '24894299', 'type': 'BACKGROUND', 'citation': 'Lee CT, Chiu TS, Chuang SK, Tarnow D, Stoupel J. Alterations of the bone dimension following immediate implant placement into extraction socket: systematic review and meta-analysis. J Clin Periodontol. 2014 Sep;41(9):914-26. doi: 10.1111/jcpe.12276. Epub 2014 Jul 23.'}]}, 'descriptionModule': {'briefSummary': 'A randomized controlled trial of 12-month duration to compare gingival margin location, buccal horizontal ridge dimensions, and interproximal crestal bone levels following two surgical approaches for immediate placement of implants in the esthetic zone: one involving flap elevation and another using a flapless protocol.', 'detailedDescription': 'In the test group, the implant will be placed according to standard protocol at a position engaging the palatal wall without elevation of a mucoperiosteal flap.\n\nIn the control group, intrasulcular incisions will be carried out from one tooth distal to one tooth mesial to the extraction site and full thickness flaps will be elevated with periosteal elevator, including the papillae. The implant will be placed according to standard protocol at a position engaging the palatal wall, and the flaps will be sutured using a combination of interrupted and mattress sutures.\n\nIn both groups, temporary restorations will be delivered immediately after implant placement provided that the implant shows primary stability and has engaged in the bone with an insertion torque of 25Ncm or more. In case of a lower insertion torque, the protocol will be abandoned, a cover screw will be placed, and a two stage implant protocol will be followed. All patients will be advised to receive a permanent restoration 6 months after surgery, if the implant is deemed to be successful.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Single non-restorable tooth in the anterior maxilla\n* Intact buccal plate or \\<5mm fenestration\n\nExclusion Criteria:\n\n* Pregnancy\n* Current smokers \\>10 cigarettes/day\n* Parafunctional habits\n* Malocclusion or intent of orthodontic therapy in the future\n* Severe periodontal disease'}, 'identificationModule': {'nctId': 'NCT02435706', 'briefTitle': 'Esthetic Outcomes of Single Immediate Implant Placement', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Esthetic Outcomes of Single Immediate Implant Placement With Immediate Restoration Performed With Two Surgical Techniques', 'orgStudyIdInfo': {'id': 'AAAI1840'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Flapless immediate implant placement group', 'description': 'Flapless placement of immediate implant and temporary crown', 'interventionNames': ['Procedure: Flapless immediate implant placement', 'Device: Implant and temporary crown']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Flap assisted immediate implant placement group', 'description': 'Flap elevation prior to placement of immediate implant and temporary crown', 'interventionNames': ['Procedure: Flap assisted immediate implant placement', 'Device: Implant and temporary crown']}], 'interventions': [{'name': 'Flapless immediate implant placement', 'type': 'PROCEDURE', 'description': 'Experimental group: No elevation of flap prior to immediate implant placement', 'armGroupLabels': ['Flapless immediate implant placement group']}, {'name': 'Flap assisted immediate implant placement', 'type': 'PROCEDURE', 'description': 'Control group: Flap will be elevated prior to immediate implant placement', 'armGroupLabels': ['Flap assisted immediate implant placement group']}, {'name': 'Implant and temporary crown', 'type': 'DEVICE', 'description': 'Both groups receive this intervention', 'armGroupLabels': ['Flap assisted immediate implant placement group', 'Flapless immediate implant placement group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Elena Sanz Miralles, DDS, MS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'timeFrame': 'April 2018. Data to be shared until the completion of the analysis of the data and publication of the results.', 'ipdSharing': 'YES', 'description': 'De-identified data were shared with The University of Texas Science Center at Houston (Dr. Chun-Teh Lee, formerly at Columbia University) in order to pursue further analysis of the data.', 'accessCriteria': 'De-identified data corresponding to clinical and radiographic measurements were shared. Data were shared with Dr. Chun-teh Lee, a former investigator of the study who is currently working at The University of Texas Science Center at Houston.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Dental Medicine (Periodontics)', 'investigatorFullName': 'Elena Sanz Miralles', 'investigatorAffiliation': 'Columbia University'}}}}