Esthetic Outcomes of Single Immediate Implant Placement
Primary Purpose
Gingival Recession, Bone Loss, Alveolar
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Flapless immediate implant placement
Flap assisted immediate implant placement
Implant and temporary crown
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession focused on measuring Dental implants, surgical flap, esthetics, alveolar process
Eligibility Criteria
Inclusion Criteria:
- Single non-restorable tooth in the anterior maxilla
- Intact buccal plate or <5mm fenestration
Exclusion Criteria:
- Pregnancy
- Current smokers >10 cigarettes/day
- Parafunctional habits
- Malocclusion or intent of orthodontic therapy in the future
- Severe periodontal disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Flapless immediate implant placement group
Flap assisted immediate implant placement group
Arm Description
Flapless placement of immediate implant and temporary crown
Flap elevation prior to placement of immediate implant and temporary crown
Outcomes
Primary Outcome Measures
Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline
Secondary Outcome Measures
Change in Buccal Horizontal Ridge Dimensions
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.
Change in Interproximal Crestal Bone Levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02435706
Brief Title
Esthetic Outcomes of Single Immediate Implant Placement
Official Title
Esthetic Outcomes of Single Immediate Implant Placement With Immediate Restoration Performed With Two Surgical Techniques
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
August 9, 2016 (Actual)
Study Completion Date
August 9, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
In 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.
In 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Bone Loss, Alveolar
Keywords
Dental implants, surgical flap, esthetics, alveolar process
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flapless immediate implant placement group
Arm Type
Experimental
Arm Description
Flapless placement of immediate implant and temporary crown
Arm Title
Flap assisted immediate implant placement group
Arm Type
Active Comparator
Arm Description
Flap elevation prior to placement of immediate implant and temporary crown
Intervention Type
Procedure
Intervention Name(s)
Flapless immediate implant placement
Intervention Description
Experimental group: No elevation of flap prior to immediate implant placement
Intervention Type
Procedure
Intervention Name(s)
Flap assisted immediate implant placement
Intervention Description
Control group: Flap will be elevated prior to immediate implant placement
Intervention Type
Device
Intervention Name(s)
Implant and temporary crown
Intervention Description
Both groups receive this intervention
Primary Outcome Measure Information:
Title
Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline
Time Frame
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
Secondary Outcome Measure Information:
Title
Change in Buccal Horizontal Ridge Dimensions
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.
Time Frame
Change from Baseline in Buccal Horizontal Ridge Dimensions at 3, 6 and 12 months
Title
Change in Interproximal Crestal Bone Levels
Time Frame
Change from Baseline in Interproximal Crestal Bone Levels at 6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Single non-restorable tooth in the anterior maxilla
Intact buccal plate or <5mm fenestration
Exclusion Criteria:
Pregnancy
Current smokers >10 cigarettes/day
Parafunctional habits
Malocclusion or intent of orthodontic therapy in the future
Severe periodontal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Sanz Miralles, DDS, MS, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan 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.
IPD Sharing Time Frame
April 2018. Data to be shared until the completion of the analysis of the data and publication of the results.
IPD Sharing Access Criteria
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.
Citations:
PubMed Identifier
27501953
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.
Results Reference
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PubMed Identifier
24894299
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.
Results Reference
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Esthetic Outcomes of Single Immediate Implant Placement
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