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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flapless immediate implant placement group | Experimental | Flapless placement of immediate implant and temporary crown |
|
| Flap assisted immediate implant placement group | Active Comparator | Flap elevation prior to placement of immediate implant and temporary crown |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flapless immediate implant placement | Procedure | Experimental group: No elevation of flap prior to immediate implant placement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Sanz Miralles, DDS, MS, PhD | Columbia University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27501953 | Background | 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. | |
| 24894299 | Background |
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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.
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April 2018. Data to be shared until the completion of the analysis of the data and publication of the results.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Flapless Group | Flapless immediate implant placement: Flapless placement of immediate implant and temporary crown Flapless immediate implant placement: No elevation of flap prior to immediate implant placement Implant and temporary crown: Standard intervention/procedure (non-experimental) Please see attached publication |
| FG001 | Flap Group | Flap assisted immediate implant placement: Flap elevation prior to placement of immediate implant and temporary crown Flap assisted immediate implant placement: Flap will be elevated prior to immediate implant placement Implant and temporary crown: Standard intervention/procedure (non-experimental) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Flapless Group | Flapless immediate implant placement: Flapless placement of immediate implant and temporary crown Flapless immediate implant placement: No elevation of flap prior to immediate implant placement Implant and temporary crown: Standard intervention/procedure (non-experimental) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | Posted | Mean | Standard Deviation | mm | 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 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Flapless Group | Flapless immediate implant placement: Flapless placement of immediate implant and temporary crown Flapless immediate implant placement: No elevation of flap prior to immediate implant placement Implant and temporary crown: Standard intervention/procedure (non-experimental) Please see attached publication |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Early implant failure | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elena Sanz Miralles, DDS, PhD | Columbia University College of Dental Medicine | 212-342-3008 | ecs2181@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 28, 2015 | Mar 25, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D016254 | Mutagenesis, Insertional |
| ID | Term |
|---|---|
| D015202 | Protein Engineering |
| D005818 | Genetic Engineering |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
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| Flap assisted immediate implant placement | Procedure | Control group: Flap will be elevated prior to immediate implant placement |
|
| Implant and temporary crown | Device | Both groups receive this intervention |
|
| Change from Baseline in Buccal Horizontal Ridge Dimensions at 3, 6 and 12 months |
| Change in Interproximal Crestal Bone Levels | Change from Baseline in Interproximal Crestal Bone Levels at 6 and 12 months |
| 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. |
| Flap Group |
Flap assisted immediate implant placement: Flap elevation prior to placement of immediate implant and temporary crown Flap assisted immediate implant placement: Flap will be elevated prior to immediate implant placement Implant and temporary crown: Standard intervention/procedure (non-experimental) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mm | Change from Baseline in Buccal Horizontal Ridge Dimensions at 3, 6 and 12 months |
|
|
|
| Secondary | Change in Interproximal Crestal Bone Levels | Posted | Mean | Standard Deviation | mm | Change from Baseline in Interproximal Crestal Bone Levels at 6 and 12 months |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Flap Group | Flap assisted immediate implant placement: Flap elevation prior to placement of immediate implant and temporary crown Flap assisted immediate implant placement: Flap will be elevated prior to immediate implant placement Implant and temporary crown: Standard intervention/procedure (non-experimental) | 0 | 21 | 0 | 21 | 1 | 21 |
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| D055093 |
| Periodontal Atrophy |
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009154 |
| Mutation |
| D014644 | Genetic Variation |
| D055614 | Genetic Phenomena |
| D016296 | Mutagenesis |
| Casts (stents) 0-3 months |
|
| Casts (stents) 0-6 months |
|
| Casts (stents) 0-12 months |
|
| Bone level change at 12 months (mesial) |
|
| Bone level change at 12 months (distal) |
|