Bone Loss, Alveolar, Gingival Recession
Conditions
Keywords
Dental implants, surgical flap, esthetics, alveolar process
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.
Interventions
PROCEDUREFlapless immediate implant placement
Experimental group: No elevation of flap prior to immediate implant placement
PROCEDUREFlap assisted immediate implant placement
Control group: Flap will be elevated prior to immediate implant placement
DEVICEImplant and temporary crown
Both groups receive this intervention
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Buccal Horizontal Ridge Dimensions | Change from Baseline in Buccal Horizontal Ridge Dimensions at 3, 6 and 12 months | 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 | Change from Baseline in Interproximal Crestal Bone Levels at 6 and 12 months | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 18 |
| 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) | 21 |
| Total | 39 |
Baseline characteristics
| Characteristic | Flap Group | Total | Flapless Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 9 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 30 Participants | 13 Participants |
| Age, Continuous | 46 years | 48 years | 54 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 21 participants | 39 participants | 18 participants |
| Sex: Female, Male Female | 15 Participants | 25 Participants | 10 Participants |
| Sex: Female, Male Male | 6 Participants | 14 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 21 |
| other Total, other adverse events | 0 / 18 | 1 / 21 |
| serious Total, serious adverse events | 0 / 18 | 0 / 21 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Flapless Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From pre-operative to 6 months follow-up (Mesial) | .11 mm | Standard Deviation 0.32 |
| Flapless Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From pre-operative to 12 months follow-up (Buccal) | .22 mm | Standard Deviation 0.31 |
| Flapless Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From pre-operative to 3 months follow-up (Mesial) | .11 mm | Standard Deviation 0.32 |
| Flapless Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From pre-operative to 12 months follow-up (Distal) | .06 mm | Standard Deviation 0.25 |
| Flapless Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From pre-operative to 6 months follow-up (Buccal) | .19 mm | Standard Deviation 0.3 |
| Flapless Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From post-operative to 3 months (Mesial) | -.25 mm | Standard Deviation 0.46 |
| Flapless Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From pre-operative to 3 months follow-up (Distal) | .11 mm | Standard Deviation 0.32 |
| Flapless Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From post-operative to 3 months (Buccal) | -.22 mm | Standard Deviation 0.31 |
| Flapless Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From pre-operative to 6 months follow-up (Distal) | .14 mm | Standard Deviation 0.29 |
| Flapless Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From post-operative to 3 months (Distal) | -.31 mm | Standard Deviation 0.57 |
| Flapless Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From pre-operative to 3 months follow-up (Buccal) | .28 mm | Standard Deviation 0.39 |
| Flapless Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From post-operative to 6 months (Mesial) | -.50 mm | Standard Deviation 0.54 |
| Flapless Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From pre-operative to 12 months follow-up (Mesial) | .09 mm | Standard Deviation 0.27 |
| Flapless Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From post-operative to 6 months (Distal) | -.25 mm | Standard Deviation 0.73 |
| Flapless Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From post-operative to 6 months (Buccal) | -.25 mm | Standard Deviation 0.39 |
| Flap Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From post-operative to 6 months (Distal) | -.03 mm | Standard Deviation 0.64 |
| Flap Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From post-operative to 6 months (Buccal) | .13 mm | Standard Deviation 0.6 |
| Flap Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From pre-operative to 3 months follow-up (Mesial) | .43 mm | Standard Deviation 0.37 |
| Flap Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From pre-operative to 3 months follow-up (Buccal) | .48 mm | Standard Deviation 0.5 |
| Flap Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From pre-operative to 3 months follow-up (Distal) | .48 mm | Standard Deviation 0.44 |
| Flap Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From pre-operative to 6 months follow-up (Mesial) | .40 mm | Standard Deviation 0.48 |
| Flap Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From pre-operative to 6 months follow-up (Buccal) | .40 mm | Standard Deviation 0.6 |
| Flap Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From pre-operative to 6 months follow-up (Distal) | .23 mm | Standard Deviation 0.47 |
| Flap Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From pre-operative to 12 months follow-up (Mesial) | .22 mm | Standard Deviation 0.43 |
| Flap Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From pre-operative to 12 months follow-up (Buccal) | .42 mm | Standard Deviation 0.52 |
| Flap Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From pre-operative to 12 months follow-up (Distal) | .28 mm | Standard Deviation 0.39 |
| Flap Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From post-operative to 3 months (Mesial) | .10 mm | Standard Deviation 0.48 |
| Flap Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From post-operative to 3 months (Buccal) | .2 mm | Standard Deviation 0.62 |
| Flap Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From post-operative to 3 months (Distal) | 0 mm | Standard Deviation 0.61 |
| Flap Group | Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline | From post-operative to 6 months (Mesial) | -.05 mm | Standard Deviation 0.54 |
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.
Time frame: Change from Baseline in Buccal Horizontal Ridge Dimensions at 3, 6 and 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Flapless Group | Change in Buccal Horizontal Ridge Dimensions | Casts(Digital Over delays) 3-6 months | .18 mm | Standard Deviation 0.46 |
| Flapless Group | Change in Buccal Horizontal Ridge Dimensions | Casts (stents) 0-6 months | .89 mm | Standard Deviation 0.8 |
| Flapless Group | Change in Buccal Horizontal Ridge Dimensions | Casts (stents) 0-3 months | .58 mm | Standard Deviation 0.6 |
| Flapless Group | Change in Buccal Horizontal Ridge Dimensions | Casts (stents) 0-12 months | .91 mm | Standard Deviation 0.84 |
| Flapless Group | Change in Buccal Horizontal Ridge Dimensions | Casts(Digital Over delays) 0-3 months | .64 mm | Standard Deviation 0.59 |
| Flap Group | Change in Buccal Horizontal Ridge Dimensions | Casts (stents) 0-12 months | 1.11 mm | Standard Deviation 0.92 |
| Flap Group | Change in Buccal Horizontal Ridge Dimensions | Casts(Digital Over delays) 0-3 months | .54 mm | Standard Deviation 0.63 |
| Flap Group | Change in Buccal Horizontal Ridge Dimensions | Casts(Digital Over delays) 3-6 months | .19 mm | Standard Deviation 0.7 |
| Flap Group | Change in Buccal Horizontal Ridge Dimensions | Casts (stents) 0-3 months | .80 mm | Standard Deviation 0.83 |
| Flap Group | Change in Buccal Horizontal Ridge Dimensions | Casts (stents) 0-6 months | .95 mm | Standard Deviation 0.92 |
Secondary
Change in Interproximal Crestal Bone Levels
Time frame: Change from Baseline in Interproximal Crestal Bone Levels at 6 and 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Flapless Group | Change in Interproximal Crestal Bone Levels | Bone level change at 6 months (mesial) | .31 mm | Standard Deviation 0.47 |
| Flapless Group | Change in Interproximal Crestal Bone Levels | Bone level change at 6 months (distal) | .45 mm | Standard Deviation 0.81 |
| Flapless Group | Change in Interproximal Crestal Bone Levels | Bone level change at 12 months (mesial) | .47 mm | Standard Deviation 0.98 |
| Flapless Group | Change in Interproximal Crestal Bone Levels | Bone level change at 12 months (distal) | .59 mm | Standard Deviation 1.05 |
| Flap Group | Change in Interproximal Crestal Bone Levels | Bone level change at 12 months (distal) | 1.33 mm | Standard Deviation 1.23 |
| Flap Group | Change in Interproximal Crestal Bone Levels | Bone level change at 6 months (mesial) | .37 mm | Standard Deviation 0.91 |
| Flap Group | Change in Interproximal Crestal Bone Levels | Bone level change at 12 months (mesial) | .73 mm | Standard Deviation 1.18 |
| Flap Group | Change in Interproximal Crestal Bone Levels | Bone level change at 6 months (distal) | .82 mm | Standard Deviation 0.87 |