Esthetic Outcomes of Single Immediate Implant Placement

Study Overview
=================
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.

Official Title
-----------------
Esthetic Outcomes of Single Immediate Implant Placement With Immediate Restoration Performed With Two Surgical Techniques

Conditions
-----------------
Gingival Recession, Bone Loss, Alveolar

Intervention / Treatment
-----------------
* Procedure: Flapless immediate implant placement
* Procedure: Flap assisted immediate implant placement
* Device: Implant and temporary crown


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flapless immediate implant placement group<br>Flapless placement of immediate implant and temporary crown | Procedure: Flapless immediate implant placement<br>* Experimental group: No elevation of flap prior to immediate implant placement<br>Device: Implant and temporary crown<br>* Both groups receive this intervention<br>|
| Active Comparator: Flap assisted immediate implant placement group<br>Flap elevation prior to placement of immediate implant and temporary crown | Procedure: Flap assisted immediate implant placement<br>* Control group: Flap will be elevated prior to immediate implant placement<br>Device: Implant and temporary crown<br>* Both groups receive this intervention<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dental implants, surgical flap, esthetics, alveolar process