Peri-implant Soft Tissue Conditioning of Immediate Posterior Implants by CAD/CAM Socket Sealing Abutments

Study Overview
=================
Brief Summary
-----------------
One of the major challenges one clinician can face while performing immediate placement on posterior area, is the ability of obtaining a hermetic primary closure of the soft tissue. The use of socket sealing abutment may provide advantages in maintaining the existing soft tissue architecture, preserving crestal bone height and reducing the risk of premature loading of the immediate implant during healing

Detailed Description
-----------------
One of the major challenges one clinician can face while performing immediate placement on posterior area, is the ability of obtaining a hermetic primary closure of the soft tissue. This technical skill is nearly always combined with invasive surgical procedures and significant post op recovery (displacement of the muco-gingival line, periosteal releasing incision, flaps, sutures, membrane stabilization, …).the use of customized healing abutment may provide advantages in maintaining the existing soft tissue architecture, preserving crestal bone height and reducing the risk of premature loading of the immediate implant during healing. Moreover, customized healing abutment can passively accommodate the definitive prosthesis with minimal or no pressure placement preventing biological or mechanical trauma during the prosthetic phases. This may lead to better long-term tissue stability and avoid the pain perceived by the patients from compression of tissues in case of standard healing abutment. the primary aim of this randomized controlled clinical study is to clinically evaluate and compare the soft tissue outcomes of final immediate implant restorations placed in maxillary posterior sites that were conditioned by CAD/CAM fabricated socket sealing abutments versus standard healing abutments. The secondary aim of this study is to radiographically assess peri-implant bone level changes of the final immediate implant restorations placed in maxillary posterior sites for the two experimental groups.

Official Title
-----------------
Peri-implant Soft Tissue Conditioning of Immediate Posterior Implants by CAD/CAM Socket Sealing Abutments (A Randomized Controlled Clinical Trial)

Conditions
-----------------
the Main Focus of the Study is to Use Socket Sealing Abutment in Conditioning of the Soft Tissue After Immediate Implant Placement

Intervention / Treatment
-----------------
* Procedure: cad/cam socket sealing abutment
* Procedure: standard healing abutment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. The patients ≥18 years old. 2. Non-restorable maxillary posterior teeth with intact adjacent teeth. 3. Sufficient bone to insert a dental implant with a minimum length of 8 mm and at least 3.5 mm in diameter. 4. Type1 extraction socket according to Elian et al, 200742 (Labial bone plate and associated soft tissues are completely intact). 5. Sufficient mesio-distal, bucco-lingual, and inter-occlusal space for placement of the definite restoration. 6. Adequate oral hygiene (full mouth plaque score < 25% and full mouth bleeding score < 25%). 7. Patients capable of understanding and giving informed consent. Exclusion Criteria: 1. Alcohol or drug abusers. 2. Heavy smokers (> 10 cigarettes/day). 3. Presence of acute periapical infections. 4. Radiotherapy to the head and neck region for malignancy. 5. Bruxism or TMJ dysfunction. 6. Intake of drugs affecting bone metabolism. 7. Uncontrolled diabetic patients. 8. Pregnant women.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAD/CAM customized Socket Sealing Abutment<br>Anatomically formed healing abutments that can solve many of the problems inherent to immediate posterior implant placement and to optimize the conditioning of supra implant tissue architecture enhancing the emergence profile of the final implant restoration | Procedure: cad/cam socket sealing abutment<br>* Anatomically formed healing abutments that can solve many of the problems inherent to immediate posterior implant placement and to optimize the conditioning of supra implant tissue architecture enhancing the emergence profile of the final implant restoration<br>|
| Active Comparator: Standard healing abutment<br>Standard healing abutment will be inserted after removal of cover screw after immediate implant insertion and then a muco-periosteal flap will be reflected for the primary closure of the socket and sutured around the standard healing abutment. | Procedure: standard healing abutment<br>* Standard healing abutment will be inserted after removal of cover screw after immediate implant insertion and then a muco-periosteal flap will be reflected for the primary closure of the socket and sutured around the standard healing abutment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PES (pink esthetic score) | clinical evaluation of soft tissue profile around the implant restorations | one year of follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FIPS(Functional implant prosthodontic score) | clinical evaluation of implant restoration assembly and radiographic crestal bone loss | one year of follow up |