The Vestibular Socket Therapy : A Novel Concept for Immediate Implant Placement in Defective Fresh Extraction Sites

Study Overview
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Brief Summary
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This article aims to provide a non- staged treatment protocol to placing dental implants in compromised fresh sockets in the aesthetic zone.

Detailed Description
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This is a site-specific therapy uses study a slowly resorbing regenerative barrier (shield) to augment any thin or deficient labial plate of bone, enhances the overlying soft tissue quality and quantity at the same time with implant fixture placement using a computer-guided surgical template.

Official Title
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The Vestibular Socket Therapy : A Novel Concept for Immediate Implant Placement in Defective Fresh Extraction Sites

Conditions
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Immediate Implants

Intervention / Treatment
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* Procedure: Non-staged vestibular fresh socket therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A hopeless single tooth in the maxillary anterior region Sufficient apical bone to allow adequate anchorage/primary stability of the implant had natural teeth present adjacent to the tooth being replaced Exclusion Criteria: Presence of acute infection Impossibility of reaching adequate implant primary stability in the native Smokers of > 10 cigarettes Antitumor chemotherapy or radiotherapy in the previous year

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: xenograft cortical flexible sheet<br>a-traumatic tooth removal , socket lavage and curettage, performing a vestibular access horizontal incision corresponding to the socket 3-4 mm apically from the muccogingival junction , a tunnel is then created from the socket office and extended apically till it connects with the vestibular access incision, a computer guided surgical template is then used to deliver the implant in its optimal position, a slowly resorbable membrane shield is then introduced through the tunnel and stabilized with a membrane tac , it is a sturdy fixable membrane barrier placed above the labial plate | Procedure: Non-staged vestibular fresh socket therapy<br>* a slowly resorbable membrane shield is placed above the labial plate of bone so that when the thin labial plate started its resorption process the shield remains till a complete gap fill occurred thus leading to a thicker labial plate of bone or it preserves the socket architecture until a complete bone fill occurred inside the socket<br>* Other names: osteoflex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiographic buccal bone thickness | preoperative and follow up CBCTs are superimposed on each other and buccal bone thickness is measure at 3 similar points on both CBCTs and then a mean is calculated | 6 months | 
| radiographic buccal bone height | preoperative and follow up CBCTs are superimposed on each other and buccal bone height is measured in relation to implant shoulder level | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| final esthetic outcome of soft tissue | Pink esthetic score. based on subjective assessment of mesial papilla, distal papilla, midfacial level, midfacial contour, alveolar process deficiency, soft tissue color and texture. each item is given a score between 0 and 2, where 0 is the worst and 2 is the best outcome. Then, a final score ranging between 0-14 is calculated | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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xenograft cortical flexible sheet, fresh extraction socket