The Cortical Shield for Facial Bone Reconstruction

Study Overview
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Brief Summary
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To evaluate a novel technique of bone regeneration and simultaneous implant placement in severely damaged sockets.

Detailed Description
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Patients requiring a single implant, presenting severe facial bone loss as a result of previous infection, failed socket grafting or trauma, will enter this cross-sectional study. Socket reconstruction and simultaneous implant placement will be performed through periosteal-guided bone regeneration (PGBR). Implant timing: immediate or delayed. Implants will be encased in a customized shield of autogenous cortical bone harvested from an adjacent site. A re-entry surgery will be performed at 12-17-weeks to evaluate bone regeneration. Peri-implant tissues will be assessed following established success criteria. Implants will be evaluated for the presence of Periimplantitis.

Official Title
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The Cortical Shield for Facial Bone Reconstruction of Severely Damaged Sockets With Simultaneous Implant Placement

Conditions
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Tooth Loss, Tooth Diseases, Tooth Fracture, Tooth Injuries, Periodontal Bone Loss, Periodontitis, Peri-Implantitis, Tooth Decay

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA1 or ASA2 (American Society of Anesthesiologists) Healthy individuals with good oral hygiene and motivation No systemic uncontrolled diseases Not taking drugs known to modify bone metabolism Exclusion Criteria: Individuals with untreated & generalized severe periodontitis Heavy smokers (>10 cigarettes/day) Poor oral hygiene Diabetes (HbA1C >6.5% as cutoff value) Uncontrolled cardiovascular disease Poor overall health (ASA IV)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Immediate<br>implants are placed immediately after tooth extraction | |
| Delayed<br>implants are placed months after the tooth has been extracted | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individuals presenting alveolar Facial Bone regeneration at re-entry | Bone regeneration of the dent-alveolar socket | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pink Esthetic Scores | Scores 1-10: the higher the score the better the esthetic outcome. Evaluates soft tissue esthetics around the regenerated bone & implant: mesial & distal papillae, curvature of facial mucosa, level of facial mucosa, root convexity/soft tissue color & texture | 1 year | 
| Facial implant transparency | Presence of implant transparency at 1 year follow-up: Yes/No | 1 year | 
| Band of Keratinized tissue | Evaluation of the presence of a band of keratinized tissue around the implant: > 2mm or < 2mm | 1 year | 
| Implant crestal bone loss | Radiographic evaluation of peri-implant marginal crestal bone loss | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tooth socket, bone grafting, bone regeneration, dental implant, osseointegration