Ridge Augmentation Using Patient Specific PEEK Sheets vs. Autogenous Bone Shell Technique.

Study Overview
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Brief Summary
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Comparative study to assess the ability of the patient specific PEEK sheets in ridge augmentation with using mixed Autogenous/Xenogenic bone graft vs the Bone Shell Technique regarding the time, accuracy and donor site morbidity .

Detailed Description
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A- Intervention Group (Patient specific PEEK sheets) Preoperative Computed tomography will be done to the patients. Using special software, 3D models will be obtained and used to design the custom made PEEK sheets. The final STL (Standard Tessellation Language) files will be sent to the lab to be milled/printed. Autogenous bone graft will be taken from Chin/Retromolar graft and will be mixed with xenogenic bone graft in 1:1 ratio. After bone exposure, the ridge will be decorticated and the prefabricated PEEK sheets will be fixed with titanium screws and the space between the sheets and the ridge will be filled with the prepared bone graft. Wounds closure will be done. CT scan will be done postoperative. After 6 months another CT scan will be done for evaluation and comparison. Then the titanium screws will be removed and implants will be placed. B- Control Group (Autogenous bone shell technique) Preoperative Computed tomography will be done to the patients Bone graft will be harvested from the chin/retromolar region and a cortico- cancellous bone block will be obtained then divided into two pieces used as the shells. The bone shells will be trimmed and adjusted to the recipient site and the remaining bone will be milled and mixed with Xenogenic bone graft with ratio 1:1 The bone shells will be anchored in the host bone with titanium screws and the space between the shells and the alveolar bone will be filled by the bone graft mix. Wounds closure will be done. CT scan will be done. After 6 months another CT scan will be done for evaluation and comparison. Then the patient will go for micro screws removal along with implant placement.

Official Title
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3D Ridge Augmentation in the Anterior Maxillary Region Using Patient Specific Polyether Ether Ketone (PEEK) Sheets vs. Autogenous Bone Shell Technique. A Randomized Clinical Trial: Comparative Study

Conditions
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Ridge Deficiency

Intervention / Treatment
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* Procedure: Patient specific PEEK sheets
* Procedure: Autogenous bone shell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with deficient alveolar bone in the anterior maxilla. Patient seeking fixed prosthesis at the anterior maxillary region. Highly motivated patients. Good oral hygiene. Patients willing for the surgical procedure and follow-up, with an informed consent. Bounded anterior maxilla cases. Exclusion Criteria: Medically compromised patients. Uncooperative patients. Poor oral hygiene. Periodontal diseases. No history of any grafting procedure at the designated edentulous ridge.Criteria Patients with any diseases that compromise bone or soft tissue healing. Patients with no local pathosis that interfere with the bone healing.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized clinical trial. Parallel group study. A trial will be carried out in hospital of Oral and Maxillofacial surgery department - Faculty of Oral and Dental Medicine - Cairo University . Equal randomization : participants with equal probabilities for intervention. Positive controlled : Both groups receiving treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient specific PEEK sheets<br>Patient specific PEEK sheets will be fixed with titanium screws and act as containment system for the mixed autogenous/xenogenic bone graft that will fill the gap between the sheets and the ridge . | Procedure: Patient specific PEEK sheets<br>* Computer aided sheet design<br>|
| Active Comparator: Autogenous bone shell technique<br>Bone shells will be fixed with titanium screws to the ridge and mixed autogenous/xenogenic bone graft will fill the gap between the shells and the ridge . | Procedure: Autogenous bone shell<br>* autogenous retromolar/chin bone graft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Questionnaire will be used to evaluate the satisfaction , measuring unit Binary (YES/NO) | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone gain | Bone gain will be evaluated using the Computed tomography , measuring unit (mm) | 4-6 months post-operative | 
| Bone quality | Histological analysis of bone core biopsy , measuring unit Osteon number | 4-6 months post-operative | 
| Soft tissue reaction | Clinical evaluation by caliber to measure thickness of keratinized mucosa ,measuring unit (mm) | 4-6 months postoperative | 
| Intraoperative time | Using stop watch to measure the operative time | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior maxillary region, Patient specific, Autogenous bone shell, PEEK, Ridge augmentation