Assessment of Digital and Clinical Workflow Using Patient Specific Sticky Bone /Implant Housing PEEK Shell in Anterior Atrophic Maxilla: A Case Series

Study Overview
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Brief Summary
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10 Patients having horizontally deficient anterior maxillary areas will be recruited and a preoperative CBCT will be done. The plan is to graft the defective ridges with simultaneously placing dental implants using a PEEK shell that will be specifically designed, constructed and 3D printed to act as a surgical guide for osteotomy drilling and implant placement as well as housing both the implant and the sticky bone (using a mixture of autogenous bone harvested from the symphysis area and xenograft both mixed with plasmatic matrix); that will be added to augment the defective ridge; the PEEK shell will also act as a barrier membrane for Guided Bone Regeneration and will add more stability to the placed implants that will be fixed to the PEEK shell occlusally with a Ti - based abutment. Primary stability will be measured using Ostell and an immediate postoperative CBCT will be done and superimposed on the preoperative CBCT and an accuracy of plan transfer will be measured to make sure the planning was followed accurately. Then 6 months later, another CBCT will be done to check the bone gain and quality and a second surgery will be done to remove the PEEK shell and proceed with the conventional implant prosthetic phase.

Official Title
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Assessment of Digital and Clinical Workflow Using Patient Specific Sticky Bone /Implant Housing PEEK Shell in Anterior Atrophic Maxilla: A Case Series

Conditions
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Ridge Augmentation

Intervention / Treatment
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* Procedure: sticky bone housed in PEEK Shell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Multiple missing Maxillary Anterior Teeth with horizontally defective ridges having adequate soft tissue ample. Patients who already gave their consent for this trial. Males and females both will be included. Exclusion Criteria: Patients on bisphosphonates or drugs altering bone metabolism, within 2 months before initiating the study. Subjected to irradiation in the head and neck region within the last year Patients allergic to drugs used in the study like ( Articaine, Lidocaine, Patients having a history of a major medical condition (ASA 3,4) Untreated periodontitis. Poor oral hygiene and motivation. Uncontrolled diabetes. Pregnant or nursing. Substance abuse. Psychiatric problems or unrealistic expectations. Severe bruxism or clenching. Immunosuppressed or immunocompromised. Treated or under treatment with intravenous amino-bisphosphonates. Active infection or severe inflammation in the area intended for implant placement. Unable to open mouth sufficiently to accommodate the surgical tooling. Patients participating in other studies, if the present protocol could not be properly followed. Referred only for implant placement or unable to attend a 5-year follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Other: Augmented group<br>Patient Specific Sticky Bone /Implant Housing PEEK Shell in Anterior Atrophic Maxilla with simultaneous implant placement | Procedure: sticky bone housed in PEEK Shell<br>* Patient specific Sticky Bone/Implant housing PEEK shell in Anterior Atrophic Maxilla<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone gain | Serial CBCT images (T0 before surgery, T1 immediately after surgery and T2 after 6 months) measuring bone gain in mm | T0 before surgery, T1 immediately after surgery and T2 after 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically successful osseointegrated implant | measuring primary stability immediately after implant placement and in the second surgery using Ostell device | At the day of the surgery and 6 months after first surgery | 
| Accuracy of Plan Transfer | superimposing the preoperative CBCT and the immediately postoperative CBCT to measure the accuracy of the procedure compared to the plan done | 1-3 days postoperatively | 
| Bone Quality | Serial CBCT images (T0 before surgery, T1 immediately after surgery and T2 after 6 months) measuring bone quality in Hounsfield units | 0 before surgery, T1 immediately after surgery and T2 after 6 months |