CAD-CAM PEEK Framework for All-on-4 Implants

Study Overview
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Brief Summary
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This study was conducted to evaluate the clinical peri-implant soft tissue changes during the first year after occlusal loading and the ridge base relation after 3 years for mandibular computer-aided design and computer-aided manufacturing (CAD/CAM) screw-retained implant-supported hybrid prosthesis of polyetheretherketone (PEEK) framework utilized with All-on-Four treatment concept.

Detailed Description
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Sixteen completely edentulous patients were rehabilitated by four implants following the All-on-Four protocol. After 3 months, the definitive prosthesis was constructed to be a screw-retained CAD-CAM milled framework from the modified PEEK (BioHPP), bonded to polymethylmethacrylate teeth and a pink-shaded indirect light-polymerized nano-filled composite resin imitating the soft tissues. Peri-implant soft tissue changes regarding plaque, bleeding, gingival scores, and probing depth were evaluated at prosthesis insertion (T0), 6 months (T1), and 12 months (T2) after insertion. Also, monitoring of the ridge base relation was performed using cone-beam computed tomography CBCT at the time of insertion (T0), and 1 year (T1), 2 years (T2), and 3 years (T3) after mandibular fixed detachable All-on-Four framework insertion.

Official Title
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Evaluation of Polyetheretherketone (PEEK) Framework Inserted in Multiunit Abutments of All-on-4 Concept for the Mandibular Edentulous Arch.

Conditions
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Bone Loss

Intervention / Treatment
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* Device: PEEK framework


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completely edentulous maxillary and mandibular ridges with sufficient mandibular bone height in the inter-foraminal area confirmed with panoramic x-rays. All selected patients will be with sufficient inter-arch space and restorative space. All selected patients will have apparently healthy ridge covered by compressible oral mucosa and free from any ridge flabbiness. Exclusion Criteria: Patients with systemic diseases that contraindicate implant placement such as hematologic diseases, serious problems of coagulation and diseases of the immune system. Also, metabolic diseases related to bone resorption such as uncontrolled diabetics or osteoporosis will be also excluded History of para-functional habits (Bruxism, clenching), smoking and alcoholism. History of radiation therapy in the head and neck region.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 70 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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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEEK group<br>Patients received PEEK framework prosthesis | Device: PEEK framework<br>* All-on-4 implants with PEEK framework of fixed detachable prosthesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of changes in the peri-implant soft tissue health | Peri-implant soft tissue changes regarding plaque scores were assessed using the modified plaque index | six months | 
| evaluation of changes in the peri-implant soft tissue health | Peri-implant soft tissue changes regarding bleeding scores were assessed using the bleeding index. | six months | 
| evaluation of changes in the peri-implant soft tissue health | Peri-implant soft tissue changes regarding the gingival scores were assessed using the simplified gingival index. | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ridge base relation monitoring | periodic monitoring of the changes in the alveolar ridge height in millimeters using CBCT | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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All-on-Four implant, CAD-CAM, PEEK framework