(PEKK) Framework for Mandibular Implant-supported Complete Fixed Prostheses

Study Overview
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Brief Summary
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This clinical study aims to evaluate the effect of using PEKK (Pekkton) framework in mandibular implant-supported complete fixed dental prostheses with All-on-four treatment concept on peri-implant tissues health

Detailed Description
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The aim of this clinical study is to evaluate the effect of using PEKK (Pekkton) framework in mandibular implant-supported complete fixed dental prostheses with All-on-four treatment concept on peri-implant tissues health regarding the following parameters: Modified Plaque index Modified Gingival index Peri-implant probing pocket depth Radiographic evaluation (periapical x-ray): Marginal bone height changes

Official Title
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Polyether Ketone Ketone (PEKK) Framework for Mandibular Implant-supported Complete Fixed Dental Prostheses With All-on-four Treatment Concept Clinical and Radiographic Study

Conditions
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Bone Loss, Peri-Implantitis

Intervention / Treatment
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* Other: PEKK framework


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Maxillary and mandibular alveolar ridges were covered with healthy, firm, relatively even thickness and even compressible mucosa and free from any signs of inflammation or flabbiness. Patients had completely edentulous maxillary and mandibular ridges with sufficient mandibular bone height not less than 15 mm in the interforaminal area and at least 12mm posteriorly All patients had sufficient inter-arch space All patients complained of insufficient retention and stability of their conventional mandibular dentures. All patients were of Angel's class I maxillo-mandibular relationship. Exclusion Criteria: Patients with absolute contraindications for implant placement, such as active cancer and diseases of the immune system. Patients with metabolic diseases that are directly related to bone resorption, such as uncontrolled diabetes, osteoporosis, and hyperparathyroidism. Patients with general contraindications for surgical procedures, such as hematologic diseases, hepatic patients, patients with bleeding disorders, and serious problems with coagulation. Patients with a history of irradiation of the head and neck region or chemotherapy in the last 3 years were also excluded. Patients with relative contraindications such as a history of parafunctional habits (such as bruxism and clenching), smoking, alcoholism, and patients with any physical reasons that could affect follow-up. Patients with local contraindications for implant placement, such as localized bone defects.

Ages Eligible for Study
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Minimum Age: 50 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: PEKK (Pekkton) framework<br>PEKK (Pekkton) framework in mandibular implant-supported complete fixed dental prostheses with All-on-four treatment concept and evaluated regarding peri-implant tissue health | Other: PEKK framework<br>* PEKK (Pekkton) framework in mandibular implant-supported complete fixed dental prostheses with All-on-four treatment concept<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peri-implant tissues health (Clinical) | Modified gingival index | 1 year | 
| modified plaque index | peri-implant tissues health (Clinical) | 1 year | 
| peri-implant probing depth | Probing depth using plastic periodontal probe | 1 year | 
| Peri-implant radiographic evaluation | Marginal bone height changes using periapical radiograph | 1 year |