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

Mansoura University16 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bone Loss

Interventions

PEEK frameworkDEVICE

All-on-4 implants with PEEK framework of fixed detachable prosthesis

Eligibility

Sex: ALLMin age: 60 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Khloud Ezzat

Al Mansurah, Egypt

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 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.

Time frame: six months

Secondary Outcomes

Ridge base relation monitoring

periodic monitoring of the changes in the alveolar ridge height in millimeters using CBCT

Time frame: 3 years

Data from ClinicalTrials.gov

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