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

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

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.

Study Overview

• Status: Completed
• Conditions: Bone Loss
• Intervention / Treatment: Device: PEEK framework

Detailed Description

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
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt, 54790
    • Khloud Ezzat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Khloud Ezzat, PhD, Lecturer of Prosthodontics

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2021
• Primary Completion (Actual): February 12, 2023
• Study Completion (Actual): March 20, 2023

Study Registration Dates

• First Submitted: August 5, 2023
• First Submitted That Met QC Criteria: August 27, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: CAD-CAM; All-on-Four implant; PEEK framework
• Other Study ID Numbers: A17100221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No