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

Not Applicable

Completed

• Conditions: Bone Loss
• Interventions: Device: PEEK framework

• Registration Number: NCT06017596
• Lead Sponsor: Mansoura University

Brief Summary

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

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 Timeline

• Study Start: 2021-02-23
• Primary Completion: 2023-02-12
• Study Completion: 2023-03-20
• Status Verified: 2023-07
• Study First Submitted: 2023-08-05
• Study First Submitted QC: 2023-08-27
• Last Update Submitted: 2023-08-27
• Study First Posted: 2023-08-30
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEEK group	PEEK framework	Patients received PEEK framework prosthesis

Primary Outcome Measures

Name	Time	Method
evaluation of changes in the peri-implant soft tissue health	six months	Peri-implant soft tissue changes regarding the gingival scores were assessed using the simplified gingival index.

Secondary Outcome Measures

Name	Time	Method
Ridge base relation monitoring	3 years	periodic monitoring of the changes in the alveolar ridge height in millimeters using CBCT

Trial Locations

Locations (1)

Khloud Ezzat; 🇪🇬 Mansoura, Egypt