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

Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06017596
• Other study ID #: A17100221
• Status: Completed
• Phase: N/A
• Start date: February 23, 2021
• Est. completion date: March 20, 2023

Study information

• Verified date: July 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 20, 2023
• Est. primary completion date: February 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Loss

Intervention

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

Locations

Country	Name	City	State
Egypt	Khloud Ezzat	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Ridge base relation monitoring	periodic monitoring of the changes in the alveolar ridge height in millimeters using CBCT	3 years