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

M

Mansoura University

Status

Completed

Conditions

Bone Loss

Treatments

Device: PEEK framework

Study type

Interventional

Funder types

Other

Identifiers

NCT06017596
A17100221

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

60 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

16 participants in 1 patient group

PEEK group
Experimental group
Description:
Patients received PEEK framework prosthesis
Treatment:
Device: PEEK framework

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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