Skip to main content
Clinical Trials/NCT06017596
NCT06017596
Completed
N/A

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

Mansoura University1 site in 1 country16 target enrollmentFebruary 23, 2021
ConditionsBone Loss

Overview

Phase
N/A
Intervention
Not specified
Conditions
Bone Loss
Sponsor
Mansoura University
Enrollment
16
Locations
1
Primary Endpoint
evaluation of changes in the peri-implant soft tissue health
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 23, 2021
End Date
March 20, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

evaluation of changes in the peri-implant soft tissue health

Time Frame: six months

Peri-implant soft tissue changes regarding the gingival scores were assessed using the simplified gingival index.

Secondary Outcomes

  • Ridge base relation monitoring(3 years)

Study Sites (1)

Loading locations...

Similar Trials