Two Years Follow up of Polyetheretherketone (PEEK) Sub-periosteal Implant Retaining Maxillary Fixed Prosthesis

NCT05193110 | Completed

• 1 other identifier: A09091019
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial demonstrates prosthetic management of patients complained from lack of satisfaction and function of maxillary conventional complete denture as a result of severe maxillary ridge resorption seeking for fixed restoration. They were attended to the Department of Prosthodontics, Faculty of Dentistry, Mansoura University (Mansoura, Egypt). They demonstrated sever bone loss especially in the posterior region which complicate conventional implant placement for full arch prosthesis. Eight PEEK sub-periosteal implants were surgically placed. Probing depth was measured after three \& six months from sub-periosteal implant placement. Tumor necrosis factor-alpha (TNF-α) \& Interleukin-8(IL-8) Peri-abutment cervicular fluid were measured one month, three months , six months \& one year from sub-periosteal implant placement. Clinical \& Radiographic examination (CBCT) was done two years after sub-periosteal implant placement.

Conditions

Mastication Disorder

Keywords

Sub-periosteal implant; PEEK; CAD/CAM prosthesis; Maxilla

Outcome Measures

Primary Outcomes (1)

• Polyetheretherketone (PEEK) Sub-periosteal Implant Retaining Maxillary Fixed Prosthesis.

  PEEK sub-periosteal implants were surgically placed. Probing depth was measured after three \& six months from sub-periosteal implant placement. Tumor necrosis factor-alpha (TNF-α) \& Interleukin-8(IL-8) Peri-abutment cervicular fluid were measured one month, three months , six months \& one year from sub-periosteal implant placement.

  1 year

Study Arms (2)

CAD/CAM PEEK sub-periosteal implant retaining maxillary fixed prosthesis

OTHER

4 PEEK sub-periosteal implants were surgically placed for patients demonstrated sever bone loss especially in the posterior region which complicate conventional implant placement for full arch prosthesis.The PEEK framework was fabricated by CAD/CAM method

Other: Polyetheretherketone (PEEK) Sub-periosteal Implant Retaining Maxillary Fixed Prosthesis

Injection molding PEEK sub-periosteal implant retaining maxillary fixed prosthesis

OTHER

4 CAD/CAM PEEK sub-periosteal implants were surgically placed for patients demonstrated sever bone loss especially in the posterior region which complicate conventional implant placement for full arch prosthesis.The PEEK framework was fabricated by injection molding technique method.

Other: Polyetheretherketone (PEEK) Sub-periosteal Implant Retaining Maxillary Fixed Prosthesis

Interventions

Polyetheretherketone (PEEK) Sub-periosteal Implant Retaining Maxillary Fixed Prosthesis OTHER

Sub-periosteal Implant Retaining Maxillary Fixed Prosthesis fabricated by digital \& milling technology

CAD/CAM PEEK sub-periosteal implant retaining maxillary fixed prosthesis; Injection molding PEEK sub-periosteal implant retaining maxillary fixed prosthesis

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completely edentulous maxillary and mandibular arch..
• Residual ridge covered by sufficient thickness of mucosa 2-3 mm as verified by probing depth by using plastic probe.
• All patients with maxillary insufficient bone quantity (horizontal and vertical dimensions) and insufficient bone quality D5(Housefields Units \<) making it impossible to place root-form dental implants with a diameter of at least 3 mm and a length of at least 8 mm .as verified by CT.
• Sufficient inter-arch space as verified by probing.
• sufficient restorative space as verified by putty index technique
• Patient seeking for fixed prosthesis

You may not qualify if:

• Patients with absolute contraindications for surgical procedures such as: active cancer ,immunocompromised patients
• Patients with relative contraindications such as: patients with history of para functional habits (bruxism, clenching), bad habits as heavy smoking and alcoholism.. Also patients with history of radiation therapy in the head and neck region
• Patients with contraindication for grafting procedures.
• Non cooperative patients neither who don't attend regular appointments nor following the instructions during construction procedures

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of dentistry , Mansoura University

Al Mansurah, Egypt

Location

MeSH Terms

Interventions

polyetheretherketone

Study Officials

• Salah A. Hegazy, PhD

  salahhegazy2003@yahoo.com

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: January 14, 2022
• Study Start: December 23, 2019
• Primary Completion: December 2, 2021
• Study Completion: December 28, 2021
• Last Updated: January 14, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)