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Clinical Performance of All-on-4 PEEK and Conventional Prostheses

NCT06388395 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-07-25

No results posted yet for this study

Summary

The all-on-4 treatment approach for completely edentulous mandible is a proven concept. However, there are still issues regarding the use of metal substructure to support the prostheses such as allergy, metallic taste, and aesthetic. Therefore, other materials such as polyetheretherketone (PEEK) are being tested for its suitability and is showing good potential. However, available evidence is limited regarding its clinical performance. Thus, the aim of this study is to compare clinical performance of all-on-4 treatment concept utilizing PEEK versus conventional metal framework as substructure in fully edentulous mandible. Thirty suitable patients will receive either PEEK or conventional all-on-4 prostheses for fully edentulous mandible. The prostheses will be retained by four implants utilizing the all-on-4 principle. Clinical performance will be assessed during the follow up period of up 3 years concerning screw loosening, material chipping or fracture, wear or staining, prosthesis survival and success, implant survival and success.

Conditions

  • Failure, Prosthesis
  • Dental Prosthesis, Implant-Supported
  • Survival, Prosthesis
  • Complete Edentulism
  • Complication;Prostheses

Interventions

PROCEDURE

Accuracy of full-arch surgical guides

The accuracy of the surgical guides will be assessed by superimposing the pre and post-treatment CBCT scans.

PROCEDURE

Survival and complications of the prostheses

Two different prostheses will be assessed (conventional and PEEK). All complications will be recorded for a period of 3 years

PROCEDURE

Survival and complications of the implants

The effect of the two different prostheses on implants will be assessed in terms of survival and success rates.

PROCEDURE

Conventional (metal-resin) implant-supported prosthesis

Full-mouth implant-supported conventional prosthesis will be constructed and evaluated for up to 3 years.

PROCEDURE

PEEK implant-supported prosthesis

Full-mouth implant-supported PEEK prosthesis will be constructed and evaluated for up to 3 years.

Sponsors & Collaborators

  • University of Sharjah

    lead OTHER

Principal Investigators

  • Ahmed Aziz, PhD · University of Sharjah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2027-06-30
Completion
2027-08-30

Countries

  • United Arab Emirates

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06388395 on ClinicalTrials.gov