PEEK Vs Titanium for All-on-4 Prosthesis

January 5, 2025 updated by: Khloud Ezzat, Mansoura University

Polyetheretherketone (PEEK) Versus Titanium Frameworks for All-on-4 Implant Full-arch Prosthesis: Within-patient Evaluation of Patient Satisfaction, Oral Health-related Quality of Life (OHRQoL), Chewing Efficiency and Maximum Bite Force

This crossover clinical study will examine the impact of the framework material of implant-supported prostheses on patient satisfaction and Oral Health-Related Quality of Life (OHRQoL) with mandibular All-on-4 implant distribution. The trial will investigate subject satisfaction, OHRQoL as the primary outcome, and chewing efficiency and maximum bite force as secondary outcomes for different framework materials used in implant-supported screw-retained restorations. The first null hypothesis states no significant difference in patient satisfaction and OHRQoL between the tested prostheses. Additionally, the second null hypothesis states no significant difference in chewing efficiency and maximum bite force between the tested prostheses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prosthetic steps

  1. For each patient, an abutment-level impression will be made, and the resultant cast will be 3D scanned for CAD/CAM construction of a PEEK superstructure with abutments.
  2. A verification jig will be constructed to ensure the accuracy of the cast.
  3. The final prosthesis will be virtually planned by using the Exo-Cad software.
  4. The final prosthesis will be milled in Duralay polymerized resin disk, and the prosthesis resin pattern will be tried intra-orally for passive fit using a screw test.
  5. For the PP, The PEEK framework will be constructed, the fit of the PEEK framework will be verified intraorally, and the final screw-retained prosthesis will be constructed of PMMA teeth and a visiolign pink composite estimating the gingival tissue.
  6. For the TP, the framework will be milled from Ti blocks according to the virtual design of the final prosthesis framework. PMMA teeth then will be cemented, and the final prosthesis will be screwed.

Evaluation

  1. Patient satisfaction (VAS) Patient satisfaction will be evaluated using a questionnaire based on a visual analog scale (VAS).(21) Patients will be asked to mark their answer (amount of satisfaction) on a 100-mm line (with zero referring to not satisfied at all and 100 referring to completely satisfied). The mean of the answers (length of the lines from zero to the marks in mm) for each question was subjected to statistical analysis.
  2. Oral health-related quality of life (OHIP-14) The oral health impact profile (OHIP-14) questionnaire was used to measure OHRQoL. The full OHIP questionnaire consisted of 49 items covering seven main domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, and social disability. The OHIP-14 questionnaires were translated into Arabic by linguistic professionals who worked in collaboration with the authors to prepare the final version.
  3. Evaluation of masticatory efficiency: Chewing efficiency will be evaluated using the color mixing ability test.
  4. Evaluation of maximum bite force (BF): A digital BF transducer will be used to evaluate maximum BF in Newton (N).

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, 54790
        • Khloud Ezzat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

The inclusion criteria include

  • healthy male patients free from systemic diseases that may affect bone health, such as uncontrolled diabetes mellitus and osteoporosis.
  • implants placed with the All-on-4 concept in the mandible.

Exclusion Criteria:

  • The exclusion criteria: the patients with a history of parafunctional habits (bruxism and clenching), smoking, and alcoholism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group
The first 9 patients will receive the PEEK prosthesis (PP) first. After 3 months, chewing efficiency, maximum bite force, patient satisfaction, and OHRQoL will be measured, and PP will be replaced by a Titanium prosthesis (TP). After another 3 months, the measurements will be repeated.
Device: PEEK prosthesis
For the PP, The PEEK framework will be constructed, the fit of the PEEK framework will be verified intraorally, and the final screw-retained prosthesis will be constructed of PMMA teeth and a visiolign pink composite estimating the gingival tissue.
Other Names:
  • Titanium prosthesis
Device: Titanium prosthesis
For the TP, the framework will be milled from Ti blocks according to the virtual design of the final prosthesis framework. PMMA teeth then will be cemented, and the final prosthesis will be screwed.
Experimental: study group 1
The second 9 patients will receive TP first, and after 3 months, measurements will be made. Then, TP was replaced by PP, and measurements will be repeated after another 3 months. This randomization will be made to reduce the effect of prosthesis type and bias
Device: PEEK prosthesis
For the PP, The PEEK framework will be constructed, the fit of the PEEK framework will be verified intraorally, and the final screw-retained prosthesis will be constructed of PMMA teeth and a visiolign pink composite estimating the gingival tissue.
Other Names:
  • Titanium prosthesis
Device: Titanium prosthesis
For the TP, the framework will be milled from Ti blocks according to the virtual design of the final prosthesis framework. PMMA teeth then will be cemented, and the final prosthesis will be screwed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient satisfaction
Time Frame: 3 month
Patient satisfaction will be evaluated using a questionnaire based on a visual analog scale
3 month
chewing efficiency
Time Frame: 3 month
Chewing efficiency will be evaluated using the color mixing ability test
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral health-related quality of life (OHRQoL)
Time Frame: 3 month
The oral health impact profile (OHIP-14) questionnaire was used to measure OHRQoL.
3 month
maximum bite force (BF)
Time Frame: 3 month
A digital BF transducer will be used to evaluate maximum BF in Newton (N)
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Khloud Ezzat, PhD, lecturer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2022

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

March 12, 2023

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

November 20, 2024

First Posted (Actual)

November 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 5, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A0508024RP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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