PEEK Vs Titanium for All-on-4 Prosthesis

NCT06700733 | Completed

• 1 other identifier: A0508024RP
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Satisfaction, Patient; Bite Force

Keywords

PEEK; Titanium; All-on-4

Outcome Measures

Primary Outcomes (2)

• patient satisfaction

  Patient satisfaction will be evaluated using a questionnaire based on a visual analog scale

  3 month

• chewing efficiency

  Chewing efficiency will be evaluated using the color mixing ability test

  3 month

Secondary Outcomes (2)

• Oral health-related quality of life (OHRQoL)

  3 month

• maximum bite force (BF)

  3 month

Study Arms (2)

study group

EXPERIMENTAL

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; Device: Titanium prosthesis

study group 1

EXPERIMENTAL

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; Device: Titanium prosthesis

Interventions

PEEK prosthesis DEVICE

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.

Also known as: Titanium prosthesis

study group; study group 1

Titanium prosthesis DEVICE

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.

study group; study group 1

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Khloud Ezzat

Al Mansurah, 54790, Egypt

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Khloud Ezzat, PhD

  Lecturer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: All selected patients will receive maxillary complete dentures and mandibular screw-retained prosthesis either from PEEK or Titanium framework in a crossover design.

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 22, 2024
• Study Start: February 23, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 12, 2023
• Last Updated: January 7, 2025

Record last verified: 2024-11

Locations

EG (1)