Evaluation of PEEK Versus Titanium Bar Attachments With Implant Assisted Mandibular Complete Overdenture Fabricated by CAD/CAM Technology (Evaluation)

November 21, 2025 updated by: Nour Elhouda, Tanta University
Evaluation of PEEK versus Titanium Bar Attachments with Implant Assisted Mandibular Complete Overdenture fabricated by CAD/CAM Technology measuring retention of the overdenture and implant evaluation for 6 months and one year

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

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
    • Elgharbiy
      • Tanta, Elgharbiy, Egypt
        • Faculty of Dentistry

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • • Completely edentulous patients free from systemic diseases that may affect soft or hard tissue healing.

    • Patient's age ranges from 40 to 60 years old.
    • The bone quality and quantity of the mandibular alveolar ridge must fulfill the criteria for implant placement.
    • They have normal class Ӏ maxilla-mandibular relationship and sufficient inter-arch space with at least 25mm for bar attachment.
    • They have good oral hygiene.

Exclusion Criteria:

  • Systemic disorders that may influence soft or hard tissue healing as oral diseases.
  • Patients with history of radiation therapy in the head and neck region.
  • Patients with neurological or psychological problems that may impair good oral hygiene.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Evaluation of PEEK material
digital fabrications techniques
Device: implant overdenture
using of CAD/CAM with new material and digital fabrication techniques
Active Comparator: Group Ӏ (control group): Six patients will receive digital mandibular implant overdenture assisted b
• Clinical evaluation
Device: implant overdenture
using of CAD/CAM with new material and digital fabrication techniques
Experimental: PEEK group new material
Device: implant overdenture
using of CAD/CAM with new material and digital fabrication techniques
Experimental: PEEK material study group
Device: implant overdenture
using of CAD/CAM with new material and digital fabrication techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
retention of mandibular overdenture
Time Frame: 6 months and 12 months post-insertion
Retention of the mandibular implant-assisted complete overdenture will be measured using a digital force meter. Measurements will be taken at 6 months and 12 months after denture insertion.
6 months and 12 months post-insertion

Collaborators and Investigators

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

Sponsor

Tanta University

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)

May 30, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

September 7, 2025

First Submitted That Met QC Criteria

November 21, 2025

First Posted (Estimated)

December 3, 2025

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2140

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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