Wear Assessment of Novel PEEK Telescopic Attachment for Overdenture

May 23, 2024 updated by: Hamada Zaki Mahross Atia

Wear Assessment of Novel PEEK Telescopic Attachment for Implant Retained Mandibular Overdenture

To assess the wear of Zirconia-PEEK versus cobalt-chromium-PEEK telescopic attachments for implant retained complete mandibular overdenture. The wear of Zirconia-PEEK telescopic attachments can affect the retention of implant retained complete mandibular overdenture.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Twelve completely edentulous patients were randomly chosen for implant retained telescopic overdentures construction and divided into two groups, where group I was a patient with zirconia copy, and group II was with cobalt chromium CoCr copy. The PEEK was constructed for both groups as a secondary coping telescopic attachment for the denture. The wear measurements of PEEK were performed optically by using a USB digital microscope with a built-in camera connected to a compatible personal computer at different intervals of baseline, 3, 6, and 9 months. The data was statistically analyzed and compared using student t-test, ANOVA, and Post Hoc Test.

Study Type

Interventional

Enrollment (Actual)

20

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
      • Cairo, Egypt, 11884
        • Hamada Zaki Mahross

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:

  • completely edentulous
  • free from any dental or systemic diseases

Exclusion Criteria:

  • medically ill fit patient
  • female patient

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patient with zirconia copy
Group I (study group) was the group of patients with zirconia as a primary copings that attach to the abutment and PEEK as a secondary coping telescopic attachment that attaches to the fitting surface of the denture.
Procedure: implant overdenture
Following the two-stage surgical protocol, two dental implant fixtures with a length of 10 mm and a diameter of 3.7 mm were inserted at the canine area of the mandibular alveolar ridge.
Experimental: patients with cobalt chromium (CoCr) as primary copings
Group II (control group) was the group of patients with cobalt chromium (CoCr) as primary copings attached to the abutment and PEEK as a secondary coping's telescopic attachment attached to the fitting surface of the denture.
Procedure: implant overdenture
Following the two-stage surgical protocol, two dental implant fixtures with a length of 10 mm and a diameter of 3.7 mm were inserted at the canine area of the mandibular alveolar ridge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the mean wear values
Time Frame: at baseline
measurement of the mean of wear between two test groups
at baseline
the mean wear values
Time Frame: after 3 months interval
measurement of the mean of wear between two test groups
after 3 months interval
the mean wear values
Time Frame: after 6 months interval
measurement of the mean of wear between two test groups
after 6 months interval

Collaborators and Investigators

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

Sponsor

Hamada Zaki Mahross Atia

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 11, 2024

Primary Completion (Actual)

April 20, 2024

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

May 19, 2024

First Submitted That Met QC Criteria

May 23, 2024

First Posted (Actual)

May 30, 2024

Study Record Updates

Last Update Posted (Actual)

May 30, 2024

Last Update Submitted That Met QC Criteria

May 23, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 751/306

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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