Prosthetic Maintenance of Two Implant-Retained Overdentures Reinforced With PEKK Versus Co-Cr Frameworks

January 20, 2024 updated by: Omnia M Refai, Ain Shams University

Prosthetic Maintenance Assessment for Two Implant-Retained Overdentures Reinforced With PEKK Versus Co-Cr Framework: A Randomized Controlled Clinical Trial

The goal of this randomized clinical trial is to compare and assess the prosthetic maintenance of two implant-retained mandibular overdentures reinforced with PEKK and Co-Cr frameworks after twelve months. Twenty-four participants were randomly assigned to two groups: Group I received a mandibular implant-retained overdenture reinforced with a Co-Cr framework, while Group II received a mandibular implant-retained overdenture reinforced with a PEKK framework. Also, both groups were rehabilitated with a maxillary complete removable denture.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Twenty-four participants with edentulous maxillary and mandibular ridges underwent meticulous selection, with two implants placed in the mandibular canine areas through a two-stage surgical technique facilitated by a radiographic and surgical stent. Following this, patients were provided with maxillary and mandibular complete removable dentures relined with soft liners. After the subsequent three-month osseointegration period, ball attachments were introduced. Patients were randomly allocated to two groups based on the type of prosthesis they received. Group I received mandibular implant-retained overdenture reinforced with the Co-Cr framework, while Group II received mandibular implant-retained overdenture reinforced with the PEKK framework, both groups received complete removable dentures for the maxillary arch. The assessment of prosthetic maintenance for mandibular implant-retained overdentures in both groups was conducted twelve months post-denture insertion.

Study Type

Interventional

Enrollment (Actual)

24

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
    • Nasr City
      • Cairo, Nasr City, Egypt, 11566
        • Faculty of dentistry, ain shams university

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:

  • Age range between 50-70 years old.
  • Completely edentulous patients
  • Systemically free from any disease that contraindicates implant placement.
  • A minimum of 12 -15 millimeters of bone height and 6 mm bone width at canine areas diagnosed from the pre-operative cone beam CT.
  • Sufficient inter-arch space (15mm) to accommodate the mandibular implant-retained overdentures.

Exclusion Criteria:

  • Patients with bone or mucosal diseases.
  • Heavy smokers.
  • Patients with uncontrolled metabolic disorders such as diabetes mellitus.
  • Patients with parafunctional habits.
  • Patients with conditions that might complicate the treatment, such as: severe gag reflex, limited mouth opening.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mandibular implant-retained overdenture reinforced with a Co-Cr framework
The patient received a mandibular implant-retained acrylic overdenture reinforced with a Co-Cr framework. The framework is manufactured by milling polymethylmethacrylate (PMMA) and then the PMMA undergo conventional casting to produce cobalt chromium (Co-Cr) framework. The framework included in the overdenture by conventional processing technique.
Device: Two implant -retained overdenture reinforced with Co-Cr framework
The intervention is made from polymethylmethacrylate reinforced with cobalt chromium ( Co-Cr) framework.
Other Names:
  • implant retained overdenture
Active Comparator: Mandibular implant-retained overdenture reinforced with a PEKK framework
The patient received a mandibular implant-retained acrylic overdenture reinforced with a Polyetherketoneketone (PEKK) framework. The framework is manufactured by milling PEKK the framework included in the overdenture by conventional processing technique.
Device: Two implant -retained overdenture reinforced with PEEK framework
The intervention is made from polymethylmethacrylate reinforced with Polyetherketoneketone ( PEEK) framework.
Other Names:
  • implant retained overdenture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Prosthetic Maintenance of both types of implant retained overdentures
Time Frame: twelve months after delivery of implant retained overdenture
Evaluation of prosthetic maintenance for mandibular implant-retained overdentures in both groups was made after twelve months of overdenture insertion. Prosthetic maintenance is a checklist for the following aspects that were inspected regarding screw (screw loosening, screw fracture), attachments (wear, distortion, fracture, replacement), and overdentures (reline, remake, fracture, teeth wear, teeth separation, or fracture).maintenance for complication assed through counting frequency of incidence. The unit of measurement used is percentage.
twelve months after delivery of implant retained overdenture

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Omnia MS Refai, PHD, Faculty of Dentistry ,Ain Shams University
  • Principal Investigator: Heba A Salama, PHD, Faculty of Dentistry , Misr International Univeristy

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)

August 1, 2022

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

January 11, 2024

First Submitted That Met QC Criteria

January 20, 2024

First Posted (Actual)

January 23, 2024

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 20, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDASU-Rec PC 122352

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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