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Completed

NCT Number: NCT06219811

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

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.

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Key information

Age range

50 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Ain shams University

Cairo, Nasr City, 11566, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Two implant -retained overdenture reinforced with Co-Cr framework

Device

The intervention is made from polymethylmethacrylate reinforced with cobalt chromium ( Co-Cr) framework.

Other names: implant retained overdenture

Two implant -retained overdenture reinforced with PEEK framework

Device

The intervention is made from polymethylmethacrylate reinforced with Polyetherketoneketone ( PEEK) framework.

Other names: implant retained overdenture

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jan 23, 2024
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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