NCT06219811

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Male
• Age: 50 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Completely Edentulous

Interventions

Type	Name	Description
DEVICE	Two implant -retained overdenture reinforced with Co-Cr framework	The intervention is made from polymethylmethacrylate reinforced with cobalt chromium ( Co-Cr) framework.
DEVICE	Two implant -retained overdenture reinforced with PEEK framework	The intervention is made from polymethylmethacrylate reinforced with Polyetherketoneketone ( PEEK) framework.

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-12-01
• Completion: 2024-01-01
• First posted: 2024-01-23
• Last updated: 2024-01-23

Locations

1 site across 1 country: Egypt