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

Not Applicable

Completed

• Conditions: Completely Edentulous
• Interventions: Device: Two implant -retained overdenture reinforced with PEEK framework; Device: Two implant -retained overdenture reinforced with Co-Cr framework

• Registration Number: NCT06219811
• Lead Sponsor: Ain Shams University

Brief 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.

Study Timeline

• Study Start: 2022-08-01
• Primary Completion: 2023-12-01
• Status Verified: 2024-01
• Study Completion: 2024-01-01
• Study First Submitted: 2024-01-11
• Study First Submitted QC: 2024-01-20
• Last Update Submitted: 2024-01-20
• Study First Posted: 2024-01-23
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mandibular implant-retained overdenture reinforced with a PEKK framework	Two implant -retained overdenture reinforced with PEEK 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.
Mandibular implant-retained overdenture reinforced with a Co-Cr framework	Two implant -retained overdenture reinforced with 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.

Primary Outcome Measures

Name	Time	Method
Evaluation of Prosthetic Maintenance of both types of implant retained overdentures	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Ain shams University; 🇪🇬 Cairo, Nasr City, Egypt