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

Ain Shams University

Status: Completed

Conditions: Completely Edentulous

Treatments: Device: Two implant -retained overdenture reinforced with PEEK framework; Device: Two implant -retained overdenture reinforced with Co-Cr framework

Study type: Interventional

Funder types: Other

Identifiers

NCT06219811

FDASU-Rec PC 122352

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: Male

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Mandibular implant-retained overdenture reinforced with a Co-Cr framework

Experimental group

Description:

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.

Treatment:

Device: Two implant -retained overdenture reinforced with Co-Cr framework

Mandibular implant-retained overdenture reinforced with a PEKK framework

Active Comparator group

Description:

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.

Treatment:

Device: Two implant -retained overdenture reinforced with PEEK framework