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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2024-01-01

Brief Summary

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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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Detailed Description

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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

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Completely Edentulous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Two implant -retained overdenture reinforced with Co-Cr framework

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Two implant -retained overdenture reinforced with PEEK framework

Intervention Type DEVICE

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

Interventions

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Two implant -retained overdenture reinforced with Co-Cr framework

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

Intervention Type DEVICE

Two implant -retained overdenture reinforced with PEEK framework

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

Intervention Type DEVICE

Other Intervention Names

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implant retained overdenture implant retained overdenture

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes