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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06219811
Enrollment
24
Registered
2024-01-23
Start date
2022-08-01
Completion date
2024-01-01
Last updated
2024-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Completely Edentulous

Keywords

Dental implants, Maintenance/standards, Overdenture

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.

Interventions

DEVICETwo implant -retained overdenture reinforced with Co-Cr framework

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

DEVICETwo implant -retained overdenture reinforced with PEEK framework

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
50 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of Prosthetic Maintenance of both types of implant retained overdenturestwelve months after delivery of implant retained overdentureEvaluation 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026