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

NCT06219811 | Completed

• 1 other identifier: FDASU-Rec PC 122352
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Completely Edentulous

Keywords

Dental implants; Maintenance/standards; Overdenture

Outcome Measures

Primary Outcomes (1)

• Evaluation of Prosthetic Maintenance of both types of implant retained overdentures

  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.

  twelve months after delivery of implant retained overdenture

Study Arms (2)

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

EXPERIMENTAL

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.

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

Mandibular implant-retained overdenture reinforced with a PEKK framework

ACTIVE COMPARATOR

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.

Device: Two implant -retained overdenture reinforced with PEEK framework

Interventions

Two implant -retained overdenture reinforced with Co-Cr framework DEVICE

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

Also known as: implant retained overdenture

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

Two implant -retained overdenture reinforced with PEEK framework DEVICE

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

Also known as: implant retained overdenture

Mandibular implant-retained overdenture reinforced with a PEKK framework

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry, Ain shams University

Cairo, Nasr City, 11566, Egypt

Location

Study Officials

• Omnia MS Refai, PHD

  Faculty of Dentistry ,Ain Shams University

  PRINCIPAL INVESTIGATOR

• Heba A Salama, PHD

  Faculty of Dentistry , Misr International Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Oral and Maxillofacial Prosthodontics

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 23, 2024
• Study Start: August 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)