Radiographic Evaluation of the Peri-implant Circumferential Bone Level and Bone Changes in the Posterior Mandible of All-on-4 Implant Prosthesis With Different Materials and Bar Construction Techniques
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- bone changes
Study Overview
Brief Summary
Eighteen patients will be selected from the outpatient clinic of the Prosthodontic Department, Faculty of Dentistry, Mansoura University seeking prosthetic rehabilitation.
patients will be randomly divided into three groups according to the framework materials: PEEK, Soft metal, and selective laser melting construction.
Detailed Description
All patients will receive conventional maxillary and mandibular complete dentures.
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The mandibular denture will be modified by shortening the flanges and cutting the posterior part till the 1st molar then 3D scanned for recording the correct dimension of each tooth to be concerned during the construction of the superstructure and the final prosthesis.
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Abutment level impression will be made, and the resultant cast will be 3D scanned for CAD/CAM construction of superstructure with abutments.
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patients will be randomly divided into three groups according to the framework materials: PEEK, Soft metal, and selective laser melting construction.
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The fit of the framework will be verified intraorally, and the final prosthesis will be digitally constructed; according to the dimensions of the scanned denture; to fit over the framework.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Completely edentulous maxillary ridges and mandibular arch with four implants placed according to the All-on-4 distribution. All patients were recruited from the previous study.
- •All selected patients will be with sufficient inter-arch space and restorative space.
- •All selected patients will have healthy ridges covered by the compressible oral mucosa and free from any ridge flabbiness.
Exclusion Criteria
- •History of para-functional habits (Bruxism, clenching), smoking, and alcoholism.
- •History of radiation therapy in the head and neck region.
Arms & Interventions
PEEK group
patients receive all-on-4 prostheses constructed from CAD/CAM milled PEEK framework.
Intervention: screw retained prosthesis (Device)
Soft metal group
patients receive all-on-4 prostheses constructed from CAD/CAM milled soft metal framework.
Intervention: screw retained prosthesis (Device)
selective laser melting group
patients receive all-on-4 prostheses constructed from 3D printed selective laser melting Co-Cr framework.
Intervention: screw retained prosthesis (Device)
Outcomes
Primary Outcomes
bone changes
Time Frame: 5 years
circumferential peri-implant bone changes in mm
Secondary Outcomes
No secondary outcomes reported