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Radiographic Evaluation of All-on-4 Implant Prosthesis With Different Materials and Bar Construction Techniques

M

Mansoura University

Status

Completed

Conditions

Bone Loss

Treatments

Device: screw retained prosthesis

Study type

Interventional

Funder types

Other

Identifiers

NCT06071689
M0103023RP

Details and patient eligibility

About

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.

Full description

All patients will receive conventional maxillary and mandibular complete dentures.

  1. 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.

  2. Abutment level impression will be made, and the resultant cast will be 3D scanned for CAD/CAM construction of superstructure with abutments.

  3. patients will be randomly divided into three groups according to the framework materials: PEEK, Soft metal, and selective laser melting construction.

  4. 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.

Evaluation Radiographic evaluation of circumferential bone level around implants and bone changes in the posterior mandible will be done using CBCT at one, two, three, and five years after insertion of the final prosthesis.

Enrollment

18 patients

Sex

All

Ages

40 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

18 participants in 3 patient groups

PEEK group
Active Comparator group
Description:
patients receive all-on-4 prostheses constructed from CAD/CAM milled PEEK framework.
Treatment:
Device: screw retained prosthesis
Soft metal group
Active Comparator group
Description:
patients receive all-on-4 prostheses constructed from CAD/CAM milled soft metal framework.
Treatment:
Device: screw retained prosthesis
selective laser melting group
Active Comparator group
Description:
patients receive all-on-4 prostheses constructed from 3D printed selective laser melting Co-Cr framework.
Treatment:
Device: screw retained prosthesis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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