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

October 8, 2023 updated by: Mansoura University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All patients will receive conventional maxillary and mandibular complete dentures.

2. 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.

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

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

5. 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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, 54790
        • Khloud Ezzat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PEEK group
patients receive all-on-4 prostheses constructed from CAD/CAM milled PEEK framework.
Device: screw retained prosthesis
all-on-4 screw-retained prosthesis.
Other Names:
  • hybrid prosthsis
Active Comparator: Soft metal group
patients receive all-on-4 prostheses constructed from CAD/CAM milled soft metal framework.
Device: screw retained prosthesis
all-on-4 screw-retained prosthesis.
Other Names:
  • hybrid prosthsis
Active Comparator: selective laser melting group
patients receive all-on-4 prostheses constructed from 3D printed selective laser melting Co-Cr framework.
Device: screw retained prosthesis
all-on-4 screw-retained prosthesis.
Other Names:
  • hybrid prosthsis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone changes
Time Frame: 5 years
circumferential peri-implant bone changes in mm
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Khloud Ezzat, PhD, lecturer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2023

Primary Completion (Actual)

September 12, 2023

Study Completion (Actual)

September 20, 2023

Study Registration Dates

First Submitted

October 1, 2023

First Submitted That Met QC Criteria

October 5, 2023

First Posted (Actual)

October 6, 2023

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • M0103023RP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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