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

NCT ID: NCT06071689

Last Updated: 2023-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-23

Study Completion Date

2023-09-20

Brief Summary

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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

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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.

Conditions

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Bone Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PEEK group

patients receive all-on-4 prostheses constructed from CAD/CAM milled PEEK framework.

Group Type ACTIVE_COMPARATOR

screw retained prosthesis

Intervention Type DEVICE

all-on-4 screw-retained prosthesis.

Soft metal group

patients receive all-on-4 prostheses constructed from CAD/CAM milled soft metal framework.

Group Type ACTIVE_COMPARATOR

screw retained prosthesis

Intervention Type DEVICE

all-on-4 screw-retained prosthesis.

selective laser melting group

patients receive all-on-4 prostheses constructed from 3D printed selective laser melting Co-Cr framework.

Group Type ACTIVE_COMPARATOR

screw retained prosthesis

Intervention Type DEVICE

all-on-4 screw-retained prosthesis.

Interventions

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screw retained prosthesis

all-on-4 screw-retained prosthesis.

Intervention Type DEVICE

Other Intervention Names

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hybrid prosthsis

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Khloud Ezzat, PhD

Role: PRINCIPAL_INVESTIGATOR

Lecturer

Locations

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Khloud Ezzat

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

References

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Mourad KE, Rashed NHAH, Altonbary GY, Fattah Hegazy SA. Five years of radiographic evaluation for the peri-implant bone changes of all-on-four implant prostheses constructed from different framework materials using different digital construction techniques. BMC Oral Health. 2024 Aug 7;24(1):910. doi: 10.1186/s12903-024-04642-7.

Reference Type DERIVED
PMID: 39112988 (View on PubMed)

Other Identifiers

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M0103023RP

Identifier Type: -

Identifier Source: org_study_id

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