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

Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06071689
• Other study ID #: M0103023RP
• Status: Completed
• Phase: N/A
• Start date: June 23, 2023
• Est. completion date: September 20, 2023

Study information

• Verified date: September 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 20, 2023
• Est. primary completion date: September 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Loss

Intervention

Device:
• screw retained prosthesis
all-on-4 screw-retained prosthesis.

Locations

Country	Name	City	State
Egypt	Khloud Ezzat	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone changes	circumferential peri-implant bone changes in mm	5 years