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NCT06071689 Clinical Trial

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
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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