NCT06071689

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 23, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2023

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2023

Completed
Last Updated

October 11, 2023

Status Verified

September 1, 2023

Enrollment Period

3 months

First QC Date

October 1, 2023

Last Update Submit

October 8, 2023

Conditions

Bone Loss

Keywords

All-on-Four implantPEEK frameworkSoft metalSelective laser melting

Outcome Measures

Primary Outcomes (1)

  • bone changes

    circumferential peri-implant bone changes in mm

    5 years

Study Arms (3)

PEEK group

ACTIVE COMPARATOR

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

Device: screw retained prosthesis

Soft metal group

ACTIVE COMPARATOR

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

Device: screw retained prosthesis

selective laser melting group

ACTIVE COMPARATOR

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

Device: screw retained prosthesis

Interventions

screw retained prosthesisDEVICE

all-on-4 screw-retained prosthesis.

Also known as: hybrid prosthsis
PEEK groupSoft metal groupselective laser melting group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • History of para-functional habits (Bruxism, clenching), smoking, and alcoholism.
  • History of radiation therapy in the head and neck region.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khloud Ezzat

Al Mansurah, 54790, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 39112988DERIVED

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Khloud Ezzat, PhD

    Lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2023

First Posted

October 6, 2023

Study Start

June 23, 2023

Primary Completion

September 12, 2023

Study Completion

September 20, 2023

Last Updated

October 11, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)