NCT07091786

Brief Summary

This study will aim to clinical evaluation of titanium-zirconium and peek-composite of screw retained prosthesis used for rehabilitation of edentulous patients using Complete digital workflow for construction of full arch implant supported screw retained restoration.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

October 30, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 21, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 29, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

9 months

First QC Date

July 21, 2025

Last Update Submit

July 28, 2025

Conditions

Digital Intervention

Outcome Measures

Primary Outcomes (2)

  • Prosthetic complication

    Complication will be evaluated clinically

    one year

  • Marginal Bone loss

    Bone loss will be evaluated Radiographically around dental implants

    one year

Study Arms (2)

group1

ACTIVE COMPARATOR

• the titanium group involved patients who will be received ISFCDs with individual zirconium veneers

Device: Implant supported prosthesis

group 2

ACTIVE COMPARATOR

The PEEK group included patients who will be received ISFCDs with individual PMMA composite veneers cemented onto a CAD-CAM PEEK framework

Device: Implant supported prosthesis

Interventions

Implant supported prosthesisDEVICE

implant supported full arch prosthesis

group 2group1

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • i- Edentulous jaws ii- Good oral hygiene and good compliance. iii- Angel's class I maxillo-mandibular relationship and a minimum of 16mm mandibular restorative space at the estimated occlusal vertical dimension. This will be verified by recoding a tentative jaw relation iv- Adequate bone height and width for placement of standard diameter implants. A cone beam computerized tomographic scan will be taken prior to surgery to determine the bone quality and bone volume

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Egypt

Location

MeSH Terms

Interventions

Dental Prosthesis, Implant-Supported

Intervention Hierarchy (Ancestors)

Dental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and Supplies

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2025

First Posted

July 29, 2025

Study Start

October 30, 2023

Primary Completion

July 20, 2024

Study Completion

October 1, 2025

Last Updated

July 29, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)