Complete Digital Workflow

Complete Digital Workflow for Construction of Full Arch Implant Supported Screw Retained Restoration: Clinical Evaluation of Titanium-zirconium Versus Peek-composite

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Digital Intervention
• Intervention / Treatment: Device: Implant supported prosthesis

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt
    • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:i- Systemic disease: uncontrolled diabetes mellitus, cardiovascular disease, immunodeficiency disorders, blood disorders such as coagulation disorders, severe osteoporosis, and any metabolic disease that might influence the rate of bone resorption ii- Long-term medication use: steroid, anti-epileptic drugs, drugs favoring gingival overgrowth, bispho- sphonates (bisphosphonate injections or more than 4 years of oral bisphosphonate use), and any medi- cation that influences the rate of bone loss or sur- vival of dental implants. iii- Infection of human immunodeficiency virus, hepatitis B virus, or syphilis iv- Bruxism v- Maxillofacial tumor

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group1; • the titanium group involved patients who will be received ISFCDs with individual zirconium veneers	Device: Implant supported prosthesis; implant supported full arch prosthesis
Active Comparator: group 2; 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; implant supported full arch prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prosthetic complication	Complication will be evaluated clinically	one year
Marginal Bone loss	Bone loss will be evaluated Radiographically around dental implants	one year

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2023
• Primary Completion (Actual): July 20, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: July 21, 2025
• First Submitted That Met QC Criteria: July 28, 2025
• First Posted (Actual): July 29, 2025

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: J0204023RP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No