Complete Digital Workflow for Construction of Full Arch Implant Supported Screw Retained Restoration

Complete Digital Workflow for Construction of Full Arch Implant Supported Screw Retained Restoration: Accuracy of Different Impressions Techniques on Implant and Abutment Levels (Cross-over Study)

aim: to compare the accuracy of the conventional and digital impression when will be performed on implant level or abutment level in Complete digital workflow for construction of full arch implant supported screw-retained restoration.

Study Overview

• Status: Completed
• Conditions: Accuracy
• Intervention / Treatment: Other: full arch implant supported screw retained restoration with conventional impression technique; Other: full arch implant supported screw retained restoration with conventional digital technique

Detailed Description

The patient will be selected according to the following criteria:

1. Free from any systemic disease that may interfere with proper Osseointegration of implants, which will be assessed by thorough medical investigations.
2. Patients having completely edentulous maxilla and mandible for at least 6 months after the last extraction.
3. Normal maxilla mandibular relationship with adequate inter-arch space, measured by tentative jaw relation.
4. Sufficient residual alveolar ridge.

Exclusion criteria include:

1. Local or general contraindications for surgical procedures.
2. Patients with TMJ disorders or poor neuromuscular coordination or parafunctional habits.
3. Severe inter-maxillary skeletal discrepancy or limited inter-arch space.

4. Heavy smokers.

   • For all patients, conventional complete dentures are constructed.
   • Implants installed in the edentulous maxilla and mandible in each target position guided by stereolithographic stent. A delayed loading protocol is followed in this study.
   • After osseointegration, a conventional open tray splinted impression technique will be made for each patient on the implant/abutment level.
   • Scan bodies' implant level/abutment level will be tightened for each patient, and a digital intraoral scanner will be used to scan the scan bodies for making implant level/abutment level digital impressions.

Accuracy will be evaluated as follows:

• 3D inspection software using the best-fit alignment algorithm will be utilized to calculate the 3D deviation of each impression using the root mean square (RMS) error.
• Passive fit of the framework will be evaluated at the time of insertion.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35511
      • Faculty of Dentistry, Mansoura University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Free from any systemic disease that may interfere with proper Osseointegration of implants, which will be assessed by thorough medical investigations.
• Patients having completely edentulous maxilla and mandible for at least 6 months after the last extraction.
• Normal maxilla mandibular relationship with adequate inter-arch space as verified by tentative jaw relation.
• Sufficient residual alveolar ridge.

Exclusion Criteria:

• Local or general contraindications for surgical procedures.
• Patients with TMJ disorders or poor neuromuscular coordination or parafunctional habits.
• Severe inter-maxillary skeletal discrepancy or limited inter-arch space.
• Heavy smokers.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional (Open tray impression technique); After osseointegration, a conventional open tray splinted impression technique will be made for each patient on the implant/abutment level.	Other: full arch implant supported screw retained restoration with conventional impression technique; surgical procedures: Implant installation Prosthetic procedures: Conventional impression fabrication of full arch implant supported screw-retained restoration evaluation: Accuracy, Passive fit
Active Comparator: Digital impression; Scan bodies implant level/abutment level will be tightened for each patient, and a digital intraoral scanner will be used to scan the scan bodies for making implant level/abutment level digital impressions.	Other: full arch implant supported screw retained restoration with conventional digital technique; surgical procedures: Implant installation Prosthetic procedures: Digital impression fabrication of full arch implant-supported screw-retained restoration evaluation: Accuracy, Passive fit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best fit alignment to calculate 3D deviation of each impression	3D inspection software (Geomagic Control X) using the best-fit alignment algorithm will be utilized to calculate the 3D deviation of each impression using the root mean square (RMS) error.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Passive fit	Passive fit of framework will be evaluated at time of insertion (Sheffield test)	3 months

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Ahmed Gamal, MD, Mansoura University, Faculty of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2023
• Primary Completion (Actual): November 20, 2024
• Study Completion (Actual): December 10, 2024

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 4, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 4, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Accuracy; implant level impression; abutment level impression
• Other Study ID Numbers: J0104023RP

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