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

NCT06067334 | Completed

• 1 other identifier: J0104023RP
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Accuracy

Keywords

Accuracy; implant level impression; abutment level impression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Passive fit

  3 months

Study Arms (2)

Conventional (Open tray impression technique)

ACTIVE COMPARATOR

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

Digital impression

ACTIVE COMPARATOR

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

Interventions

full arch implant supported screw retained restoration with conventional impression technique OTHER

surgical procedures: Implant installation Prosthetic procedures: Conventional impression fabrication of full arch implant supported screw-retained restoration evaluation: Accuracy, Passive fit

Conventional (Open tray impression technique)

full arch implant supported screw retained restoration with conventional digital technique OTHER

surgical procedures: Implant installation Prosthetic procedures: Digital impression fabrication of full arch implant-supported screw-retained restoration evaluation: Accuracy, Passive fit

Digital impression

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of dentistry, mansoura university

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Study Officials

• Ahmed Gamal, MD

  Mansoura university, faculty of dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of prosthodontics

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 4, 2023
• Study Start: July 20, 2023
• Primary Completion: November 20, 2024
• Study Completion: December 10, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)