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

NCT ID: NCT06067334

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-20
• Study Completion Date: 2024-12-10

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.

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.

Conditions

Accuracy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

full arch implant supported screw retained restoration with conventional impression technique

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

full arch implant supported screw retained restoration with conventional digital technique

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Fatma mahanna

lecturer of prosthodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Gamal, MD

Role: PRINCIPAL_INVESTIGATOR

Mansoura university, faculty of dentistry

Locations

Faculty of dentistry, mansoura university

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

J0104023RP

Identifier Type: -

Identifier Source: org_study_id