Accuracy of Tooth Modified Scan Bodies as a Novel Technique

Accuracy of Tooth Modified Scan Bodies as a Novel Technique for Edentulous Full Arch Implant Supported Dental Prosthesis: A Controlled Clinical Trial

The clinical performance of a novel scan body Tooth Modified Scan Body (TMSB) in the degree of trueness of IOS impression for full arch cases.

I

Study Overview

• Status: Completed
• Conditions: Digital Technology; Dental
• Intervention / Treatment: Device: Tooth modified scan bodies; Device: Conventional scan bodies

Detailed Description

The clinical performance of a novel scan body Tooth Modified Scan Body (TMSB) in the degree of trueness of IOS impression for full arch cases. TMSB is a scan body to which different teeth are attached directly as one piece, this may enhance the accuracy level by filling the gabs between ISB as well as acting as a stable artificial AI-easily recognized landmarks thus facilitating the scanning procedure. OS impression utilizing tooth modified scan bodies or conventional scan bodies result in the same degree of trueness as conventional verified splinted open tray impression. To our knowledge, it is the first time in the literature to utilize a novel scan body modified with directly connected teeth as artificial landmarks in vivo.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Abbassia
    • Cairo, Abbassia, Egypt, 11566
      • Ain shams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants who had received 4-6 implants in 1 edentulous arch.
• Participants with 1-piece implant-supported complete-arch fixed dental prostheses.
• Systemically free.
• Primary implant stability exceed 72 the day of the definitive impression.

Exclusion Criteria:

• Smoker's.
• Non co-operative patients.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tooth Modified Scan Bodies; The intraoral scanner (IOS) impression will be recorded using modified scan bodies. The IOS device will be calibrated right before the impression. The scan strategy will be consistent for all the procedures following the manufacturer guidelines.	Device: Tooth modified scan bodies; Tooth modified scan bodies are used during scanning for full arch implant cases.
Placebo Comparator: Conventional Scan Bodies; The intraoral scanner (IOS) impression will be recorded using conventional implant scan bodies secured at the multiunit abutment level.	Device: Conventional scan bodies; Conventional scan bodies will be used for scanning the full arch implant cases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of trueness	Digital files will be obtained: either conventional scan or TMSB scan. All the STL files will be imported to dental CAD software , and scan bodies will be converted to implant multi-unit ti-base replicas using a digital library. Then, updated STL files will be imported to inspection software for trueness assessments.	Immediately postoperative

Collaborators and Investigators

• Sponsor: Ain Shams University
• Collaborators: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Actual): October 18, 2023
• Study Completion (Actual): November 20, 2023

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Estimated): December 20, 2023

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Jaw relation; Scan body
• Other Study ID Numbers: 22859

Drug and device information, study documents

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