Accuracy of Tooth Modified Scan Bodies as a Novel Technique

December 11, 2023 updated by: Doaa Adel Salah Khattab, Ain Shams University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Abbassia
      • Cairo, Abbassia, Egypt, 11566
        • ain shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Immediately postoperative
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

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Collaborators

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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