Comparing Scanning Accuracy of Full-Arch Maxillary Implants: Extraoral vs. Intraoral Techniques

NCT06669065 | Active Not Recruiting

• 1 other identifier: 2024/0016
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Data acquisition from the patients: After 4 months of implant placement, three impressions/scans will be made for each patient as follows: Data 1: conventional impression using open tray transfer copings and silicon impression material. After cast verification, the scan bodies will be connected to the analogues on the master cast, which will be scanned using a laboratory scanner. The STL file will be used as a reference scan. Data 2: The scan bodies will be connected to the implants intraorally, and an intraoral scan will be made using the intraoral scanner. The STL file will be stored for comparison. Data 3: the scan bodies will be splinted using dental floss after being connected to the implants intraorally and then a scan will be made using the intraoral scanner. The STL file will be stored for comparison. \- Data alignment and accuracy measurements: The accuracy measurement will be done based on ISO 5725 in which a combination of trueness and precision was approved to define the accuracy of the measurement method. (15) The scanned data will be compared as follows: the STL files from the intraoral digital scans (data 2 and 3) and the extraoral scan of the master cast (data 1) will be imported into a 3D inspection software program that is a metrology program used to analyse and compare 3D meshes. The information for both reference and targets (the scanned data to be compared) will be uploaded into the program and the area of interest of 3D meshes will be marked, The "3D Compare" function will be employed by projecting all paired points with a colour-coded map created to display the deviation patterns of the investigated surfaces. The superimpositions will be used to assess the 3D accuracy for both the digital intraoral scans with the extraoral scan of the verified stone casts. \- Statistical analysis: Data will be collected, analysed, and then tabulated.

Conditions

Edentulous Maxilla

Keywords

scanning of all on x maxillary dental implants

Outcome Measures

Primary Outcomes (1)

• assessment of accuracy of different intra oral scanning techniques versus the extraoral scanning method

  The primary outcome of this study is to evaluate and compare the accuracy of various intraoral scanning techniques against a benchmark established by an extraoral scanning method. Accuracy will be measured using parameters such as dimensional precision, surface detail reproduction, and alignment with reference models. The study aims to determine which intraoral scanning technique provides results that are statistically comparable to or exceed the accuracy of the extraoral method, thereby informing best practices in dental imaging.

  6 - 9 months

Study Arms (1)

patients rehabilitated with dental implants in upper edentulous jaws

EXPERIMENTAL

patients rehabilitated with dental implants in upper edentulous jaws, then different data acquisition techniques will be applied to the patients using conventional impressions versus intra-oral scanning methods

Device: extraoral versus intraoral scanning techniques

Interventions

extraoral versus intraoral scanning techniques DEVICE

different data acquisition techniques for full-arch dental implants

patients rehabilitated with dental implants in upper edentulous jaws

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Completely edentulous patients who had been wearing complete dentures and received 4 implants in the upper jaw.
• Patients with no systemic diseases affecting bone remodelling and osseointegration.
• Ridges showing well-keratinized mucosa.

You may not qualify if:

• Smokers.
• Non-compliant patients.
• Patients with systemic diseases that may affect bone remodelling and osseointegration.

Sponsors & Collaborators

• Misr University for Science and Technology: lead

Study Sites (1)

Misr University for Science and Technology

Giza, Giza Governorate, 12573, Egypt

Location

Study Officials

• HEBA ELSARRIF

  Misr University for Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Lecturer of Removable Prosthodontics

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: November 1, 2024
• Study Start: June 25, 2024
• Primary Completion: October 25, 2024
• Study Completion: December 25, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: April 2025
• Access Criteria: practitioners interested in the same field of research

Locations

EG (1)