Accuracy of Intraoral Photogrammetry Scanner in Complete Arch Digital Implant Impression

NCT06599294 | Completed Phase 1 DMC

• 1 other identifier: 112899
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Intra oral scanning can perform a full digital workflow right on the patient's mouth. Recently an intra-oral photogrammetry scanner has been introduced in the market that can make intra-oral tissue scanning in addition to a built-in photogrammetry technology so that it can capture fixture locations through special intra-oral scan flags.

Conditions

Dental Implant

Keywords

Digital; photogrammetry; Intra oral scanner

Outcome Measures

Primary Outcomes (1)

• Degree of Trueness

  The clinical performance of conventional intraoral scanners (IOS) and intraoral photogrammetry scanners (IPS) for each patient enrolled in the study with a paired comparison of the deviation differences

  4 months following implant insertion

Study Arms (2)

intraoral photogrammetry scanning

EXPERIMENTAL

Procedure: Digital scanning; Procedure: Two digital impressions will be recorded, one with a conventional intra-oral scanner and another one with an intra-oral photogrammetry scanner.

Intra oral scanning

ACTIVE COMPARATOR

Procedure: Digital scanning; Procedure: Two digital impressions will be recorded, one with a conventional intra-oral scanner and another one with an intra-oral photogrammetry scanner.

Interventions

Digital scanning PROCEDURE

. For each patient three digital files will be obtained: One reference scan, one conventional IOS scan, and one IPS scan. All the STL files will be imported to dental CAD software, and scan bodies will be converted to implant multi-unit ti-base using a digital library. The updated STL files will be imported to inspection software Mimics for trueness assessments. The three-dimensional discrepancy between 2 STL files will be evaluated in terms of linear and angular deviation. A central point \& central axis of the virtual MUA ti-base was used for deviation measurements. Linear deviations will be assessed for each MUA tibase on the three-space axis (X longitudinal, Y lateral, and Z vertical) using the center of the ti-base heads for the deviation measurement. Angular deviations were assessed as the angles formed by the two lines passing perpendicularly through the centers of the test image and the reference image of each ti-base.

Intra oral scanning; intraoral photogrammetry scanning

Two digital impressions will be recorded, one with a conventional intra-oral scanner and another one with an intra-oral photogrammetry scanner. PROCEDURE

. For each patient three digital files will be obtained: One reference scan, one conventional IOS scan, and one IPS scan. All the STL files will be imported to dental CAD software, and scan bodies will be converted to implant multi-unit ti-base using a digital library. The updated STL files will be imported to inspection software Mimics for trueness assessments. The three-dimensional discrepancy between 2 STL files will be evaluated in terms of linear and angular deviation. A central point \& central axis of the virtual MUA ti-base was used for deviation measurements. Linear deviations will be assessed for each MUA tibase on the three-space axis (X longitudinal, Y lateral, and Z vertical) using the center of the ti-base heads for the deviation measurement. Angular deviations were assessed as the angles formed by the two lines passing perpendicularly through the centers of the test image and the reference image of each ti-base.

Intra oral scanning; intraoral photogrammetry scanning

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• participants had received 4-6 implants in 1 edentulous arch.
• Participants had received 1-piece implant-supported complete-arch fixed dental prostheses.

You may not qualify if:

• Systemic conditions as diabetes.
• Osteoporosis patients.
• Immunocompromised patients.

Sponsors & Collaborators

• Ain Shams University: lead
• Assiut University: collaborator

Study Sites (2)

Faculty of Dentistry Ain Shams University

Cairo, Abbassia, 11566, Egypt

Location

Faculty of Dentistry Ain Shams University

Cairo, Abbassia, 15666, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 7, 2024
• First Posted: September 19, 2024
• Study Start: June 20, 2024
• Primary Completion: August 10, 2024
• Study Completion: August 20, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)