- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06599294
Accuracy of Intraoral Photogrammetry Scanner in Complete Arch Digital Implant Impression
Accuracy of Intraoral Photogrammetry Scanner (IPS) in Complete Arch Digital Implant Impression: an in Vivo Prospective Comparative Study
Study Overview
Status
Conditions
Detailed Description
Intraoral scanning had several advantages to intraoral direct scanning, including less storage and transportation needs, faster scanning times, and increased patient comfort. The intraoral scan bodies are used as digital fixture locators when using IOSs for implant impressions.
Photogrammetry is the science and technology of obtaining reliable information about physical objects through the process of recording, measuring, and interpreting photographic images and patterns of electromagnetic radiant imagery. The utilization of photogrammetry in the dental field leads to exclusion of intraoral dental and gingival anatomies while scanning the implant coordinates. In addition, no need for stitching during full arch implant scanning which is reflected in the trueness and precision of the scanned object. Exclusion of unstable mucosa during scanning and avoidance of stitching make the passive seating of implant prosthesis a more predictable procedure especially when compared with intra-oral scanning only.
Up to this moment, all photogrammetry systems available in the market are considered extraoral systems that require an additional impression for soft tissue capture whether conventional or digital. Recently an intra-oral photogrammetry scanner (IPS) 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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Abbassia
-
Cairo, Abbassia, Egypt, 11566
- Faculty of dentistry Ain Shams University
-
Cairo, Abbassia, Egypt, 15666
- Faculty of dentistry Ain Shams University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- participants had received 4-6 implants in 1 edentulous arch.
- Participants had received 1-piece implant-supported complete-arch fixed dental prostheses.
Exclusion Criteria:
- Systemic conditions as diabetes.
- Osteoporosis patients.
- Immunocompromised patients.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intraoral photogrammetry scanning
|
. 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.
. 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.
|
|
Active Comparator: Intra oral scanning
|
. 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.
. 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of Trueness
Time Frame: 4 months following implant insertion
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 112899
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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