- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07320729
Accuracy of Intraoral Photogrammetry vs Optical Scanners for Immediate Full-Arch Implant Loading
Can Intraoral Photogrammetry Overcome Surgical Field Challenges? An In-Vivo Accuracy Study in Immediate Full-Arch Loading
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Digital impression systems are widely used for implant dentistry, but complete-arch implant scans remain challenging due to lack of stable landmarks and intraoral movement. Photogrammetry technology captures implant coordinates with high trueness by eliminating stitching errors and excluding unstable soft tissue. A newly introduced intraoral photogrammetry scanner (IPS) integrates photogrammetry and intraoral imaging in a single device.
This study is the first in-vivo prospective clinical trial comparing IOS and IPS accuracy in immediate complete-arch implant loading. Patients receiving 4-6 implants in one arch will undergo two digital impressions immediately after surgery: one using IOS (AoralScan 3) and one using IPS (Elite). A conventional splinted open-tray impression at second-stage surgery will be used as the reference model. Digital files will be superimposed to calculate linear, angular, and 3D (Euclidean) deviations. Scanning time and effect of arch type will also be evaluated.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Asyut Governorate
-
Asyut, Asyut Governorate, Egypt, 71111
- Assiut University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Completely edentulous arch to receive 4-6 implants. Candidate for immediate loading with a one-piece fixed prosthesis. ASA I or II medically healthy patients. Patient able to attend follow-up visits and sign informed consent.
Exclusion Criteria:
Medically compromised patients (ASA III or higher). Poor oral hygiene or heavy smokers. Insufficient bone volume for implant placement. Uncooperative patients or those refusing participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intraoral Optical Scanner (IOS)
Participants will undergo a digital implant impression using a conventional intraoral optical scanner immediately after implant placement to capture implant positions for immediate full-arch loading.
|
Digital intraoral scanning of implant positions using standard scan bodies for complete-arch implant impressions.
|
|
Experimental: Intraoral Photogrammetry Scanner (IPS)
Participants will undergo a digital implant impression using an intraoral photogrammetry scanner immediately after implant placement to capture implant coordinates using photogrammetric scan flags combined with intraoral soft tissue scanning.
|
Intraoral photogrammetric capture of implant coordinates using scan flags, combined with soft tissue scanning, without stitching.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trueness of Implant Position (3D Euclidean Deviation)
Time Frame: 3 Months
|
The primary outcome is to evaluate the clinical performance of conventional intraoral scanners (IOS) and intraoral photogrammetry scanners (IPS) in immediate complete arch implant loading for each patient enrolled in the study, with a paired comparison of the deviation differences (Degree of Trueness).
|
3 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of Arch Type on Digital Impression Trueness
Time Frame: 3 Months
|
The secondary outcome is to analyze the potential effect (correlation) of the type of arch (maxilla vs. mandible) on the degree of trueness.
Also, the scanning time of the 2 techniques will be compared.
|
3 Months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 17-2025-00027
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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