- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05545696
Artificial Intelligence Supported Intraoral Scanning.
Comparison of Dental Arch Surface Scanning With and Without AI Support: A Methodological Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
It was planned intraoral scanning (3Shape TRIOS A/S, Copenhagen, Denmark) of the participants' mandible (n=21) with artificial intelligence (AI on) and without artificial intelligence (AI off). Reference equilateral triangles for scanning were digitally designed and produced with a 3D printer. Then these triangles bonded to the buccal surfaces of #34, #44, and the lingual surfaces of #36#46 teeth. The lower jaw of each participant was scanned by the same operator, in line with the recommended scanning protocol. Furthermore, scanning was performed randomly, with AI on and off.
The IOS software automatically recorded the data required for quantitative comparing the scanning time and the obtained images (TRIOS Scanning Version 1.18.310, 3Shape A/S). In order to compare the scanning effectiveness between the methods, the area data of the digital images of the triangular objects obtained during both scans were calculated in a computer environment with reverse engineering software (Geomagic design X version 2016.1.0, 3D Systems Inc. Rock Hill, SC).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey, 06100
- Hacettepe University Faculty of Dentistry Department of Prosthodontics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Completed growth and development
- Good oral hygiene habits and healthy periodontal status.
- Absence of missing teeth in mandibula (or no teeth loss in mandibular)
- Signing of the informed consent form
- No temporomandibular joint (TMJ) disorder
Exclusion Criteria:
- Volunteers who are not fulfilling the inclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
SHAM_COMPARATOR: AI on scanning
The lower jaw of the participants was scanned with ''AI on'' scanning in line with recommended scanning protocol, and the IOS software automatically recorded the obtained data.
|
The mandibles of the participants were scanned with ''AI on'' scanning in line with the recommended scanning protocol.
All scans were performed by the same operator.
|
|
ACTIVE_COMPARATOR: AI off scanning
The lower jaw of the participants was scanned with ''AI off'' scanning in line with recommended scanning protocol, and the IOS software automatically recorded the obtained data.
|
The mandibles of the participants were scanned with ''AI off'' scanning in line with the recommended scanning protocol.
All scans were performed by the same operator.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Scanning time and collected data
Time Frame: during the intraoral scanning
|
The scanning time (in minutes and seconds) and the amount of collected data (as the count of images), automatically recorded by the intraoral scanning software, will be used to compare the two scanning methods.
|
during the intraoral scanning
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surface area measurment of triangles
Time Frame: through study completion, an average of 2 weeks
|
The area data of the triangular objects obtained during both scans were calculated in a computer environment with reverse engineering software.
|
through study completion, an average of 2 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Kivanc Akca, Professor, Study Director
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 (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
- KA-21086
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.