Impression Technic, DentalNCT05545696
Artificial Intelligence Supported Intraoral Scanning.
A study testing AI on algorithm and AI off algorithm in people with Impression Technic, Dental, run by Kıvanç Akça at 1 site in Turkey (Türkiye).
Trial summary
Digitization (automation) of production stages with Computer-Aided Design and Computer-Aided Manufacturing (CAD/CAM) technologies has led to a digital revolution in dentistry, as in many other fields of the industry. In current dentistry, the digitalization process can be defined as direct and indirect workflow. Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Impression Technic, Dental
- What is being tested?
- AI on algorithm and AI off algorithm
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 5 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Volunteers who are not fulfilling the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Dentistry Department of Prosthodontics
Ankara, 06100
About this study
Official title: Comparison of Dental Arch Surface Scanning With and Without AI Support: A Methodological Study
Digitization (automation) of production stages with Computer-Aided Design and Computer-Aided Manufacturing (CAD/CAM) technologies has led to a digital revolution in dentistry, as in many other fields of the industry. In current dentistry, the digitalization process can be defined as direct and indirect workflow. The clinical reliability and success of the indirect digital workflow made possible by these technologies have been proven by scientific studies. With the development of intraoral scanners (IOS), a virtual model is obtained by direct digitalization. This method eliminated the conventıonale impression and dental cast model steps required for indirect digitalization. Intraoral scanners are used as an alternative to convantıonal impressions in single and short edentulous cases. It has already been emphasized that direct digitalization is a reliable alternative to the conventional impression method, as the clinical applicability, accuracy, and precision of the manufactured restorations have been scientifically verified. Therefore, the clinical use of direct digitalization is increasing (exponentially) day by day, and new upgraded versions of software, along with various modifications for the hardware equipment, are being developed. Integrating artificial intelligence (AI) supported software into the intraoral scanning process can be seen as the beginning of a new era for direct digitalization. Therefore the aim of this study is to evaluate the effect of artificial intelligence on the scanning time, the amount of data collected, and the image accuracy obtained.
Read the 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).
- Conditions
- Impression Technic, Dental
- Being tested
- AI on algorithm, AI off algorithm
- Keywords
- intraoral scanner, digitalization, Artificial intelligence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI on algorithmDevice
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.
AI off algorithmDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| AI on scanning | Sham comparator | 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. Receives: Device: AI on algorithm |
| AI off scanning | Active comparator | 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. Receives: Device: AI off algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scanning time and collected data
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.
Measured: during the intraoral scanning
Secondary outcomes (1)
Surface area measurment of triangles
The area data of the triangular objects obtained during both scans were calculated in a computer environment with reverse engineering software.
Measured: through study completion, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start1 Sep 2021
- Primary completion10 Oct 2021
- Study completion5 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impression Technic, DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kıvanç Akça
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Sponsor-investigator, Kıvanç Akça, Hacettepe University
- Investigators
- Kivanc Akca, Professor, Study director, Study Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545696
- Sponsor's protocol ID
- KA-21086
- Status last verified
- Sep 2022
- First submitted
- 26 May 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dental Arch Surface Scanning With and Without AI Support: A Methodological Study
- ClinicalTrials.gov ID
- NCT05545696
- Acronym / sponsor ID
- KA-21086
- Conditions
- Impression Technic, Dental
- Keywords
- intraoral scanner, digitalization, Artificial intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Kıvanç AkçaUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 10 Oct 2021 (actual)
- Study completion
- 5 Dec 2021 (actual)
- First posted
- 19 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Digitization (automation) of production stages with Computer-Aided Design and Computer-Aided Manufacturing (CAD/CAM) technologies has led to a digital revolution in dentistry, as in many other fields of the industry. In current dentistry, the digitalization process can be defined as direct and indirect workflow. The clinical reliability and success of the indirect digital workflow made possible by these technologies have been proven by scientific studies. With the development of intraoral scanners (IOS), a virtual model is obtained by direct digitalization. This method eliminated the conventıonale impression and dental cast model steps required for indirect digitalization. Intraoral scanners are used as an alternative to convantıonal impressions in single and short edentulous cases. It has already been emphasized that direct digitalization is a reliable alternative to the conventional impression method, as the clinical applicability, accuracy, and precision of the manufactured restorations have been scientifically verified. Therefore, the clinical use of direct digitalization is increasing (exponentially) day by day, and new upgraded versions of software, along with various modifications for the hardware equipment, are being developed. Integrating artificial intelligence (AI) supported software into the intraoral scanning process can be seen as the beginning of a new era for direct digitalization. Therefore the aim of this study is to evaluate the effect of artificial intelligence on the scanning time, the amount of data collected, and the image accuracy obtained.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI on scanning | Sham comparator | Device: AI on algorithmThe 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. |
| AI off scanning | Active comparator | Device: AI off algorithmThe 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. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Volunteers who are not fulfilling the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI on algorithmThe 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. | Device | AI on scanning |
| AI off algorithmThe 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. | Device | AI off scanning |
Primary outcome
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.
1 secondary outcome
Surface area measurment of triangles
Time frame: through study completion, an average of 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kivanc Akca, Professor study director
Study Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI on algorithm and AI off algorithm in people with Impression Technic, Dental, run by Kıvanç Akça at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scanning time and collected data (time frame: during the intraoral scanning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.