Artificial Intelligence Supported Intraoral Scanning.

September 16, 2022 updated by: Kıvanç Akça

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University Faculty of Dentistry Department of Prosthodontics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 44 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: AI on algorithm
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.
Device: AI off algorithm
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kıvanç Akça

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hacettepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kivanc Akca, Professor, Study Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KA-21086

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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Conditions

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Dietary Supplements

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