NCT05545696

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

1 month

First QC Date

May 26, 2022

Last Update Submit

September 16, 2022

Conditions

Keywords

intraoral scannerdigitalizationArtificial intelligence

Outcome Measures

Primary Outcomes (1)

  • 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.

    during the intraoral scanning

Secondary Outcomes (1)

  • Surface area measurment of triangles

    through study completion, an average of 2 weeks

Study Arms (2)

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.

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.

Device: AI off algorithm

Interventions

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 on scanning

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.

AI off scanning

Eligibility Criteria

Age18 Years - 44 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Faculty of Dentistry Department of Prosthodontics

Ankara, 06100, Turkey (Türkiye)

Location

Study Officials

  • Kivanc Akca, Professor

    Study Director

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

May 26, 2022

First Posted

September 19, 2022

Study Start

September 1, 2021

Primary Completion

October 10, 2021

Study Completion

December 5, 2021

Last Updated

September 19, 2022

Record last verified: 2022-09

Locations