3D Scanning as an Advanced Tool for Identifying Tooth Lesions in Children
NCT ID: NCT06829550
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
NA
30 participants
INTERVENTIONAL
2025-11-04
2026-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The visual examination and digital scanning will be performed just once and during the dental appointment at the clinic of Pediatric Dentistry following the protocols used in the clinical routine. It is expected to complete the visual examination and the digital scanning in 30 minutes.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patient recruitment: The research protocol was approved by the Institutional Review Board (# 24373). After IRB approval and previous to any intervention, a signed informed consent form will be obtained from the legal guardians of each child. Children aged between 3 and 12 years old, presenting any fully erupted primary teeth, searching for dental treatment at the Department of Pediatric Dentistry, Indiana University School of Dentistry will be included in this study.
Visual examination: Before visual examination, teeth will be cleaned using a bristle brush, prophylaxis paste and mirror, washed, and carefully air dried. Isolator will be used to control the saliva during the prophy. For the index detection using the visual examination of the different indices on each tooth's, the primary upper and lower incisors, canines and molars will be dried with compressed air, and each tooth's buccal, palatal/lingual, and occlusal surfaces will be examined visually using adequate dental instruments for each index. A headlight or overhead/dental unit light will be directly over the teeth. The diagnosis of caries lesions, erosive tooth wear, and dental fluorosis will be carried out separately. ICDAS, BEWE, and TF systems will be registered and graded the lesions according to table 1. Once the visual examination is completed, the data will be stored to be compared with intraoral scanner later.
Digital scanning: After completing the visual examination, the investigators will be calibrated using 3Shape TRIOS 4 intraoral scanner and 3Shape Unite software for data processing according to the manufacturer's instructions. The primary teeth's buccal, palatal/lingual, and occlusal surfaces will be scanned with a 3D intraoral scanner (IOS) (TRIOS 4; 3Shape A/S, Copenhagen, Denmark) and register with a number. There will be no headlight or overhead/dental unit light directly over the teeth to be scanned. Subsequently, using the 3Shape Unite software, each tooth will be analyzed separately on all its surfaces (as with the visual examination, the ICDAS, BEWE, and TF, indices will be detected) by using the 3Shape software and an entire screen of a 15.5" Dell laptop. Following, the 3D image will be magnified until only lesion can be seen and each surface will be observed systematically for each index.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
direct- visual examination and indirect- 3D digital scanning
Two diagnostic methods (direct- visual examination and indirect- 3D digital scanning) will be conducted for each participant (n=30), comparing their effectiveness in detecting dental caries, erosive tooth wear, and fluorosis.
indirect- 3D digital scanning
examination for dental caries, erosive tooth wear and dental fluorosis using direct assessment (visual) and indirect assessment (digital scanning)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
indirect- 3D digital scanning
examination for dental caries, erosive tooth wear and dental fluorosis using direct assessment (visual) and indirect assessment (digital scanning)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Restored teeth.
* Children under 3 or older than 12 years old.
* Children using medication.
3 Years
12 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Indiana University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Aline Rogeria Freire de Castilho
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Aline Castilho, DDS
Role: PRINCIPAL_INVESTIGATOR
Indiana Unviersity
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Indiana University School of Dentistry (IUSD)
Indianapolis, Indiana, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
24373
Identifier Type: -
Identifier Source: org_study_id