3D Scanning as an Advanced Tool for Identifying Tooth Lesions in Children

This study focuses on assessing dental caries, erosive tooth wear, and fluorosis in primary teeth using a 3D intraoral digital scanner. The investigator will validate findings using three key indices: ICDAS (for caries), BEWE (for erosive wear), and TF (for fluorosis). Teeth will be cleaned and examined visually using dental tools and light. After visual checks, teeth will be scanned with a 3D intraoral scanner. Children aged 3-12 years with fully erupted primary teeth, seeking dental treatment at the Department of Pediatric Dentistry, Indiana University School of Dentistry.

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries in Children; Dental Caries; Fluorosis, Dental; Tooth Erosion
• Intervention / Treatment: Diagnostic test: indirect- 3D digital scanning

Detailed Description

Experimental design: This study is based on information obtained in a pilot study in the framework of a "validation study" previously to an in vivo study. Investigators will be trained in 3 different indices to register and grade the lesions to obtain reproducible data. International caries detection and assessment system (ICDAS - Pitts et al., 2013), Basic Erosive Wear Examination (BEWE - Schlueter et al., 2020), and TF index (Thylstrup & Fejerskov, 1978) will be used for detection of caries lesions, erosive tooth wear, and dental fluorosis, respectively.

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Dentistry (IUSD)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Children aged between 3 and 12 years old, presenting at least one fully erupted primary tooth.

Exclusion Criteria:

• Unerupted primary teeth.
• Restored teeth.
• Children under 3 or older than 12 years old.
• Children using medication.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Diagnostic test: indirect- 3D digital scanning; examination for dental caries, erosive tooth wear and dental fluorosis using direct assessment (visual) and indirect assessment (digital scanning)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate caries using intraoral digital scanning	Dental caries - detection of caries lesions in primary teeth comparing the use of intraoral digital 3D scanning (imaging) to a traditional clinical exam	Evaluation will occur during the single 1 day visit
Evaluate Erosive tooth wear using digital scanning	Erosive Tooth Wear - detection of erosive tooth wear patterns in primary teeth comparing the use of intraoral digital 3D scanning (imaging) with a traditional clinical erosion tooth wear exam	Evaluation will occur during the single 1 day visit
Evaluate fluorosis using intraoral digital scanning	Fluorosis: - detection of fluorosis in primary teeth comparing the use of intraoral digital 3D scanning (imaging) with a traditional clinical fluorosis exam	Evaluation will occur during the single 1 day visit

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Aline Castilho, DDS, Indiana Unviersity

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2025
• Primary Completion (Actual): December 10, 2025
• Study Completion (Actual): December 10, 2025

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 14, 2025
• First Posted (Actual): February 17, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: dental caries; intraoral scanner; tooth wear; tooth erosion; dental fluorosis; dental decay; scanning for dental problems; computer-assisted image processing
• Additional Relevant MeSH Terms: Dental Enamel Hypomineralization; Developmental Defects of Enamel; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Tooth Demineralization; Tooth Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Tooth Erosion; Dental Caries; Tooth Wear; Fluorosis, Dental
• Other Study ID Numbers: 24373

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes