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

NCT06829550 | Completed FDA Device

• 1 other identifier: 24373
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Caries in Children; Tooth Erosion; Fluorosis, Dental; Dental Caries

Keywords

scanning for dental problems; computer-assisted image processing; tooth wear; dental fluorosis; intraoral scanner; dental caries; dental decay; tooth erosion

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

direct- visual examination and indirect- 3D digital scanning

OTHER

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

Interventions

indirect- 3D digital scanning DIAGNOSTIC_TEST

examination for dental caries, erosive tooth wear and dental fluorosis using direct assessment (visual) and indirect assessment (digital scanning)

direct- visual examination and indirect- 3D digital scanning

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University School of Dentistry (IUSD)

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Tooth Erosion; Fluorosis, Dental; Dental Caries; Tooth Wear

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Aline Castilho, DDS

  Indiana Unviersity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 17, 2025
• Study Start: November 4, 2025
• Primary Completion: December 10, 2025
• Study Completion: December 10, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)