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Dental Caries in ChildrenNCT06829550

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

A study testing indirect- 3D digital scanning in people with Dental Caries in Children and Tooth Erosion, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?
Ages 3 to 12 yearsHealthy volunteers can take part
What is being tested?
indirect- 3D digital scanning
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
4 Nov 2025to 10 Dec 2025
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Indiana University School of Dentistry (IUSD)

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

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.

Read the 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.

Being tested
indirect- 3D digital scanning
Keywords
scanning for dental problems, computer-assisted image processing, tooth wear, dental fluorosis, intraoral scanner, dental caries, dental decay, tooth erosion
Medical subject headings
Tooth Erosion, Fluorosis, Dental, Dental Caries, Tooth Wear

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • indirect- 3D digital scanningDiagnostic test

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

Study groups in NCT06829550
Study groupRoleWhat they receive
direct- visual examination and indirect- 3D digital scanningOtherTwo 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.
Receives: Diagnostic Test: indirect- 3D digital scanning

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Evaluation will occur during the single 1 day visit

  2. 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

    Measured: Evaluation will occur during the single 1 day visit

  3. 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

    Measured: Evaluation will occur during the single 1 day visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2025
  2. Study start4 Nov 2025
  3. Primary completion10 Dec 2025
  4. Study completion10 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06829550
Sponsor's protocol ID
24373
Status last verified
May 2026
First submitted
5 Feb 2025
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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