3D Scanning for Tooth Decay

Overseen By Lorena Galvez, CRC

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must not be taking: Any medication

Disqualifiers: Unerupted teeth, Restored teeth, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial excludes children who are using medication, so participants must not be on any current medications to join.

What data supports the effectiveness of the treatment 3D Digital Scanning for tooth decay?

Research shows that 3D dental models created with an intraoral scanner can effectively detect tooth decay, performing comparably to traditional visual inspections. This suggests that 3D digital scanning is a reliable method for identifying cavities. ^{1 2 3 4 5}

Is 3D scanning for tooth decay safe for humans?

The research on 3D scanning, including intraoral scanners, suggests it is generally safe for humans, as it involves no radiation exposure and minimal risk of soft tissue deformation. However, more clinical studies are needed to fully validate its safety and effectiveness in various dental applications. ^{3 6 7 8 9}

How does 3D Digital Scanning for Tooth Decay differ from other treatments?

3D Digital Scanning for Tooth Decay is unique because it uses advanced imaging technology to create detailed 3D models of teeth, allowing for precise detection and assessment of tooth decay without the need for traditional dental impressions or higher radiation doses from X-rays. This method offers a more accurate and non-invasive way to diagnose and monitor dental caries (tooth decay) compared to conventional methods. ^{1 2 10 11 12}

What is the purpose of this trial?

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.

Research Team

Aline Castilho, DDS

Principal Investigator

Indiana Unviersity

Eligibility Criteria

This trial is for children aged 3-12 with fully erupted primary teeth who are visiting the Pediatric Dentistry Department at Indiana University School of Dentistry. It's suitable for those needing dental checks or treatment.

Inclusion Criteria

My child is between 3 and 12 years old with at least one adult tooth.

Exclusion Criteria

Unerupted primary teeth

I have had dental work to restore my teeth.

My child is currently taking medication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Visual Examination

Teeth are cleaned and examined visually using dental tools and light to assess caries, erosive wear, and fluorosis

1 day

1 visit (in-person)

Digital Scanning

Teeth are scanned with a 3D intraoral scanner to validate findings from the visual examination

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate reactions or issues post-examination

1-2 weeks

Treatment Details

Interventions

• 3D Digital Scanning

Trial Overview The study tests a 3D intraoral digital scanner to identify tooth decay, wear, and fluorosis in kids' teeth. It compares visual examination results with scans using ICDAS, BEWE, and TF indices during a single clinic visit.

Participant Groups

Group I: direct- visual examination and indirect- 3D digital scanning Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Occlusal caries detection on 3D models obtained with an intraoral scanner. A validation study. [2023]

2. China pubmed.ncbi.nlm.nih.gov

[Evaluation of the quality of three-dimensional data acquired by using two kinds of structure light intra-oral scanner to scan the crown preparation model]. [2018]

3. Poland pubmed.ncbi.nlm.nih.gov

Accuracy of digital dental models using the low-cost DAVID laser scanner. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Linear and logarithmic subtraction for detecting enamel subsurface demineralization. [2016]

5. India pubmed.ncbi.nlm.nih.gov

Assessment of diagnostic accuracy of a direct digital radiographic-CMOS image with four types of filtered images for the detection of occlusal caries. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Expanding the Application of Digital Dentistry with 3D Patient Monitoring. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Accuracy and reliability of a novel method for fusion of digital dental casts and Cone Beam Computed Tomography scans. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Complete digital workflow for complete arch implant therapy: Fact or fiction? [2022]

9. England pubmed.ncbi.nlm.nih.gov

Efficacy of Constructing Digital Hybrid Skull-Dentition Images Using an Intraoral Scanner and Cone-Beam Computed Tomography. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Dental impressions using 3D digital scanners: virtual becomes reality. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Digital reconstruction of teeth using near-infrared light. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Investigation of a new light imaging technique to detect incipient caries in teeth. [2007]