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3D Scanning and Transillumination vs Conventional Examination to Assess Caries Progression, Stability or Regression

NCT05409625 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-07-16

No results posted yet for this study

Summary

The objective of this study is to investigate whether the 3D scanner and accompanying software, as well as the transillumination method, can identify changes in primary caries lesions in caries-active patients, where selected lesions achieve a higher degree of plaque control than others over an 8-month period.

The working hypothesis of this study is that the two methods, scanning and transillumination, are as good as the traditional method (clinical examination complemented by radiographs) to assess whether caries lesions are progressing, stable or regressing. Progression, stability or regression of selected caries lesions are thus the endpoint, and the rationale is to investigate whether more objective measures can replace/supplement a subjective method to assess progression, stability or regression of caries lesions.

Conditions

  • Dental Caries

Interventions

DEVICE

Intraoral Scanner (TRIOS 4, 3Shape TRIOS A/S, Copenhagen, Denmark)

Intraoral scanner which is able to generate a 3D-model of the teeth and is being used for caries detection.

DEVICE

Intraoral camera (DIAGNOcam, KaVo, Biberach, Germany, software version 3.0.1/2.9.1)

Intraoral camera used for caries detection in the occlusal and proximal surfaces.

DEVICE

X-ray device (X-ray device SOREDEX, MINRAY®; Image plates VistaScan; Image plate scanner VistaScan Mini View, Dürr Dental)

X-ray device used for caries detection. Two radiographs (bitewings) are taken, one in each side.

PROCEDURE

Oral cleaning

Removal of tartar and plaque. Tartar removal done at baseline and the fifth visit, but only on selected teeth at the second, third and fourth visit. Regular cleaning with a toothbrush done at all visits.

Sponsors & Collaborators

  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Kim R. Ekstrand, ph.d · Institute of Odontology, University of Copenhagen

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-15
Primary Completion
2022-09-19
Completion
2022-09-19

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05409625 on ClinicalTrials.gov