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Not yet recruitingNCT07608471Updated May 27, 2026

QLF and Digital Imaging for Caries Activity Assessment After Orthodontic Treatment

An observational study in Dental Caries, White Spot Lesions and Caries Lesion Activity, sponsored by Universidad El Bosque, Bogotá. Not yet recruiting. Open to participants aged 11 Years to 46 Years. Per ClinicalTrials.gov, last updated 2026-05-27.

Sponsored by Universidad El Bosque, Bogotá · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
11 Years to 46 Years
Sex
All
01

Study summary

This prospective longitudinal observational study aims to evaluate the diagnostic performance and agreement of Smartphone photography, intraoral 3D imaging, Quantitative Light-Induced Fluorescence Digital (QLF-D), and ICDAS clinical criteria for assessing non-cavitated caries lesion activity in post-orthodontic patients under a preventive follow-up program. Thirty participants aged 11 to 46 years with active initial caries lesions will be followed for three months. Clinical examinations, QLF-D imaging, smartphone photographs, and intraoral 3D scans will be obtained at baseline and follow-up visits combined with professional prophylaxis and oral hygiene reinforcement. The study will analyze changes in lesion activity, fluorescence parameters, and surface characteristics over time, as well as the agreement and diagnostic performance among the evaluated methods.

Read the detailed description

This prospective longitudinal observational study will evaluate the agreement and diagnostic performance of Smartphone photography, intraoral 3D imaging, Quantitative Light-Induced Fluorescence Digital (QLF-D), and ICDAS clinical criteria for assessing non-cavitated caries lesion activity in post-orthodontic patients.

Participants presenting active initial caries lesions on vestibular tooth surfaces will undergo clinical examinations, QLF-D imaging, smartphone photographs, and intraoral 3D scans at baseline and during a three-month preventive follow-up program. Professional prophylaxis and oral hygiene reinforcement will be performed throughout the study period.

Changes in clinical lesion activity, fluorescence parameters, and topographic characteristics will be analyzed to determine the monitoring capacity, agreement, and diagnostic performance of the evaluated methods. Patient acceptance of the diagnostic technologies will also be assessed.

02

Conditions studied

  • Dental Caries
  • White Spot Lesions
  • Caries Lesion Activity
  • Post-Orthodontic Enamel Demineralization

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Keywords

  • Dental Caries
  • Dental Caries White Spot Lesions
  • Caries Lesion Activity
  • Post-Orthodontic Enamel Demineralization
03

In context

Dental Caries

1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.

This study's planned enrollment of 30 is below the median of 174 across 187 observational studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

Universidad El Bosque, Bogotá is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 46 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will include post-orthodontic patients from Bogotá, Colombia, aged 11 to 46 years, presenting active non-cavitated caries lesions on vestibular tooth surfaces. Participants will be recruited from university clinical settings and enrolled in a preventive follow-up program involving clinical and digital caries assessment methods.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants aged 11 to 46 years
  • Completed fixed orthodontic treatment
  • Presence of at least four active non-cavitated caries lesions (ICDAS 1-3)
  • Lesions located on vestibular surfaces of anterior teeth and/or premolars
  • Ability to attend follow-up visits during the three-month study period
  • Signed and/or assent form

Exclusion criteria

Exclusion Criteria:

  • Systemic conditions affecting salivary flow or enamel structure
  • Extensive cavitated lesions requiring restorative treatment
  • Ongoing orthodontic treatment
  • Use of medications that significantly affect oral conditions
  • Inability to cooperate with imaging procedures or follow-up visits
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • Post-Orthodontic Patients With Non-Cavitated Caries Lesions

    Participants aged 11 to 46 years who have completed fixed orthodontic treatment and present at least four active non-cavitated caries lesions (ICDAS 1-3) on vestibular surfaces of anterior teeth or premolars. Participants will undergo clinical assessment using ICDAS criteria, QLF-D imaging, smartphone photography, and intraoral 3D scanning during a three-month preventive follow-up program that includes professional prophylaxis and oral hygiene reinforcement.

06

What researchers measure

Primary outcomes

  1. Diagnostic Agreement Measured by Weighted Kappa Between ICDAS Clinical Assessment and QLF-D, Smartphone Photography, and Intraoral 3D Imaging for Non-Cavitated Caries Lesion Activity

    Diagnostic agreement among ICDAS clinical criteria, QLF-D fluorescence parameters, smartphone intraoral photographs, and intraoral 3D imaging for identifying active and inactive non-cavitated caries lesions in post-orthodontic patients.

    Time frame: Baseline, 3 months and 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared due to confidentiality and privacy considerations related to clinical images and personal health information collected during the study. De-identified aggregate results will be reported in scientific publications and presentations.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07608471
Lead sponsor
Universidad El Bosque, Bogotá
Responsible party
Andrea Cortes (PhD, Universidad El Bosque, Bogotá) — Principal investigator
First posted
May 27, 2026
Start date
Jul 21, 2026 (estimated)
Primary completion
Dec 4, 2026 (estimated)
Completion
Apr 22, 2027 (estimated)
Last update
May 27, 2026

Study contacts

Andrea Cortes, PhD
Contact
cortesandrea@unbosque.edu.co
312 3654862

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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