QLF and Digital Imaging for Caries Activity Assessment After Orthodontic Treatment
Diagnostic Performance of Smartphone, 3D Imaging, QLF-D, and ICDAS Clinical Criteria for Non-Cavitated Caries Activity Assessment in Post-Orthodontic Patients Under a Preventive Program
1 other identifier
observational
30
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2026
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2026
CompletedFirst Posted
Study publicly available on registry
May 27, 2026
CompletedStudy Start
First participant enrolled
July 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 4, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 22, 2027
May 27, 2026
May 1, 2026
5 months
May 14, 2026
May 20, 2026
Conditions
Keywords
Outcome Measures
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.
Baseline, 3 months and 6 months
Study Arms (1)
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.
Eligibility Criteria
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.
You may qualify if:
- 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 informed consent and/or assent form
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
May 14, 2026
First Posted
May 27, 2026
Study Start
July 21, 2026
Primary Completion (Estimated)
December 4, 2026
Study Completion (Estimated)
April 22, 2027
Last Updated
May 27, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
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.