Dental CariesNCT07608471
QLF and Digital Imaging for Caries Activity Assessment After Orthodontic Treatment
An observational study of Dental Caries and White Spot Lesions, run by Universidad El Bosque, Bogotá.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 46 years
- Conditions the study is for
- Dental Caries, White Spot Lesions, Caries Lesion Activity
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 21 Jul 2026to 22 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 11 to 46 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
- Conditions
- Dental Caries, White Spot Lesions, Caries Lesion Activity, Post-Orthodontic Enamel Demineralization
- Keywords
- Dental Caries, Dental Caries White Spot Lesions, Caries Lesion Activity, Post-Orthodontic Enamel Demineralization
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start21 Jul 2026 (estimated)
- Primary completion4 Dec 2026 (estimated)
- Study completion22 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad El Bosque, Bogotá
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Cortes, Universidad El Bosque, Bogotá
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608471
- Sponsor's protocol ID
- UEB CIE2025-108
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07608471
- Acronym / sponsor ID
- UEB CIE2025-108
- Conditions
- Dental Caries, White Spot Lesions, Caries Lesion Activity, Post-Orthodontic Enamel Demineralization
- Keywords
- Dental Caries, Dental Caries White Spot Lesions, Caries Lesion Activity, Post-Orthodontic Enamel Demineralization
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad El Bosque, BogotáUniversity, hospital or other
- Study start
- 21 Jul 2026 (estimated)
- Primary completion
- 4 Dec 2026 (estimated)
- Study completion
- 22 Apr 2027 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 11 to 46 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: Baseline, 3 months and 6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries and White Spot Lesions, run by Universidad El Bosque, Bogotá.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Cortes, PhD (312 3654862, cortesandrea@unbosque.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline, 3 months and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.