NCT07608471

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

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Jul 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Jul 2026Apr 2027

First Submitted

Initial submission to the registry

May 14, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 21, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2027

Last Updated

May 27, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

May 14, 2026

Last Update Submit

May 20, 2026

Conditions

Keywords

Dental CariesDental Caries White Spot LesionsCaries Lesion ActivityPost-Orthodontic Enamel Demineralization

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

Age11 Years - 46 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

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

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

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.