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QLF and Digital Imaging for Caries Activity Assessment After Orthodontic Treatment

20. maj 2026 opdateret af: Andrea Cortes, Universidad El Bosque, Bogotá

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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

30

Kontakter og lokationer

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Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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 informed consent and/or assent form

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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.
Baseline, 3 months and 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

21. juli 2026

Primær færdiggørelse (Anslået)

4. december 2026

Studieafslutning (Anslået)

22. april 2027

Datoer for studieregistrering

Først indsendt

14. maj 2026

Først indsendt, der opfyldte QC-kriterier

20. maj 2026

Først opslået (Faktiske)

27. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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