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The Effect of Nano Chitosan Surface Coating on White Spot Lesions Development in Clear Aligner Therapy Patients

16. juli 2026 opdateret af: Jordan University of Science and Technology

The Effect of Nano Chitosan Carboxymethyle Methyle Cellulose Surface Coating on White Spot Lesions Development in Patients With Clear Aligner Therapy: Prospective Randomized Controlled Clinical Trial

In this study, it was intended to investigate the effect of nano Chitosan (antimicrobial agent) coating on clear aligner orthodontic appliance if it reduces the incidence of white spot lesions (demineralization) of enamel surfaces.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

White spot lesions (WSLs) are a common complication of orthodontic treatment and represent the earliest stage of enamel demineralization. Although clear aligner therapy is generally associated with a lower risk of WSL development than fixed appliances, enamel demineralization may still occur during treatment. Chitosan nanoparticles possess antimicrobial properties and have shown potential for preventive dental applications. This study investigated the effectiveness of chitosan nanoparticle-coated clear aligners in limiting enamel demineralization during orthodontic treatment.

A prospective two-arm parallel-group randomized controlled clinical trial was conducted on 53 patients (18-29 years) undergoing clear aligner therapy. Participants were randomly allocated into two groups: conventional clear aligners (control) and chitosan nanoparticle-coated clear aligners (experimental). Three participants were lost to follow-up, and 50 patients (25 per group) were included in the final analysis. Chitosan nanoparticles were prepared using ionic gelation and applied to aligner surfaces following atmospheric plasma treatment. Surface characterization was performed using profilometry, scanning electron microscopy (SEM), and energy-dispersive X-ray analysis (EDAX). White spot lesions were assessed at baseline and after six months using quantitative light-induced fluorescence (QLF)

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

53

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Jordan
      • Irbid, Jordan, 22110
        • Postgraduate Orthodontic Clinics

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

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Patients presenting with mild to moderate malocclusion (sagittal, vertical, transverse discrepancies, or crowding) that could be treated using clear aligners within a maximum treatment period of one year and without the need for extraction therapy.
  • Medically healthy patients with no systemic diseases or medical conditions that could affect enamel integrity, salivary flow, oral hygiene status, or periodontal health.
  • Patients with no history of previous orthodontic treatment, dental trauma, or parafunctional habits such as bruxism.
  • Patients with good oral hygiene and absence of active periodontal disease, including gingivitis or periodontitis.
  • Patients willing to comply with the prescribed clear aligner wear protocol for a minimum of 22 hours per day.
  • Patients who agreed to participate in the study and signed the informed consent form.

Exclusion Criteria:

  • Previous orthodontic treatment that could influence baseline enamel condition or white spot lesion assessment.
  • Presence of active carious lesions, cavitated lesions, severe enamel hypoplasia, or developmental enamel defects.
  • Extensive restorations on anterior teeth that could interfere with Quantitative Light-Induced Fluorescence (QLF) imaging and analysis.
  • Systemic diseases or medical conditions affecting salivary flow, enamel integrity, oral hygiene, or periodontal health.
  • Use of medications known to affect salivary secretion, enamel mineralization, or oral microbial balance.
  • Poor oral hygiene or presence of active periodontal disease, including gingivitis or periodontitis.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention
Chitosan nanoparticle coating of the clear orthodontic aligners that will be used by the participants
Andet: chitosan nanoparticles
Clear orthodontic aligners will be coated with nanoparticle sized Chitosan to investigate its anti-microbial effect on development of white spot lesions underneath the aligners
Placebo komparator: Control
The clear orthodontic aligners that will be used by the participants are not coated with anything.
Andet: No Treatment Added
No coating of the orthodontic aligners

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
White spot lesion area
Tidsramme: 3 months
It measures the area of enamel demineralization in pixels (Using the QLF system)
3 months
Mean of fluorescence loss (Delta F) in percent
Tidsramme: 3 months
It measures the percentage of fluorescence loss in the white spot lesion compared to that of sound enamel reflecting the amount of mineral loss using the QLF system
3 months

Samarbejdspartnere og efterforskere

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

Sponsor

Jordan University of Science and Technology

Samarbejdspartnere

Deanship of Scientific Research/Jordan University of Science and Technology

Efterforskere

  • Studieleder: Susan Al-Khateeb, Jordan University of Science and Technology

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 (Faktiske)

12. oktober 2025

Primær færdiggørelse (Faktiske)

30. juni 2026

Studieafslutning (Anslået)

29. oktober 2026

Datoer for studieregistrering

Først indsendt

7. juli 2026

Først indsendt, der opfyldte QC-kriterier

16. juli 2026

Først opslået (Faktiske)

20. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • JUST20250008

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

The data will be provided at reasonable request

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

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 .

Kliniske forsøg med Hvide pletlæsioner

Kliniske forsøg med chitosan nanoparticles

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Sponsorer og samarbejdspartnere

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Narkotikainterventioner

CROs by country

CROs in Morocco

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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