Silver Nanoparticle-Coated Orthodontic Brackets for Preventing Enamel Demineralization (AgBracket)
Evaluating the Effectiveness of Silver Nanoparticle-Coated Stainless Steel Brackets in Preventing Enamel Demineralization in Patients Undergoing Fixed Orthodontic Treatment: A Randomised Split-Mouth Clinical Trial
The goal of this clinical trial is to learn whether orthodontic brackets coated with silver nanoparticles can help prevent early damage to tooth enamel in people receiving fixed braces.
The main question it aims to answer is:
-Do silver nanoparticle-coated brackets help reduce enamel demineralization (the early stage of tooth decay) compared with standard stainless steel brackets?
Researchers will compare silver nanoparticle-coated brackets with standard stainless steel brackets. Each participant will receive both types of brackets on different teeth so that the results can be compared within the same person.
Participants will:
- Receive fixed orthodontic treatment as planned.
- Have both silver nanoparticle-coated and standard stainless steel brackets placed on different teeth.
- Attend routine orthodontic appointments.
- Have premolar teeth that were already planned for extraction as part of their orthodontic treatment removed after one month so researchers can examine the tooth enamel around the brackets.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Enamel demineralization is a common complication of fixed orthodontic treatment because dental plaque can accumulate around orthodontic brackets. Silver nanoparticles have demonstrated antimicrobial properties and may help reduce bacterial growth around brackets, potentially decreasing the risk of enamel demineralization.
This randomized split-mouth clinical trial aims to evaluate the effectiveness of silver nanoparticle-coated stainless steel orthodontic brackets in preventing enamel demineralization compared with conventional stainless steel brackets in participants undergoing fixed orthodontic treatment requiring premolar extractions.
Participants will receive both silver nanoparticle-coated and conventional brackets on contralateral premolars according to a randomized allocation. The split-mouth design allows each participant to serve as their own control, reducing the influence of individual differences in oral hygiene, diet, and saliva composition.
After one month of orthodontic treatment, premolars that were already planned for extraction as part of the participants' orthodontic treatment will be removed. Enamel adjacent to the brackets will be evaluated using scanning electron microscopy (SEM) and energy-dispersive X-ray spectroscopy (EDS) to assess surface characteristics and mineral content. The findings will be used to compare the effectiveness of silver nanoparticle-coated and conventional brackets in reducing enamel demineralization during fixed orthodontic treatment.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Ajman, Forenede Arabiske Emirater
- Ajman University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Patients scheduled for fixed orthodontic treatment requiring premolar extraction
- No history of previous orthodontic treatment done
- Intact enamel surface of the premolars to be extracted
Exclusion Criteria:
- Non-extraction cases
- Patients with previously done orthodontic treatment
- Enamel surface defects on the premolars to be extracted(caries, hypoplasia, cracks etc.)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Silver Nanoparticle-Coated Brackets on Randomized Side
Participants received silver nanoparticle-coated stainless steel orthodontic brackets on one randomly assigned side of the mouth and conventional stainless steel orthodontic brackets on the contralateral side during fixed orthodontic treatment.
The intervention remained in place for one month before the planned extraction of the premolars for enamel evaluation.
|
Stainless steel orthodontic brackets coated with silver nanoparticles were bonded to randomly assigned premolars during fixed orthodontic treatment and remained in place for one month before the planned extraction of the premolars for enamel evaluation.
|
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Aktiv komparator: Conventional Brackets on Randomized Side
Participants received conventional stainless steel orthodontic brackets on one randomly assigned side of the mouth and silver nanoparticle-coated stainless steel orthodontic brackets on the contralateral side during fixed orthodontic treatment.
The intervention remained in place for one month before the planned extraction of the premolars for enamel evaluation.
|
Conventional stainless steel orthodontic brackets were bonded to the contralateral premolars during fixed orthodontic treatment and remained in place for one month before the planned extraction of the premolars for enamel evaluation.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Calcium-to-Phosphorus Ratio of Enamel Adjacent to Orthodontic Brackets
Tidsramme: One month after bracket placement
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The calcium-to-phosphorus (Ca/P) ratio of enamel adjacent to silver nanoparticle-coated and conventional stainless steel orthodontic brackets will be measured using energy-dispersive X-ray spectroscopy (EDS).
The mean Ca/P ratio will be compared between the two bracket types.
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One month after bracket placement
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Enamel Surface Morphological Characteristics Adjacent to Orthodontic Brackets
Tidsramme: One month after bracket placement
|
Enamel surface morphology adjacent to silver nanoparticle-coated and conventional stainless steel orthodontic brackets will be evaluated using scanning electron microscopy (SEM).
Representative SEM images will be analyzed descriptively to assess differences in enamel surface appearance between the two bracket types.
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One month after bracket placement
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Jeny M George, MDS, Ajman University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- D-F-H-24-11-18-b
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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