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Silver Nanoparticle-Coated Orthodontic Brackets for Preventing Enamel Demineralization

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07707336
Acronym
AgBracket
Enrollment
16
Registered
2026-07-16
Start date
2024-09-20
Completion date
2025-05-23
Last updated
2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enamel Demineralization, White Spot Lesions

Keywords

Enamel Demineralization, Silver Nanoparticles, Stainless Steel Brackets, Scanning Electron Microscopy, Energy-Dispersive X-ray Spectroscopy, White Spot Lesions, Orthodontics, Randomized Clinical Trial

Brief summary

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.

Detailed description

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.

Interventions

DEVICESilver Nanoparticle-Coated Stainless Steel Orthodontic Brackets

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.

DEVICEConventional Stainless Steel Orthodontic Brackets

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.

Sponsors

Ajman University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

This study used a randomized split-mouth design. Each participant received both silver nanoparticle-coated stainless steel brackets and conventional stainless steel brackets on contralateral premolars, allowing each participant to serve as their own control.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.)

Design outcomes

Primary

MeasureTime frameDescription
Calcium-to-Phosphorus Ratio of Enamel Adjacent to Orthodontic BracketsOne month after bracket placementThe 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.

Secondary

MeasureTime frameDescription
Enamel Surface Morphological Characteristics Adjacent to Orthodontic BracketsOne month after bracket placementEnamel 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.

Countries

United Arab Emirates

Contacts

PRINCIPAL_INVESTIGATORJeny M George, MDS

Ajman University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026