Silver Nanoparticle-Coated Orthodontic Brackets for Preventing Enamel Demineralization

NCT07707336 — Not applicable, Completed, 16 participants, Ajman University

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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

RegistryNCT07707336, acronym AgBracket
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, crossover, masking: double, prevention
Enrollment16 (Actual)
SponsorAjman University (Other)
ConditionsEnamel Demineralization, White Spot Lesions
InterventionsSilver Nanoparticle-Coated Stainless Steel Orthodontic Brackets, Conventional Stainless Steel Orthodontic Brackets (Device)
Datesstart 2024-09-20, primary completion 2025-04-29, completion 2025-05-23, first posted 2026-07-16, last updated 2026-07-16
Locations1 site in United Arab Emirates

Related Papers Related Patents Related Grants Related Experts
All trials for Enamel Demineralization All trials for White Spot Lesions All trials of Silver Nanoparticle-Coated Stainless Steel Orthodontic Brackets All trials of Conventional Stainless Steel Orthodontic Brackets

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Silver Nanoparticle-Coated Brackets on Randomized SideExperimentalDevice: Silver Nanoparticle-Coated Stainless Steel Orthodontic BracketsParticipants 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.
Conventional Brackets on Randomized SideActive comparatorDevice: Conventional Stainless Steel Orthodontic BracketsParticipants 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.
  • Silver Nanoparticle-Coated Stainless Steel Orthodontic Brackets (Device): 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.
  • Conventional Stainless Steel Orthodontic Brackets (Device): 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.

+Outcome measures

Primary outcomes

  • Calcium-to-Phosphorus Ratio of Enamel Adjacent to Orthodontic Brackets [One month after bracket placement]: 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.

Secondary outcomes

  • Enamel Surface Morphological Characteristics Adjacent to Orthodontic Brackets [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.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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.)

+Locations (1)

FacilityCityCountryStatus
Ajman UniversityAjmanUnited Arab Emirates

+Investigators