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
| Registry | NCT07707336, acronym AgBracket |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: double, prevention |
| Enrollment | 16 (Actual) |
| Sponsor | Ajman University (Other) |
| Conditions | Enamel Demineralization, White Spot Lesions |
| Interventions | Silver Nanoparticle-Coated Stainless Steel Orthodontic Brackets, Conventional Stainless Steel Orthodontic Brackets (Device) |
| Dates | start 2024-09-20, primary completion 2025-04-29, completion 2025-05-23, first posted 2026-07-16, last updated 2026-07-16 |
| Locations | 1 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
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Silver Nanoparticle-Coated Brackets on Randomized Side | Experimental | Device: Silver Nanoparticle-Coated Stainless Steel Orthodontic Brackets | 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. |
| Conventional Brackets on Randomized Side | Active comparator | Device: Conventional Stainless Steel Orthodontic Brackets | 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. |
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.)
| Facility | City | Country | Status |
|---|---|---|---|
| Ajman University | Ajman | United Arab Emirates |