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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silver Nanoparticle-Coated Brackets on Randomized Side | Experimental | 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. |
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| Conventional Brackets on Randomized Side | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Calcium-to-Phosphorus Ratio of Enamel Adjacent to Orthodontic Brackets | 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. | One month after bracket placement |
| Measure | Description | Time Frame |
|---|---|---|
| Enamel Surface Morphological Characteristics Adjacent to Orthodontic Brackets | 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. | One month after bracket placement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeny M George, MDS | Ajman University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ajman University | Ajman | United Arab Emirates |
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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.
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| 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. |
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