Silver Nanoparticle-Coated Orthodontic Brackets for Preventing Enamel Demineralization

NCT07707336 | Completed

• 1 other identifier: D-F-H-24-11-18-b
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Enamel Surface Morphological Characteristics Adjacent to Orthodontic Brackets

  One month after bracket placement

Study Arms (2)

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.

Device: Silver Nanoparticle-Coated Stainless Steel Orthodontic Brackets

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.

Device: Conventional Stainless Steel Orthodontic Brackets

Interventions

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.

Silver Nanoparticle-Coated Brackets on Randomized Side

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.

Conventional Brackets on Randomized Side

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-extraction cases
• Patients with previously done orthodontic treatment
• Enamel surface defects on the premolars to be extracted(caries, hypoplasia, cracks etc.)

Sponsors & Collaborators

• Ajman University: lead

Study Sites (1)

Ajman University

Ajman, United Arab Emirates

Location

Study Officials

• Jeny M George, MDS

  Ajman University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 16, 2026
• Study Start: September 20, 2024
• Primary Completion: April 29, 2025
• Study Completion: May 23, 2025
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)