Enamel DemineralizationAgBracketNCT07707336
Silver Nanoparticle-Coated Orthodontic Brackets for Preventing Enamel Demineralization
A study testing Silver Nanoparticle-Coated Stainless Steel Orthodontic Brackets and Conventional Stainless Steel Orthodontic Brackets in people with Enamel Demineralization and White Spot Lesions, run by Ajman University at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Enamel Demineralization, White Spot Lesions
- What is being tested?
- Silver Nanoparticle-Coated Stainless Steel Orthodontic Brackets and Conventional Stainless Steel Orthodontic Brackets
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 20 Sep 2024to 23 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non-extraction cases
- Patients with previously done orthodontic treatment
- Enamel surface defects on the premolars to be extracted(caries, hypoplasia, cracks etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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:
Read more
-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.
Read the 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.
- Conditions
- Enamel Demineralization, White Spot Lesions
- Being tested
- Silver Nanoparticle-Coated Stainless Steel Orthodontic Brackets, Conventional Stainless Steel Orthodontic Brackets
- Keywords
- Enamel Demineralization, Silver Nanoparticles, Stainless Steel Brackets, Scanning Electron Microscopy, Energy-Dispersive X-ray Spectroscopy, White Spot Lesions, Orthodontics, Randomized Clinical Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver Nanoparticle-Coated Stainless Steel Orthodontic BracketsDevice
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 BracketsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Conventional Stainless Steel Orthodontic Brackets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One month after bracket placement
Secondary outcomes (1)
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.
Measured: One month after bracket placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start20 Sep 2024
- Primary completion29 Apr 2025
- Study completion23 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enamel DemineralizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajman University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeny M George, MDS, Principal investigator, Ajman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707336
- Sponsor's protocol ID
- D-F-H-24-11-18-b
- Acronym
- AgBracket
- Status last verified
- Jul 2026
- First submitted
- 28 Jun 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07707336
- Acronym / sponsor ID
- AgBracket / D-F-H-24-11-18-b
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ajman UniversityUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 29 Apr 2025 (actual)
- Study completion
- 23 May 2025 (actual)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Silver Nanoparticle-Coated Brackets on Randomized Side | Experimental | Device: 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 Side | Active comparator | Device: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Non-extraction cases
- Patients with previously done orthodontic treatment
- Enamel surface defects on the premolars to be extracted(caries, hypoplasia, cracks etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silver Nanoparticle-Coated Stainless Steel Orthodontic BracketsStainless 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. | Device | Silver Nanoparticle-Coated Brackets on Randomized Side |
| Conventional Stainless Steel Orthodontic BracketsConventional 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. | Device | Conventional Brackets on Randomized Side |
Primary outcome
Calcium-to-Phosphorus Ratio of Enamel Adjacent to Orthodontic Brackets
Time frame: 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.
1 secondary outcome
Enamel Surface Morphological Characteristics Adjacent to Orthodontic Brackets
Time frame: One month after bracket placement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeny M George, MDS principal investigator
Ajman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver Nanoparticle-Coated Stainless Steel Orthodontic Brackets and Conventional Stainless Steel Orthodontic Brackets in people with Enamel Demineralization and White Spot Lesions, run by Ajman University at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calcium-to-Phosphorus Ratio of Enamel Adjacent to Orthodontic Brackets (time frame: One month after bracket placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.