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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Calcium-to-Phosphorus Ratio of Enamel Adjacent to Orthodontic Brackets
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Non-extraction cases
- •Patients with previously done orthodontic treatment
- •Enamel surface defects on the premolars to be extracted(caries, hypoplasia, cracks etc.)
结局指标
主要结局
Calcium-to-Phosphorus Ratio of Enamel Adjacent to Orthodontic Brackets
时间窗: 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.
次要结局
- Enamel Surface Morphological Characteristics Adjacent to Orthodontic Brackets(One month after bracket placement)