CTRI/2024/08/072423尚未招募3 期
Assessment of antimicrobial properties of gold nanoparticle coated thermoplastic orthodontic retainers and its influence on gingival health
Krishna Vishwa Vidyapeeth1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月24日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The study will evaluate gold nanoparticle-coated retainers for their effects on oral and gingival health and antimicrobial properties. We expect reductions in Porphyromonas gingivalis and Streptococcus mutans, improved gingival health, and positive feedback at 15 and 30 days. Comparative and statistical analyses will assess effectiveness and guide future research.
研究概览
简要总结
Aim of the study is to analyze the effect of gold nanoparticles coated retainers on oral and gingival health and to check its antimicrobial properties.
Objectives of study are-
- To evaluate the antimicrobial property of gold nanoparticle coated Thermoplastic orthodontic retainer on Porphyromonas. gingivalis and Streptococcus mutans strains.
- To evaluate the effect of gold nanoparticle coated Thermoplastic orthodontic retainer on oral and gingival health at the interval of 15 days from the retainer delivery.
- To evaluate the effect of gold nanoparticle coated Thermoplastic orthodontic retainers on oral and gingival health at the interval of 30 days from the retainer delivery.
- To compare and analyze the results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 16.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- Female
入选标准
- •The inclusion criteria for this study involve patients with permanent dentition who present with specific types of malocclusion.
- •Eligible participants must have Class 1 malocclusion with spacing and crowding within the range of 2-3 mm, as well as those with Class 2 Division 1 malocclusion.
- •This selection ensures a uniform group for evaluating the effects of gold nanoparticle-coated thermoplastic orthodontic retainers on oral and gingival health.
排除标准
- •Physically challenged patients.
- •Cleft lip and Palate.
- •Mentally challenged.
结局指标
主要结局
The study will evaluate gold nanoparticle-coated retainers for their effects on oral and gingival health and antimicrobial properties. We expect reductions in Porphyromonas gingivalis and Streptococcus mutans, improved gingival health, and positive feedback at 15 and 30 days. Comparative and statistical analyses will assess effectiveness and guide future research.
时间窗: The time points for this study are: | Baseline (at retainer delivery) | 15 days post-delivery | 30 days post-delivery
次要结局
- The secondary outcomes of the study will focus on patient experience and overall health, including comfort and satisfaction with the retainers, any changes in taste perception, and sensory feedback. Patient compliance and ease of use will be monitored, along with any adverse reactions such as allergies or irritation. The aesthetic appeal and its impact on patient confidence will be assessed. Additionally, the study will evaluate the longevity and durability of the gold nanoparticle-coated retainers. These outcomes will provide insights into the practicality, patient acceptance, and overall effectiveness of the retainers in real-world use.(The secondary outcomes of the study will be assessed at multiple time points to gauge patient experience and overall health. Evaluations will be conducted at baseline, 15 days, and 30 days after retainer delivery. These assessments will include patient comfort and satisfaction, changes in taste perception, sensory feedback, compliance, ease of use, any adverse reactions, aesthetic appeal, and the longevity and durability of the retainers.)
研究者
Dr Shreya Chinnawar
Krishna Vishwa Vidyapeeth
研究点 (1)
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