Evaluation of Biological Reaction of Direct Three Dimensional Printed Retainers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Bacterial growth measured using colony-forming unit (CFU) count on agar plates.
研究概览
简要总结
The aim of this study will be to evaluate the biological reaction of direct three dimensional printed retainers.
Primary objective is to evaluate bacterial growth and color stability between different thicknesses of 3d printed material used as a retainer .
Secondary objective is to determine the optimal thickness for use in clear aligner fabrication based on biological performance.
详细描述
Retainers are routinely fitted at the end of active orthodontic treatment to allow the teeth to adjust to their new positions The growing demand has led to constant improvements in materials and technologies offered by a rising number of different companies.
In recent years, major technological innovations in 3D printing, especially related to computer-aided design, biomaterials and manufacturing techniques, have enabled the production of in-office direct printed Retainers (DPRs) - representing an innovation compared to the traditional thermoformed Retainers.
Insufficient cleaning will lead to microbe's growth in retainers. The mostly found microbes are candida and staphylococcus that may include MRSA strains. Once the biofilms are formed in the retainer it's quite difficult to remove that biofilm which shows resistance to antimicrobials and difficult to clear.
orthodontic retainers hinder the sterilizing effect of saliva, which further promotes the rapid division, reproduction, and growth of colonized bacteria.
Staphylococcus aureus is most commonly found on the retainers and tends to cause bloodstream infections which can lead to serious other infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •-Finished fixed orthodontic therapy and seeking for retention as a part of their original treatment plan.
- •Good oral hygiene.
- •No habits (e.g., smoking)
排除标准
- •Medication affecting saliva.
- •intrinsic tooth discoloration.
- •Uncooperative patients.
- •Patient with periodontitis.
- •Learning difficulties and inability to read written instructions.
结局指标
主要结局
Bacterial growth measured using colony-forming unit (CFU) count on agar plates.
时间窗: from day 0 (Baseline time ) to 14 days after insertion
Saliva samples will be collected from each participant at baseline and at day 14. Samples will be cultured on standard agar plates under aerobic conditions. After incubation, bacterial colonies will be counted, and results will be expressed in colony-forming units per milliliter (CFU/ml). A higher CFU value indicates greater bacterial growth. Units: CFU/ml
Color change of 3D printed retainers measured using spectrophotometer; ΔE calculated at day 0 and day 14.
时间窗: from day 0 (baseline time ) to 14 days after insertion
The color stability of the retainers will be assessed using a spectrophotometer (VITA Easyshade or equivalent). Color difference (ΔE) will be calculated between baseline and day 14. A ΔE \> 3.3 is considered clinically perceptible. Scale range: 0-10; higher ΔE score indicates greater color change and worse color stability. Units: ΔE (Delta E) score
Bacterial growth measured using colony-forming unit (CFU) count on agar plates.
时间窗: from day 0 (Baseline time ) to 14 days after insertion
Saliva samples will be collected from each participant at baseline and at day 14. Samples will be cultured on standard agar plates under aerobic conditions. After incubation, bacterial colonies will be counted, and results will be expressed in colony-forming units per milliliter (CFU/ml). A higher CFU value indicates greater bacterial growth. Units: CFU/ml
次要结局
未报告次要终点
研究者
Norhan Ibrahim Eldsokee Khidr
Principal Investigator, Master's Candidate at Orthodontic department at Al-Azhar University, Assiut branch.
Al-Azhar University