Comparative evaluation of Surface properties and Biofilm growth on 3D printed and thermoformed Clear aligners – An In Vivo prospective study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
研究概览
简要总结
Study Overview This split-mouth clinical study investigates surface properties and biofilm formation on two types of clear aligners 1. direct-printed and 2. Thermoformed aligners, used in mild malocclusion cases. Each patient receives both aligner types, randomly assigned to either arch, with a passive Zero aligner used initially for standardization.
Patient Protocol Participants wear aligners more than 20 hours/day for 14 days, clean them daily, except Day 14, and report compliance via a 3-point Likert scale.
Aligner Fabrication All aligners are fabricated by a certified orthodontist following industry and manufacturer protocols.
Sample Processing After 14 days, aligners are bisected:
One half is cleaned and analyzed for surface roughness with a profilometer and morphology using a SEM.
The other half is used for biofilm mass evaluation in saline solution.
Statistical Analysis Data will be analyzed using SPSS v21. Normality will be tested using Shapiro-Wilk/Kolmogorov-Smirnov tests.
If data is normal then ANOVA, t-tests, and Pearson’s correlation will be applied
If not, Kruskal-Wallis, Mann-Whitney, and Spearman’s correlation will be applied
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged between 18 years to 40 years with healthy permanent dentition, healthy periodontium, and excellent oral hygiene.
- •Patients that require mild correction of malocclusion within the scope of Clear aligner treatment.
排除标准
- •Patients with Craniomandibular disorders, and /or any systemic conditions Patients with Pathological conditions such as Bruxism and clenching Patients who smoke or consume tobacco Patients with poor oral hygiene or poor perceived compliance Patients who are pregnant or are breastfeeding Immunocompromised patients.
研究者
Dr Robin Mathew Neerumtharappel
Terna Dental College and Hospital