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临床试验/CTRI/2025/07/090569
CTRI/2025/07/090569尚未招募不适用

COMPARATIVE EVALUATION OF MECHANICAL PROPERTIES OF THERMOFORMED AND DIRECTLY PRINTED ALIGNER MATERIALS: AN IN VIVO STUDY

Divya Lohia1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年7月28日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
16
试验地点
1
主要终点
mechanical properties of aligners

研究概览

简要总结

This in vivo study aims to evaluate and compare the mechanical properties of two orthodontic aligner materials thermoformed and directly printed. With increasing demand for aesthetic orthodontic options clear aligners have become widely used. However conventional thermoformed aligners often show limitations such as low strength and dimensional instability. Directly printed aligners using advanced biocompatible materials like TC85DAC offer a potential improvement in these properties. The study involves sixteen patients divided into two groups each receiving one type of aligner. Mechanical properties such as tensile strength flexural strength and surface hardness are assessed at the beginning of treatment and after 14 days of intraoral use. Data is analyzed statistically to determine significant differences. The study has received ethical clearance and informed consent is obtained from all participants. Results are awaited and the findings are expected to guide material selection for improved clinical outcomes in aligner therapy.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • 1.Patient with good oral hygiene 2.Patient with mild to moderate malocclusion.
  • 3.Patient with good compliance to wear aligners 4.Patient should wear atleast 20-22 hours per day.

排除标准

  • 1.Patient with poor oral hygiene.
  • 2.Patient with a habit of smoking, tobacco chewing or bruxism.
  • 3.Any other food habit which could alter the aligner material properties.
  • 4.Distorted aligners.
  • •Patient with Esophageal reflux as it may affect the property of the material.

结局指标

主要结局

mechanical properties of aligners

时间窗: 4 weeks

次要结局

  • to determine which material is best for aligner fabrication(8 weeks)

研究者

发起方
Divya Lohia
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Divya Lohia

Sudha Rustagi College of Dental Sciences and Research

研究点 (1)

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