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临床试验/CTRI/2024/05/066706
CTRI/2024/05/066706尚未招募1 期

Comparative Evaluation of Mechanical Properties of 3 Different Aligner Materials: An in-vivo Study

Muskan Agarwal1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月10日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Mechanical Propeties of aligner

研究概览

简要总结

This is a prospective, randomised double blind study of three aligner materials PET, PETG and TPU on 5 patients of each material which includes students and patients visiting in the department of orthodontics from Sudha Rustagi College of Dental Sciences willing for orthodontic treatment. Samples of each material will be taken and thermoformed using thermoforming machine. Two sets of aligners need to be fabricated at the start of the study. One set is sent for study and one is delivered to the patient. Mechanical properties of each aligner, in terms of tensile strength, flexural strength, surface hardness will be obtained, using universal testing machine, and Vickers hardness tester before delivering the aligners to the patient. For each material we will carry out tests at interval of 7 days and 14 days after wear. At 7th day of aligner wear, the aligners will be collected from the patient, washed with distilled water and immediately sent for the tests. An additional aligner of the same series or another set of series will be delivered to the patient to replace the aligner collected for test purposes. Similar methodology will be used for 14th day.

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 goof oral hygiene 2.Patient with mild to moderate malocclusion 3.Patient with good compliance to wear aligners 4.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.
  • 5.Patient with Esophageal reflux as it may affect the property of the material.

结局指标

主要结局

Mechanical Propeties of aligner

时间窗: 4 Weeks

次要结局

未报告次要终点

研究者

发起方
Muskan Agarwal
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

Muskan

Sudha Rustagi College of Dental Sciences and Research Institute

研究点 (1)

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