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临床试验/NCT07431333
NCT07431333已完成不适用

Evaluation of The Efficiency of Directly Printed Shape Memory Vs Thermoformed Shape Memory Orthodontic Aligners

British University In Egypt1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2022年9月18日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
The efficiency of both directly printed and thermoformed aligners

研究概览

简要总结

Innovative recent materials are trying to achieve the most of orthodontic movements using the least number of aligner, also trying to reduce the manufacturing steps combined by enhancing the accuracy of each aligner.

详细描述

The aim of many recent interdisciplinary research studies is to introduce novel materials that can play an active role in the appliances. These materials are called smart materials or stimuli-responsive materials which have the ability to react suitably with external stimuli, such as thermal, electrical, or magnetic input, producing a predictable repeatable output. Shape memory materials are subcategory of smart materials which have the ability of changing their macroscopic shape upon a proper stimulus. Unlike shape changing materials, shape memory materials have the capacity to maintain a stable temporary shape until they are appropriately activated to recover their original shape.

Additive manufacturing, also known as 3D printing, dates back to the 1980s and is now reaching a level of maturity where it is now increasingly being used in the fields of both dental and medical modeling. There are multiple applications in oral surgery, prosthodontics, restorative dentistry, orthodontics, implantology and instrument manufacturing. Three-dimensional printing enables the manufacturing of pieces' layer-by-layer instead of common manufacturing methods that rely on machining, molding, and subtractive methods.

-Primary outcomes: Evaluation of the efficiency of both linear and angular tooth movement using directly printed shape memory orthodontic aligners Vs thermoformed shape memory orthodontic aligners (predicted Vs actual tooth movement).

-Secondary outcome: Evaluation of patient's compliance, comfort and color stability via written questionnaire.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Crowding in lower anterior teeth ranging from 4 to 6 mm.
  • Participants whose treatment plan need lower anterior teeth alignment.
  • Presence of permanent teeth except for lower premolar extraction performed for orthodontic purposes.
  • Participants who need orthodontic treatment after relapse in lower anterior teeth take place one-year post retention.

排除标准

  • Active systemic diseases that affect tooth movement (e.g. osteoporosis, bisphosphonate therapy, etc...).
  • Patients with biting habits (clinching, bruxism, etc…)
  • Patients with bad oral hygiene or high caries index or periodontal inflammation or gingival recession.
  • Presence of active labial caries or class V restorations or enamel hypoplasia in lower anterior teeth.

研究组 & 干预措施

Directly Printed Shape Memory Orthodontic Aligners used in lower anterior crowding treatment

Active Comparator

干预措施: shape memory clear aligners (Device)

Thermoformed Shape Memory Orthodontic Aligners used in lower anterior crowding treatment

Active Comparator

干预措施: shape memory clear aligners (Device)

结局指标

主要结局

The efficiency of both directly printed and thermoformed aligners

时间窗: from 6 to 8 months

the relief of mandibular anterior teeth crowding per duration of treatment measured in millimeters per total months

次要结局

  • compliance(from 6-8 months)
  • color stability(from 6 to 8 months)
  • aligners comfortability(from 6 to 8 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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