Effects of Intraoral Aging on Mechanical Properties and Surface Morphology of Single-Layer Versus Triple-Layer Thermoplastic Polyurethane (TPU) MaxFlex Aligner Sheets: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
研究概览
简要总结
This study aims to compare two types of clear orthodontic aligner materials used in dental treatment: single-layer and triple-layer thermoplastic polyurethane (TPU) aligners (MaxFlex). Clear aligners are commonly used to straighten teeth and are preferred for their comfort and aesthetic appearance.
Participants will be provided with aligners and instructed to wear them for approximately 22 hours per day for 10 days. The aligners will be collected before use and after the 10-day period. The study will evaluate how the oral environment affects the properties of these materials over time.
Laboratory tests will be conducted to measure mechanical properties such as strength, flexibility, and deformation, as well as to examine surface changes under a microscope. The results of this study may help improve the performance and durability of aligners and contribute to better orthodontic treatment outcomes.
详细描述
Clear aligner therapy (CAT) has become an increasingly popular alternative to fixed orthodontic appliances due to its aesthetic advantages, improved patient comfort, and ease of oral hygiene maintenance. Thermoplastic materials, particularly thermoplastic polyurethane (TPU), are widely used in the fabrication of aligners due to their favorable mechanical and elastic properties.
Recent advancements in aligner materials have led to the development of multilayer TPU systems designed to enhance flexibility, force delivery, and clinical performance. Triple-layer TPU aligners typically consist of a soft inner layer for patient comfort, a rigid intermediate layer for structural strength, and a flexible outer layer to improve adaptability and fit. In contrast, single-layer TPU aligners are composed of a homogeneous material and are generally more cost-effective.
Despite these developments, limited evidence exists regarding the comparative behavior of single-layer and multilayer TPU materials following intraoral exposure. The oral environment, characterized by temperature fluctuations, moisture, masticatory forces, and enzymatic activity, may contribute to material degradation, potentially affecting aligner performance.
This randomized controlled trial is designed to evaluate the effects of intraoral aging on the mechanical properties and surface morphology of single-layer and triple-layer TPU aligners (MaxFlex). Participants will be randomly assigned to receive one type of aligner material and will be instructed to wear the aligners for a standardized duration of 10 days (minimum 22 hours per day).
Aligners will be collected at baseline (prior to intraoral use) and after the 10-day wear period. Following retrieval, samples will undergo standardized cleaning procedures before laboratory analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The investigators performing laboratory analyses, including mechanical testing and surface morphology evaluation, will be blinded to group allocation to minimize assessment bias.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-30 years Fully erupted permanent dentition Good periodontal health Patients undergoing orthodontic treatment with clear aligners Mild crowding or spacing requiring labiolingual tooth movement Willingness to wear aligners for at least 22 hours per day Provision of informed consent
排除标准
- •Use of aligners from manufacturers other than study-specific TPU aligners Damaged or fractured aligners Poor compliance (wear time less than 22 hours/day) Presence of parafunctional habits (e.g., bruxism) Hypodontia or partially erupted dentition Cases involving bonded attachments on maxillary incisors Cases requiring rotational movement of maxillary incisors Patients with systemic or oral conditions affecting saliva composition or the oral environment
研究者
Abdul Qadir
Doctor
Akhtar Saeed Medical and Dental College