Clinical Trial

Comparison of Single-Layer and Triple-Layer TPU MaxFlex Aligners After Intraoral Use

Study acronym: TPU-ALIGN
Completed
View on ClinicalTrials.gov →
Summary
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.
Trial Details
NCT Number NCT07566533
Lead Sponsor Ayub Medical College, Abbottabad
Conditions Malocclusion, Orthodontic Treatment, Clear Aligner Therapy
Enrollment 66 participants
Start Date 2025-09-13
Primary Completion 2026-03-05 (estimated)
Study Completion 2026-03-16 (estimated)
Updated on ClinicalTrials.gov 2026-05-05