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

NCT07566533 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

  • Malocclusion
  • Orthodontic Treatment
  • Clear Aligner Therapy

Interventions

DEVICE

Single-Layer Thermoplastic Polyurethane Aligner

Single-layer thermoplastic polyurethane (TPU) clear aligners fabricated from a homogeneous TPU sheet using thermoforming techniques. These aligners are designed to deliver orthodontic forces for tooth movement. Participants will be instructed to wear the aligners intraorally for 10 days for a minimum of 22 hours per day. The aligners will be evaluated before use and after intraoral exposure to assess changes in mechanical properties and surface morphology.

DEVICE

Triple-Layer Thermoplastic Polyurethane Aligner

Triple-layer thermoplastic polyurethane (TPU) clear aligners composed of a multilayer structure including a soft inner layer, a rigid intermediate layer, and a flexible outer layer. These aligners are fabricated using thermoforming techniques and are designed to provide improved force delivery and adaptability. Participants will wear the aligners intraorally for 10 days for at least 22 hours per day. Pre- and post-use evaluations will be conducted to assess mechanical properties and surface morphology changes.

Sponsors & Collaborators

  • Ayub Medical College, Abbottabad

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-13
Primary Completion
2026-03-05
Completion
2026-03-16

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07566533 on ClinicalTrials.gov