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Clinical Performance of Direct-Printed Versus Thermoformed Aligners

RecruitingNAAges 15 Years - 30 YearsAllUniversity of Baghdad
NCT07637227 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this study is to evaluate and compare the clinical effectiveness of in-office directly 3D-printed clear aligners versus conventional multilayered thermoformed aligners. The main question it aims to answer is: Does the use of in-office direct-printed shape-memory aligners result in superior clinical effectiveness, compared to established multilayer thermoformed aligner systems? Researchers will compare a Direct-Printed Aligner (DPA) group using Senertek Clear-A V2 resin to a Thermoformed Aligner (TFA) group using Zendura FLX multilayer sheets to see if the additive manufacturing process improves clinical outcomes and patient satisfaction. Participants will: * Undergo initial records including intraoral digital scans, photos, and a panoramic radiograph for treatment planning. * Wear their assigned clear aligners (either direct-printed or thermoformed) for at least 22 hours

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Adult patient with an age range of 15-30 with fully erupted all permanent dentitions excluding third molars, and a willingness to participate in the trial. 2. Angle Class I non-extraction cases, presented with mild crowding or spacing (\<5 mm) and dental rotation \<30° . 3. Good oral hygiene; no active caries/periodontal disease, no history of trauma or root resorption. Exclusion Criteria: 1. Pregnancy, smoking, and systemic conditions affecting bone remodeling. 2. Subject with poor oral hygiene, using simplified oral hygiene index (OHI-S ≥ 3.1 ) (Greene \& Vermillion, 1963). 3. Patient with malposed lower second molars (need orthodontic alignment). 4. Allergy to materials used (resins, plastics, solvents). 5. History of trauma, root resorption, and dilacerated roots. 6. Previous extraction or history of previous orthodontic treatment.
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What it tests

  • Direct-Printed Aligner
  • Thermoformed aligner
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Where

3 sites
Specialized Dental Center for Prosthodontics and Orthodontics
Baghdad, Iraq
Z Orchida Clinic
Baghdad, Iraq
Orthodontic department, College of dentistry, university of Baghdad.
Baghdad, Iraq
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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