Clinical Performance of Direct-Printed Versus Thermoformed Aligners
Recruiting now · Not applicable
Conditions studied: Angle Class I Malocclusion, Dental Crowding, Tooth Spacing
In brief
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 per day, changing them every 7 days. * Attend follow-up appointments every 5 weeks.
Key facts
- Study ID
- NCT07637227
- Run by
- University of Baghdad
- People needed
- 34
- Starts
- 2026-06-01
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2026-06-09
Who can join
Age: 15 and older, up to 30. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
- Angle Class I non-extraction cases, presented with mild crowding or spacing (<5 mm) and dental rotation <30° .
- Good oral hygiene; no active caries/periodontal disease, no history of trauma or root resorption.
You may not qualify if…
- Pregnancy, smoking, and systemic conditions affecting bone remodeling.
- Subject with poor oral hygiene, using simplified oral hygiene index (OHI-S ≥ 3.1 ) (Greene \& Vermillion, 1963).
- Patient with malposed lower second molars (need orthodontic alignment).
- Allergy to materials used (resins, plastics, solvents).
- History of trauma, root resorption, and dilacerated roots.
- Previous extraction or history of previous orthodontic treatment.
Where it is running
- Specialized Dental Center for Prosthodontics and Orthodontics — Baghdad, Bab Al-Muadham, Iraq (enrolling)
- Z Orchida Clinic — Baghdad, Iraq (enrolling)
- Orthodontic department, College of dentistry, university of Baghdad. — Baghdad, Iraq (enrolling)
Full record on ClinicalTrials.gov
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