Direct 3D-printed vs thermoformed clear aligners in mild crowding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, parallel-arm randomized trial conducted at multiple centers comparing two clear aligner approaches for mild dental crowding or spacing in patients aged 16-30 with fully erupted permanent teeth. One group uses direct 3D-printed aligners made from Senertek Clear-A V2 resin, while the control group uses thermoformed aligners made from Zendura FLX on 3D-printed resin molds. Participants wear the aligners about 22 hours daily and change them every 7 days, with follow-up visits every 5 weeks. Outcomes include tracking accuracy between actual tooth movements and the digitally predicted plan, along with secondary measures of clinical efficiency, patient-reported pain, and manufacturing complexity. Digital models will be compared using STL superimposition anchored to stable structures like palatal rugae to assess precision of movement.

Why it matters

Who can join: the full rules

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.

Where it's running

• Specialized Dental Center for Prosthodontics and Orthodontics
  Baghdad, Bab Al-Muadham, Iraq Recruiting
• Z Orchida Clinic
  Baghdad, Iraq Recruiting
• Orthodontic department, College of dentistry, university of Baghdad.
  Baghdad, Iraq Recruiting

Study contacts

• Study coordinator: Ali Rahman Issa, PhD student
• Email: ali.hassan1902@codental.uobaghdad.edu.iq
• Phone: 009647801218939

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.