Clinical Performance of Direct-Printed Versus Thermoformed Aligners
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-30
SponsorUniversity of Baghdad
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Direct-Printed Aligner
- Thermoformed aligner
Treatment groups
34 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov