Direct vs Indirect In-House Clear Aligners vs Fixed Appliances in Orthodontic Treatment
NCT07687329 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2026-07-07
Summary
Clear aligner therapy has become increasingly popular as an esthetic alternative to conventional braces in orthodontic treatment. While clear aligners are traditionally manufactured by commercial laboratories using a thermoforming technique, recent advances in 3D printing technology now allow clinicians to produce aligners directly in their own clinic, either by printing the aligner itself (direct method) or by printing a model and then thermoforming the aligner over it (indirect method)." "This study compares three approaches to orthodontic treatment in patients with mild to moderate dental crowding who do not require tooth extraction: clear aligners produced directly in-house using 3D printing with a shape-memory resin, clear aligners produced indirectly in-house using a 3D-printed model and thermoforming, and conventional fixed orthodontic treatment with metal brackets and wires." "A total of 36 patients aged 12 to 30 years were randomly assigned to one of these three treatment groups, and 33 patients completed the study. Treatment quality was evaluated using the American Board of Orthodontics Objective Grading System (ABO-OGS), an objective scoring method based on dental models obtained at the end of treatment. The total duration of treatment, from the start of active treatment to its completion, was also compared among the three groups." "The findings of this study may help clinicians and patients better understand the advantages and limitations of in-house clear aligner production compared to conventional fixed appliances, particularly regarding treatment efficiency and duration.
Conditions
- Malocclusion, Angle Class I
Interventions
- DEVICE
-
Direct In-House Clear Aligners
Clear aligners fabricated directly by the clinician using a stereolithography (SLA) 3D printer (Asiga MAX UV) with a shape-memory resin (Tera Harz TC-85, Graphy Inc., Seoul, Korea). The shell of the aligner was designed digitally using Direct Aligner Designer software and printed directly, without the need for a physical model. Printed aligners were post-processed by centrifugation to remove excess resin, followed by UV light curing.
- DEVICE
-
Indirect In-House Clear Aligners
Clear aligners fabricated indirectly by the clinician via 3D-printed dental models (Asiga MAX UV printer) followed by thermoforming using CA Pro+ sheets (0.75 x 120 mm, SCHEU-DENTAL GmbH, Iserlohn, Germany) with a pressure-forming machine (MINISTAR S). The thermoformed aligners were trimmed from the printed model after shaping.
- DEVICE
-
Fixed Orthodontic Appliances
Conventional fixed orthodontic treatment using metal brackets (AO, Mini Master Roth 018, ) bonded to the upper and lower dental arches with stainless steel archwires.
Sponsors & Collaborators
-
The Scientific and Technological Research Council of Turkey
collaborator OTHER -
TC Erciyes University
lead OTHER
Principal Investigators
-
Ahmet Yağcı, Prof. Dr. · Erciyes University, Faculty of Dentistry, Department of Orthodontics
-
Musa Göksu, DDS · Erciyes University, Faculty of Dentistry, Department of Orthodontics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Max Age
- 30 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-15
- Primary Completion
- 2025-03-15
- Completion
- 2025-03-15
Countries
- Turkey (Türkiye)
Study Locations
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