An interventional study of Direct In-House Clear Aligners and Indirect In-House Clear Aligners in Malocclusion, Angle Class I, sponsored by TC Erciyes University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 12 Years to 30 Years. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by TC Erciyes University · Not applicable, Interventional, and Treatment
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.
35 studies on the registry are indexed under Malocclusion, Angle Class I; 10 are open to participants now.
This study's enrollment of 36 is above the median of 32 across 31 interventional studies indexed under Malocclusion, Angle Class I.
Browse Malocclusion, Angle Class I studies →TC Erciyes University is the lead sponsor of 349 studies on the registry; 74 are open to participants now.
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Exclusion Criteria:
Participants received clear aligners manufactured directly by the clinician using 3D printing with a shape-memory resin (Tera Harz TC-85, Graphy Inc., Seoul, Korea).
Device: Direct In-House Clear Aligners
Participants received clear aligners manufactured indirectly by the clinician via 3D-printed models followed by thermoforming with CA Pro+ sheets (SCHEU-DENTAL GmbH, Iserlohn, Germany).
Device: Indirect In-House Clear Aligners
Participants received conventional fixed orthodontic treatment with metal brackets (AO Mini Master Roth 018).
Device: Fixed Orthodontic Appliances
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.
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.
Conventional fixed orthodontic treatment using metal brackets (AO, Mini Master Roth 018, ) bonded to the upper and lower dental arches with stainless steel archwires.
Treatment Quality Assessed by the American Board of Orthodontics Objective Grading System (ABO-OGS)
Post-treatment dental models were evaluated using the ABO Objective Grading System, which scores eight criteria: tooth alignment, marginal ridge height, buccolingual inclination, overjet, occlusal contacts, occlusal relationships, interproximal contacts, and root angulation. Lower total scores indicate better treatment quality. Scores were classified as successful (\<20), borderline (20-30), or unsuccessful (\>30).
Time frame: From the date of treatment initiation (attachment placement or bracket bonding) until the date of treatment completion (final day of aligner use or bracket debonding), assessed up to 13 months
Total Treatment Duration
The total duration of treatment was calculated as the time interval between treatment initiation (aligner delivery or bracket bonding) and treatment completion (final day of aligner use or bracket debonding)
Time frame: From the date of treatment initiation (attachment placement or bracket bonding) until the date of treatment completion (final day of aligner use or bracket debonding), assessed up to 13 months
Plan to share: No
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Ran from Feb 2024 to primary completion in Mar 2025, 13 months.
Of 23 interventional studies with no phase under Malocclusion, Angle Class I, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 24. This study's 13 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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