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COMPLETED
NCT07687329
NA

Direct vs Indirect In-House Clear Aligners vs Fixed Appliances in Orthodontic Treatment

Sponsor: TC Erciyes University

View on ClinicalTrials.gov

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.

Official title: Comparison Of Efficiency And Treatment Duration Between Clear Aligners Manufactured Directly And Indirectly By The Clinician And Fixed Orthodontic Treatment: An In Vivo Randomized Clinical Trial

Key Details

Gender

All

Age Range

12 Years - 30 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2024-02-15

Completion Date

2025-03-15

Last Updated

2026-07-07

Healthy Volunteers

No

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.

Locations (1)

Erciyes University, Faculty of Dentistry, Department of Orthodontics

Kayseri, Melikgazi, Turkey (Türkiye)