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Completed
NCT07687329
Direct vs Indirect In-House Clear Aligners vs Fixed Appliances in Orthodontic Treatment
Conditions: Malocclusion, Angle Class I
Sex: All
Ages: 12 Years – 30 Years
Healthy volunteers: No
Phase: NA
Enrollment: 36
Sponsor: TC Erciyes University
Location: Erciyes University, Faculty of Dentistry, Department of Orthodontics Kayseri Melikgazi
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.
Eligibility Criteria
Inclusion Criteria:
* Presence of permanent dentition (no primary teeth remaining)
* Non-extraction orthodontic treatment plan
* Age between 12 and 30 years
* Mild to moderate dental crowding (0-6 mm)
* Skeletal Class I classification (ANB: 2±2°)
* Normal vertical growth direction (Sn-GoGn: 32±6°)
* No congenital tooth agenesis (excluding third molars)
* No atypical tooth shapes
* No extracted permanent teeth
* No dental caries
* Good oral hygiene
* Healthy periodontal tissues
Exclusion Criteria:
* Presence of craniofacial anomalies
* Systemic disease or condition
* Previous fixed orthodontic treatment
* History of allergy to dental materials
* History of xerostomia
Source: ClinicalTrials.gov (NCT07687329). StuddyBuddy aggregates publicly available trial information.