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Bracketless Orthodontic Treatment (3D-BOT) Versus Conventional Fixed Braces for Mild-to-Moderate Lower Front Tooth Crowding in Adults
Sponsor: University of Aleppo
Summary
This study will compare two fixed orthodontic treatments for mild-to-moderate crowding of the lower front teeth in adults. Participants will be randomly assigned to three-dimensional bracketless orthodontic treatment (3D-BOT), which uses wires bonded directly to the teeth, or conventional braces attached to the front surfaces of the teeth. The main aim is to compare how tooth alignment changes during the first 24 weeks after appliance placement. Additional assessments will examine changes in tooth position and lower dental arch dimensions, oral and gum health, soft-tissue effects, quality of life and psychosocial well-being, patient experience and satisfaction, pain and painkiller use, appliance failures, time spent on clinical procedures and digital preparation, and changes in teeth and supporting bone. Data will be collected through clinical examinations, digital scans, questionnaires, home diaries and radiographic imaging.
Official title: Clinical and Digital Evaluation of the Effectiveness of Three-Dimensional Bracketless Orthodontic Treatment (3D-BOT) Using E-WIRE Archwires Versus Conventional Fixed Orthodontic Treatment: A Randomized Controlled Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 25 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-11-15
Completion Date
2028-12-15
Last Updated
2026-10-27
Healthy Volunteers
No
Interventions
Conventional Labial Fixed Orthodontic Appliance
Mini Master Series metal brackets (American Orthodontics), MBT prescription with 0.022-inch slots, will be bonded to teeth 45-35, with buccal tubes on 46 and 36. Nickel-titanium (NiTi) archwires will follow the planned sequence (inches): 0.012 at APP0; 0.014 after T1 (Week 4); 0.016 after T2 (Week 8); 0.016×0.022 after T3 (Week 12); 0.017×0.025 after T4 (Week 16); and 0.019×0.025 at Week 20. Progression requires clinically appropriate engagement without excessive force; otherwise, the current wire will be retained and reassessed. A 0.019×0.025-inch stainless steel wire will be placed after all T5 (Week 24) research assessments. IPR will follow the plan locked before randomization. No chains, springs or other auxiliaries directly affecting lower anterior alignment will be used during evaluation. Actual wire changes, delays, repairs and clinically necessary deviations will be documented.
3D-BOT Using E-WIRE Archwires
At APP0, a round coated E-WIRE (E-Wireligner; nominal size 0.014 inch) will be secured with GC Ortho Connect Flow (GC Orthodontics) from teeth 46 to 36 along a digitally planned posterior occlusal/anterior lingual path. After light curing, the water-soluble coating will be removed with a 60-second water wash. After the T2 (Week 8) digital scan, the initial wire and its composite will be removed, and a coated Velodrome E-WIRE (E-Wireligner; nominal size 0.016 × 0.022 inch) will be bonded to the lingual surfaces of teeth 43-33 only, using the same bonding and coating-removal procedures. IPR will follow the plan locked before randomization. No auxiliaries directly affecting lower anterior alignment will be used. Clinically necessary delays, repairs and deviations will be documented.
Locations (1)
Faculty of Dentistry, University of Aleppo
Aleppo, Aleppo Governorate, Syria