A prospective, multicenter, randomized, double-blind, placebo-controlled, superiority clinical trial to evaluate the efficacy and safety of a near-infrared vibrational orthodontic accelerator in accelerating orthodontic treatment

INTERVENTION: Experimental group:Test device;Control group:Control device; CONDITION: Dental and jaw facial deformities PRIMARY OUTCOME: The mean (mm) of cumulative distal movement distance of bilateral maxillary canines at Week 12 (V3) following canine retraction; SECONDARY OUTCOME: Satisfaction evaluation;Adverse Event;Root resorption;Tooth‐related reactions;Laboratory examinations;Pain severity assessment;Oral local reactions;Tooth movement rate;Periodontal health status; INCLUSION CRITERIA: 1.Inclusion Criteria 1: (1)Age 12 to 40 years (inclusive), both genders. (2)Diagnosed with maxillary protrusion and maxillary crowding Grade I (<4 mm) or Grade II (4–8 mm); orthodontic treatment plan includes extraction of bilateral maxillary first premolars. (3)Bilateral maxillary canines intact (no congenital absence, severe caries, periapical periodontitis, or periodontitis >= Grade II); no history of canine trauma; adolescent subjects: root development essentially complete with apical closure >=80% (confirmed by CBCT); adult subjects: complete root development. (4)Use of self‐ligating brackets, NiTi archwires, stainless steel archwires, NiTi closing springs, miniscrews and other auxiliary appliances for orthodontic treatment by the same manufacture. (5)Good compliance, able to complete daily intervention and scheduled follow‐up visits. (6)Subject or legal guardian signs informed consent form, understands the study purpose, complies with protoco