NCT04863404.

Study name	Evaluation of the treatment effects of tooth‐borne versus bone‐anchored protraction procedures in Class III patients with maxillary deficiency
Methods	3‐arm parallel RCT
Participants	Number recruited: 42 participants Mean age: ages eligible for study: 10 to 13 years Inclusion criteria Late mixed or early permanent dentition C3 or C4 period according to the cervical vertebral maturation method Presence of skeletal class III malocclusion (ANB < 0°) Retrusive nasomaxillary complex (Nperp‐A < 1 mm) Presence of dental class III malocclusion Normal or horizontal growth pattern (SNGoGn < 40°) Negative overjet (overjet < 0) Good co‐operation Absence of any systemic disease Periodontal health No previous orthodontic treatment No craniofacial deformity No neuromuscular deformity Absence of a congenital anomaly Exclusion criteria Poor co‐operation Early mixed dentition Individuals who have passed the C4 period Craniofacial deformity Congenital anomaly History of facial trauma syndromes such as cleft lip and palate Setting: Izmir Katip Celebi University, Faculty of Dentistry, Department of Orthodontics, İzmir, Çiğli, Turkey
Interventions	Experimental: bone‐anchored maxillary protraction group, face mask with hybrid‐hyrax Experimental: tooth‐borne maxillary protraction group, face mask with conventional bonded RME No intervention: control group consisting of 14 people with non‐treated Class III malocclusion
Outcomes	Primary Pre‐treatment cephalometric analysis measures. A cephalometric analysis of skeletal maxillary (SNA) and mandibular (SNB) positions Pre‐treatment soft tissues measurements. Maxillary and mandibular (soft tissue convexity angle) soft tissue analysis using 3D stereophotogrammetry Secondary Post‐treatment cephalometric analysis measurements (time frame average of 6 months). Evaluation of post‐treatment cephalometric changes of skeletal maxillary (SNA) and mandibular (SNB) positions Post‐treatment soft tissues measurements (time frame average of 6 months). Evaluation of maxillary and mandibular soft tissue changes (soft tissue convexity angle) using 3D stereophotogrammetry
Starting date	15 June 2020
Contact information	Burcin Akan, Burcin.yksel@gmail.com
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