Efficacy of navigation system-assisted distraction osteogenesis for hemifacial microsomia based on artificial intelligence for 3 to 18 years old: study protocol for a randomized controlled single-blind trial.

"Declarations Ethics approval and consent to participate {24}This study was approved by the Independent Ethics Committee of Shanghai Ninth People’s Hospital Affiliated with Shanghai Jiao Tong University, School of Medicine (SH9H-2021-T461-2). Consent details will be obtained from participants and their parents or legal guardians. Consent for publication {32}Not applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. The participant information materials and informed consent form are available from the corresponding author on request. Competing interests {28}The authors declare that they have no competing interests. Competing interests {28} The authors declare that they have no competing interests."

"Funding {4} Clinical Research Plan of SHDC [No. SHDC2020CR3070B]; the project of Shanghai Municipal Key Clinical Specialty [No. shslczdzk00901] and the project of Clinical Research Program of 9th People’s Hospital affiliated to Shanghai Jiao Tong University School of Medicine [No. JYLJ202108]; Shanghai Jiao Tong University School of Medicine Two-hundred Talent [No. 20161420]."

"Trial registration Chinese Clinical Trial Registry ChiCTR2200061565. Registered on 29 June 2022."