Ethics approval and consent to participate
18/6/2021
This study was conducted in accordance with the Declaration of Helsinki on medical protocol and ethics and all national ethical standards. Ethical approval was obtained from the Research Ethics Committee, Faculty of Dentistry, Alexandria University (#0086–11/2019). Signed informed consent was obtained from all patients and/ or their guardians before participating in the study. For participants aged 10 to 18 years, informed consent was obtained from parents or guardians. The trial was prospectively registered on the clinicaltrials.gov registry (NCT04929509) on 18/6/2021.