Efficacy and safety of articaine in 3-year-old children for dental procedures: a protocol for a clinical randomised control trial in Saudi Arabia

INTRODUCTION: Despite the wide use of articaine in paediatric dentistry owing to its proven effectiveness and safety, articaine application in children <4 years remains controversial due to a lack of data on the use of articaine in very young children. This trial aims to examine the efficacy and safety of 4% articaine compared with 2% mepivacaine in children 3–4 years old requiring dental extractions. We aim to assess local anaesthetic efficacy and safety through a local anaesthetic infiltration technique for primary teeth requiring dental extraction in children 3 years old. METHODS AND ANALYSIS: This prospective, double-blind, randomised clinical trial with two parallel arms aims to evaluate the safety and efficacy of 4% articaine compared with 2% mepivacaine in 3-year-old children. The trial’s outcomes will be assessed by measuring the pain experienced during injection and treatment, evaluating the child’s behaviour during the procedure, and monitoring postoperative pain and complications. A total of 200 children will be included in the study, with 100 children in each arm. ETHICS AND DISSEMINATION: The Institutional Review Board (IRB) approved the study protocol and informed consent documents before initiation of the study. The IRB approval was granted by the Qassim Health Cluster under protocol number 607/43/7809. This study was also approved by the Saudi Food and Drug Authority. The study report will be disseminated through scientific forums, including peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: Saudi Clinical Trial Registry (22071802) and ClinicalTrials.gov Registry (NCT05839548).