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IRCT20140601017935N10 IRCT 2026-06-16 Yazd University of Medical Sciences Comparison of pain in children using conventional syringe and digital syringe Comparison of Pain and Anxiety in Children Using Conventional Syringe and Computer-Controlled Local Anesthetic Delivery System during Inferior Alveolar Nerve Block 2026-05-22 anticipated 50 Complete https://irct.ir/trial/90101 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Randomization was performed using the blocked randomization allocation method. A random sequence was generated using PASS 2021 software based on block randomization. In total, twelve 4-member blocks were created to ensure the equal allocation of 50 participants into two groups (A: intervention, B: control). N/A Patient with reversible pulpitis in a mandibular primary molar. Intervention 1: Group A :An inferior alveolar nerve block injection will be administered using a digital syringe (Computer-Controlled Local Anesthetic Delivery System). Heart rate and oxygen saturation (SpO₂) will be recorded before and after the injection, and the child’s pain and anxiety levels will be assessed using standardized assessment tools. Intervention 2: Group B :An inferior alveolar nerve block injection will be administered using a conventional dental syringe. Heart rate and oxygen saturation (SpO₂) will be recorded before and after the injection, and the child’s pain and. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information is available.
public Zahra Sameii
Farhang 2 , Mehravaran
Yazd Iran (Islamic Republic of) 8915846793 +98 35 3625 6975 z.sameie1998@gmail.com Yazd University of Medical Sciences scientific Zahra Sameii
Farhang 2 , Mehravaran
Yazd Iran (Islamic Republic of) 8915846793 +98 35 3625 6975 z.sameie1998@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Healthy and (ASA I or II), aged 7 to 11 years, who require bilateral pulpotomy treatment in the mandibular primary molars. No allergy to local anesthetic agents No previous unpleasant dental experience Cooperative children (Frankl ratings 3 and 4) 7 years 11 years Both Withdrawal of the child or parents from participation in the study K04.0 Pulpitis Treatment - Devices Treatment - Devices Group A :An inferior alveolar nerve block injection will be administered using a digital syringe (Computer-Controlled Local Anesthetic Delivery System). Heart rate and oxygen saturation (SpO₂) will be recorded before and after the injection, and the child’s pain and anxiety levels will be assessed using standardized assessment tools. Group B :An inferior alveolar nerve block injection will be administered using a conventional dental syringe. Heart rate and oxygen saturation (SpO₂) will be recorded before and after the injection, and the child’s pain and The outcome variable of anesthesia success on the WB scale is considered a successful treatment with scores of zero and two and a failure with scores of four to ten. Similarly, FBRS grades three and four are considered a successful treatment and grades one and two are considered a failure. Timepoint: In the same treatment session. Method of measurement: To determine the level of pain during pulp treatment, we use two objective and subjective indicators. The Wong-Baker FACES Pain Rating Scale; WBS, which is a set of six facial images, is used to subjectively measure pain. Each child is asked to select a face from the WBS that represents their level of pain.The Face Leg Activity Cry Consolability (FLACC) scale is an objective pain measurement index that includes 5 sections: facial expression, leg position, child activity, crying, and child consolability. Each section is assigned a score between 0 and 2, and the total score is calculated. To measure the level of pain based on the FLACC index, it is performed by another assistant who is independent of the study and its results. Yazd University of Medical Sciences Approved 2026-01-12 Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd Imam Reza Boulevard Yazd Yazd Iran (Islamic Republic of)