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IRCT20260419069108N1 IRCT 2026-05-13 Qazvin University of Medical Sciences clinical trial comparing pain, anxiety and disruptive behavior during inferior alveolar nerve block Randomized split-mouth clinical trial comparing pain, anxiety and disruptive behavior during inferior alveolar nerve block using traditional syringe and digital. 2026-07-03 anticipated 30 Complete https://irct.ir/trial/89783 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization using sealed, opaque envelopes containing an equal number of intervention (digital method) and control (traditional method) allocations will be employed. The envelopes will be provided to a ward nurse who is not involved in any subsequent part of the study. Each time, the nurse will draw one envelope to determine whether the patient will receive the intervention or control, Blinding description: he injection technique for the block will be performed in such a way that the child (participant) cannot see the type of syringe used. Furthermore, the group allocation results for each subject will be provided to the statistical analyst in the form of numerical codes. N/A injection in pediatric dentistry. Intervention 1: Intervention group: Here is the scientific English translation of the "Intervention Group" text you provided, without additional explanations:**Intervention group:** Informed consent will first be obtained from the patient. A complete medical and dental history will be taken in writing from the parents. Subsequently, a full patient examination, including clinical and radiographic evaluation, will be performed. The clinical examination will be conducted first, and a diagnosis of dental caries in tooth D or E will be made. To confirm the diagnosis and the need for pulp therapy, a periapical radiograph will be taken. The treatment plan—either pulpotomy or pulpectomy—and the need for bilateral mandibular nerve block will be established. It should be noted that in each child, the tooth type (D or E) and the treatment plan (pulpotomy or pulpectomy) will be exactly the same on both sides of the mouth.1) The tell-show-do technique will first be performed for the patient.2) A cotton roll will be placed on the anesthesia injection site for 60 seconds to completely dry the area.3) Proccaine gel will be applied to the anesthesia site for 2 minutes.4) An appropriate needle (27-gauge, 25 mm length) will then be selected.5) The needle will be inserted into the tissue using the Dentapen device. After passing through the mucosa and contacting the bone, 1.5 to 1.8 mL of local anesthetic solution—lidocaine 2% with epinephrine 1:80,000—will be injected. Intervention 2: Control group: Here is the scientific English translation of your text, as requested without explanations:"Informed consent will first be obtained from the patient. A complete medical and dental history will be taken in writing from the parents. Subsequently, a full patient examination, including clinical and radiographic evaluation, will be performed. The clinical examination will be conducted first, and a diagnosis of dental caries in tooth D or E will be made. To confirm the diagnosis and the need for pulp therapy, a periapical radiograph will be taken. The treatment plan—either pulpotomy or pulpectomy—and the need for bilateral mandibular nerve block will be established. It should be noted that in each child, the tooth type (D or E) and the treatment plan (pulpotomy or pulpectomy) will be exactly the same on both sides of the mouth.1) The tell-show-do technique will first be performed for the patient.2) A cotton roll will be placed on the anesthesia injection site for 60 seconds to completely dry the area.3) Proccaine gel will be applied to the anesthesia site for 2 minutes.4) An appropriate needle (27-gauge, 25 mm length) will then be selected.5) The needle will be inserted into the tissue using a traditional syringe. After passing through the mucosa and contacting the bone, 1.5 to 1.8 mL of local anesthetic solution—lidocaine 2% with epinephrine 1:80,000—will be injected.". 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 There is no further information.
public Razie Sadat Hosseininavaz
Bahonar Blvd
Qazvin Iran (Islamic Republic of) 13911/34156 +98 28 7777 3333 rshn1016@gmail.com Qazvin University of Medical Sciences scientific Razie sadat Hosseininavaz
Bahonar Blvd
Qazvin Iran (Islamic Republic of) 3471976160 +98 28 3335 3062 rshn1016@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) children aged 5 to 8 years, provided that their developmental stage is consistent with their chronological age children classified as American Society of Anesthesiologists (ASA) physical status I children requiring bilateral mandibular nerve blocks children with no prior history of receiving dental local anesthesia before the study 5 years 8 years Both patients with a history of hypersensitivity to local anesthetics patients with any mental or physical condition that might interfere with the treatment procedure. G89.1 Acute pain, not elsewhere classified Treatment - Other Treatment - Other Intervention group: Here is the scientific English translation of the "Intervention Group" text you provided, without additional explanations:**Intervention group:** Informed consent will first be obtained from the patient. A complete medical and dental history will be taken in writing from the parents. Subsequently, a full patient examination, including clinical and radiographic evaluation, will be performed. The clinical examination will be conducted first, and a diagnosis of dental caries in tooth D or E will be made. To confirm the diagnosis and the need for pulp therapy, a periapical radiograph will be taken. The treatment plan—either pulpotomy or pulpectomy—and the need for bilateral mandibular nerve block will be established. It should be noted that in each child, the tooth type (D or E) and the treatment plan (pulpotomy or pulpectomy) will be exactly the same on both sides of the mouth.1) The tell-show-do technique will first be performed for the patient.2) A cotton roll will be placed on the anesthesia injection site for 60 seconds to completely dry the area.3) Proccaine gel will be applied to the anesthesia site for 2 minutes.4) An appropriate needle (27-gauge, 25 mm length) will then be selected.5) The needle will be inserted into the tissue using the Dentapen device. After passing through the mucosa and contacting the bone, 1.5 to 1.8 mL of local anesthetic solution—lidocaine 2% with epinephrine 1:80,000—will be injected. Control group: Here is the scientific English translation of your text, as requested without explanations:"Informed consent will first be obtained from the patient. A complete medical and dental history will be taken in writing from the parents. Subsequently, a full patient examination, including clinical and radiographic evaluation, will be performed. The clinical examination will be conducted first, and a diagnosis of dental caries in tooth D or E will be made. To confirm the diagnosis and the need for pulp therapy, a periapical radiograph will be taken. The treatment plan—either pulpotomy or pulpectomy—and the need for bilateral mandibular nerve block will be established. It should be noted that in each child, the tooth type (D or E) and the treatment plan (pulpotomy or pulpectomy) will be exactly the same on both sides of the mouth.1) The tell-show-do technique will first be performed for the patient.2) A cotton roll will be placed on the anesthesia injection site for 60 seconds to completely dry the area.3) Proccaine gel will be applied to the anesthesia site for 2 minutes.4) An appropriate needle (27-gauge, 25 mm length) will then be selected.5) The needle will be inserted into the tissue using a traditional syringe. After passing through the mucosa and contacting the bone, 1.5 to 1.8 mL of local anesthetic solution—lidocaine 2% with epinephrine 1:80,000—will be injected." Objective assessment of pain. Timepoint: during inferior alveolar nerve block injection. Method of measurement: Face, Legs, Activity, Cry, Consolability (FLACC) scale. Subjective assessment of pain. Timepoint: after inferior block injection. Method of measurement: Wong-baker scale. Pulse. Timepoint: before and during inferior alveolar black. Method of measurement: pulse oximeter. Oxygen saturation of blood. Timepoint: before and during inferior alveolar black. Method of measurement: pulse oximeter. Anxiety. Timepoint: after inferior alveolar black injection. Method of measurement: Venham anxiety index. Qazvin university of Medical Sciences Approved 2026-02-23 Ethics Committee of Qazvin University of Medical Sciences Bahonar Blvd. Qazvin Qazvin Iran (Islamic Republic of)