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IRCT20260224068935N1 IRCT 2026-03-22 Kerman University of Medical Sciences Comparison of pain and anxiety during digital and conventional anesthesia in children Comparison of Pain and Anxiety Associated with Digital and Conventional Local Anesthesia Injection in Maxillary Primary Canine Teeth in Children Aged 5 to 9 Years 2026-04-21 anticipated 42 Complete https://irct.ir/trial/89311 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, participants are individually assigned to one of two treatment groups (A and B) using simple randomization with sealed envelopes; for this purpose, 42 cards (21 for treatment A and 21 for treatment B) were prepared, placed in sealed envelopes, and put into a box. Subsequently, the department secretary, unaware of the envelopes’ contents, randomly selects one envelope per participant without replacement, and the corresponding treatment is administered by a pediatric resident in the first visit (conventional for A, digital for B), with the second visit (digital for A, conventional for B) occurring 7 to 14 days later by the same resident; this process ensures allocation concealment, Blinding description: In this study, blinding has been implemented to prevent potential bias in participant responses. Participants will be unaware of which type of anesthesia intervention (digital or conventional) they are receiving during each visit. However, it should be noted that the resident responsible for administering the injections and assessing outcomes (pain and anxiety) is aware of the patients’ treatment group allocation. N/A Condition 1: Pain from Local Anesthetic Injections. Condition 2: Anxiety from Local Anesthetic Injections. Intervention 1: Intervention group: Digital anesthesia is first applied before the injection of local anesthetic using a benzocaine gel for 1-2 minutes on the previously dried mucosa. For digital anesthesia, the Sleeper One 5 device from Dental Hitec, French, and a short gauge 16 needle are used, following the manufacturer’s instructions. The anesthetic solution used is lidocaine with epinephrine 1:80,000. Intervention 2: Intervention group: first applied before the injection of local anesthetic using a benzocaine gel for 1-2 minutes on the previously dried mucosa.For conventional anesthesia, gauge 30 needles of 16mm length are used. The anesthetic solution used in both methods is lidocaine with epinephrine 1:80,000. Yes - There is a plan to make this available What will be shared: all collected deidentified IPD When: starting 12 months after publication To whom: The data will be available to all requesters, including researchers and administrators. Conditions: Data can be used solely for meta-analysis studies. Where to obtain: Applicants should email the corresponding author. How to obtain: Applicants should solely email the corresponding author, providing the title of their meta-analysis study and, if registered in PROSPERO, the PROSPERO code. Comments:
public Elham Faroukh-gisvar
Kerman - Islamic republic boulevard - the end of Shafa road - the faculty of dentistry of kerman university of medical sciences
kerman Iran (Islamic Republic of) 7616913555 +98 917 213 1306 Faroukh@kmu.ac.ir Kerman University of Medical Sciences scientific Elham Faroukh gisvar
Kerman - Islamic republic boulevard - the end of Shafa road - the faculty of dentistry of kerman university of medical sciences
kerman Iran (Islamic Republic of) 7616913555 +98 917 213 1306 Faroukh@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) children between 5 and 9 years who need to inject anesthesia in the maxillary canine teeth on both sides of the arch . they can communicate mentally . parental consent to the project patients with rating of frank's behavior 3 and 4 5 years 9 years Both Children who have used painkillers within 48 hours before treatment. Children with previous dental experience. Children with a history of significant behavioral management problems are excluded from the study. Have a systemic disease. Have contraindications for the use of local anesthetics. R52 F41.9 Pain, unspecified Anxiety disorder, unspecified Treatment - Other Treatment - Other Intervention group: Digital anesthesia is first applied before the injection of local anesthetic using a benzocaine gel for 1-2 minutes on the previously dried mucosa. For digital anesthesia, the Sleeper One 5 device from Dental Hitec, French, and a short gauge 16 needle are used, following the manufacturer’s instructions. The anesthetic solution used is lidocaine with epinephrine 1:80,000. Intervention group: first applied before the injection of local anesthetic using a benzocaine gel for 1-2 minutes on the previously dried mucosa.For conventional anesthesia, gauge 30 needles of 16mm length are used. The anesthetic solution used in both methods is lidocaine with epinephrine 1:80,000 Heart rate. Timepoint: during injection. Method of measurement: pulls oximeter. Pain. Timepoint: during injection. Method of measurement: according to Wong-baker scale. Physical reaction. Timepoint: during injection. Method of measurement: FLACC pain scale: Face (F): This refers to facial expressions. It includes observing muscle tension, frowning, or whether the eyes or mouth are open or closed. Legs (L): This category assesses the position and movement of the legs. It looks for whether the legs are relaxed, stiff, or if there are any involuntary movements like kicking or thrashing. Activity (A): This evaluates the child's overall activity level. It notes if they are calm, restless, or if their body is rigid. Cry (C): This focuses on the sound the person is making. It ranges from no crying to moaning or loud crying. Consolability (C): This measures how easily the person can be comforted. It assesses whether they can be soothed with touch or reassurance. Kerman University of Medical Sciences Approved 2025-11-02 Ethics committee of Kerman University of Medical Sciences Kerman - Islamic republic boulevard - the end of Shafa road - the faculty of dentistry of kerman university of medical sciences Kerman Kerman Iran (Islamic Republic of)