Child Anxiety During Administration of Anesthesia Delivered by Dentapen® Technique Versus Traditional Syringes Among a Group of Pediatric Dental Patients: Randomized Clinical Trial

This is a single-center, prospective, parallel-group, randomized clinical trial with a 1:1 allocation ratio, designed to compare child anxiety associated with local anesthetic administration using a computer-controlled local anesthetic delivery (CCLAD) system (Dentapen®) versus a traditional aspirating syringe. The study will be conducted at the Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University, Egypt. The operator cannot be blinded due to the distinct appearance of the devices; however, participants (who will be supine with eyes closed during the procedure), the outcome assessor (who will evaluate recorded video footage cropped to obscure the injection site and the hand holding the device), and the statistician will be blinded.

Intervention Details:

Experimental (Dentapen®): The CCLAD device (Dentapen®, Septodont, Saint-Maur-des-Fossés, France) will be used in its ramp-up mode, which delivers a gradual, slow initial flow of anesthetic that increases to a constant flow over five seconds. This mode operates at the device's slowest speed (1 mL/90 s) at maximum force. Standard disposable 30-gauge, 20 mm needles and standard anesthetic cartridges (1.7 mL of 4% articaine with 1:100,000 epinephrine, Artpharmadent, Egypt) will be used. The technique will consist of a buccal infiltration followed by an intrapapillary infiltration.

Comparator (Traditional Syringe): A side-loading stainless steel aspirating syringe (Medesy® 4957/1, Italy) will be used with an identical anesthetic cartridge and needle (30-gauge, 20 mm). The same infiltration technique (buccal, then intrapapillary) will be performed, with manual control of injection speed and pressure.

Standardized Clinical Procedure: For all participants, the injection site will be dried and topical anesthetic (20% benzocaine gel, Iolite gel, Dharma Research Inc., USA) will be applied for one minute. Anesthetic will be deposited for the buccal infiltration at the depth of the buccal vestibule over the apices of the target upper primary first molar, with the needle bevel oriented toward the bone and aspiration performed prior to deposition. Intrapapillary infiltration will be performed one minute later, with the needle inserted 1-2 mm into the mesial and distal interdental papillae. The total volume of anesthetic and the rate of deposition will be recorded for each participant. Anesthetic efficacy will be confirmed using both subjective (patient report) and objective (dental probe) methods 3-5 minutes post-injection, prior to the dental extraction.