SleeperOne vs. Conventional Infiltration: Pain Perception in Mandibular Primary Molar Extraction

This randomized clinical trial aims to evaluate and compare the pain perception and anxiety levels associated with the use of a computer-controlled local anesthetic delivery system (SleeperOne®) versus conventional local infiltration using a standard syringe in pediatric patients undergoing extraction of mandibular primary molars.

A total of 28 healthy children aged 3 to 5 years, requiring extraction of at least one mandibular primary molar, will be enrolled and randomly assigned into two parallel groups: the intervention group (SleeperOne®) and the control group (conventional syringe). Both groups will receive the same anesthetic solution: 3% Mepivacaine without vasoconstrictor. Topical anesthesia will be applied using 20% benzocaine gel before injection in all participants.

Pain management during dental treatment in children is a major concern in pediatric dentistry. Traditional infiltration anesthesia using a syringe is effective but often associated with pain, anxiety, and fear, which can negatively affect child cooperation. Computer-controlled local anesthetic delivery (CCLAD) systems, such as the SleeperOne® 5, have been developed to minimize these issues by providing a slow and steady flow of anesthesia with improved ergonomics for the operator.

This randomized clinical trial will compare pain perception during maxillary primary molar extraction in children using the SleeperOne® 5 device versus conventional infiltration with a standard dental syringe. The trial will follow a parallel design with two arms: an intervention group receiving local anesthesia via the SleeperOne® 5, and a control group receiving conventional syringe infiltration.

Participants will be children aged 3-5 years who require extraction of a maxillary primary molar. Topical anesthesia with benzocaine will be applied prior to injection in both groups. Local infiltration will then be administered using either the SleeperOne® 5 or a conventional syringe, depending on group allocation.

The primary outcome is pain perception during injection and extraction, measured subjectively using the Wong-Baker Faces Pain Rating Scale (WBFPRS) and objectively using the Sound, Eye, and Motor (SEM) scale by an independent, blinded evaluator. Secondary outcomes include patient anxiety, recorded using the Modified Child Dental Anxiety Scale (MCDAS), and physiological responses (heart rate and blood pressure) measured with a digital monitor.

The study is designed with two parallel groups, with an anticipated sample size of 28 children (14 per group), based on a power calculation. Randomization will be performed using a computer-generated list. Blinding of participants is not possible due to the nature of the interventions, but outcome assessment will be blinded.

The results of this study are expected to provide clinical evidence on whether CCLAD (SleeperOne® 5) offers a significant advantage over conventional infiltration in reducing pain and anxiety during pediatric dental extractions.

• Patient anxiety [Срок оценки: During injection and extraction in the same clinical visit]
• Heart rate changes [Срок оценки: within 15 minutes after injection]
• Blood pressure changes [Срок оценки: within 15 minutes after injection]
• Soft tissue injury [Срок оценки: Within 24 hours after the procedure.]