Clinical Research Directory

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

Sponsor: Ameera Alaa Eldin Abdalazim Khalifa

Summary

This clinical trial is being conducted in the Department of Pediatric Dentistry, Faculty of Dentistry, Cairo University. The purpose of the study is to compare the pain perception and comfort of children during tooth extraction when using a computer-controlled local anesthetic device (SleeperOne® 5) versus the conventional syringe infiltration technique. Children between 3 and 5 years of age who require extraction of a maxillary primary molar will be invited to participate. Before starting, a topical anesthetic gel (benzocaine) will be applied. Then, local anesthesia will be given using either the SleeperOne® device or the traditional syringe, depending on the group assigned. Pain during injection and extraction will be assessed using both child-friendly rating scales and independent evaluation by the dentist. Patient anxiety, heart rate, and blood pressure will also be recorded. This study aims to provide evidence on whether computer-controlled anesthesia can reduce children's pain and anxiety compared with the conventional method, leading to a more comfortable dental experience. The study is a randomized clinical trial and will be conducted in a single visit at the Pediatric Dentistry Outpatient Clinic, Faculty of Dentistry, Cairo University. The results may help improve pain management and patient comfort during dental treatment for children.

Official title: Comparative Evaluation of A Novel Anesthetic Device vs. Conventional Infiltration in Pain Perception Among A Group of Pediatric Patients Undergoing Extraction Of Mandibular Primary Molars: A Randomized Clinical Trial

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