Clinical Trial

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

Study acronym: SOTIMAN
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07156396
Lead Sponsor Ameera Alaa Eldin Abdalazim Khalifa
Conditions Dental Anxiety, Pain, Pain Management, Extraction, Tooth
Enrollment 28 participants
Start Date 2025-09-02
Primary Completion 2025-09-02 (estimated)
Study Completion 2025-09-02 (estimated)
Updated on ClinicalTrials.gov 2025-09-05