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Search / Trial NCT07156396

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

Launched by AMEERA ALAA ELDIN ABDALAZIM KHALIFA ·

Trial Information

Current as of September 25, 2025

Not yet recruiting

Keywords

Pediatric Dentistry Tooth Extraction Conventional Infiltration Sleeper One 5 Computer Controlled Anesthesia Pain Perception

ClinConnect Summary

This study, planned at Cairo University’s Department of Pediatric Dentistry, is testing whether a computer-controlled local anesthesia device (SleeperOne®) is more comfortable for kids than the usual syringe method during tooth extraction. About 28 healthy children aged 3 to 5 years who need a primary molar pulled will be invited to participate. To be eligible, children should be medically fit for minor dental work (no serious health problems), have a parent or guardian who consents, and be able to cooperate during the visit. Exclusion criteria include allergy to local anesthesia, inability to stay still, or needing general anesthesia.

Children will be randomly assigned to either the SleeperOne device or the conventional syringe, after applying a topical numbing gel. The study will look mainly at pain during the injection, using a simple behavior-based scale, and also track anxiety, heart rate, blood pressure, and any soft tissue injury within 24 hours. Outcome assessors are kept blind to group assignment to reduce bias. The trial is not recruiting yet and results are not available, but it aims to determine if computer-controlled anesthesia can reduce pain and anxiety compared with the traditional method.

Gender

ALL

Eligibility criteria

About Ameera Alaa Eldin Abdalazim Khalifa

Ameera Alaa Eldin Abdalazim Khalifa is a clinical trial sponsor committed to advancing high-quality, ethical medical research. She provides strategic oversight of study design and implementation, ensuring regulatory compliance, robust data integrity, and rigorous safety monitoring throughout the trial lifecycle. Ms. Khalifa prioritizes participant welfare and informed consent, fosters collaborative relationships with investigators and clinical sites, and supports transparent reporting of results. Her approach emphasizes adherence to good clinical practice, timely regulatory submissions, and continuous quality assurance to deliver reliable, patient-centered research outcomes.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported