Comparison of Pain Perception in A Group of Pediatric Patients Undergoing Maxillary Primary Molar Extraction Using A Novel Anesthetic Device Versus Traditional Infiltration
Launched by AYA HESHAM ELSAYED MOHAMED ELTANAHY · Aug 8, 2025
Trial Information
Current as of September 06, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how much pain young children feel during the removal of a baby tooth in the upper jaw when given local anesthesia by two different methods. One method uses a new electronic device called SleeperOne® 5, which is designed to deliver the anesthesia more gently by controlling the flow and pressure, potentially making the injection less painful. The other method is the traditional way dentists usually give anesthesia with a syringe. The goal is to see if the new device can make the experience more comfortable for kids.
Children who are between 3 and 5 years old, are generally healthy, and need to have an upper baby molar removed may be eligible to join the study—with their parents’ permission. During the procedure, a numbing gel will be applied first, then the child will receive anesthesia either with the SleeperOne® 5 device or the traditional syringe, chosen at random. The researchers will carefully watch and measure how much pain the child feels during the injection and tooth removal, and also note how quickly the anesthesia works and how long it lasts. This study aims to help dentists find better ways to reduce pain and fear for young children during dental treatments.
Gender
ALL
Eligibility criteria
- * Inclusion criteria:
- • Children aged 3-5 years old
- • Medically fit children classified as ASA physical status I and II
- • Parents acceptance to participate in the study (informed consent)
- • Pediatric patients having teeth that have been diagnostically confirmed as requiring extraction.
- Exclusion criteria:
- • Uncooperative children.
- • Patients with an allergy to local anesthesia.
- • Children in need of treatment under general anesthesia.
About Aya Hesham Elsayed Mohamed Eltanahy
Aya Hesham Elsayed Mohamed Eltanahy is a clinical trial sponsor dedicated to advancing medical research through the coordination and support of clinical studies. Committed to upholding the highest standards of ethical conduct and scientific rigor, Aya facilitates the development and evaluation of innovative healthcare interventions to improve patient outcomes. Their work emphasizes collaboration with research institutions and adherence to regulatory requirements to ensure the reliability and integrity of clinical trial results.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported