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Comparison of Pain Perception in A Group of Pediatric Patients Undergoing Maxillary Primary Molar Extraction Using A Novel Anesthetic Device Versus Traditional Infiltration

NCT07124052 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-08-22

No results posted yet for this study

Summary

This study aims to compare the pain felt by children during tooth extraction using two different techniques for giving local anesthesia. One group of children will receive anesthesia using a modern electronic device called SleeperOne® 5, which controls the flow and pressure of the anesthesia to reduce pain. The other group will receive anesthesia using the traditional syringe method, which is more commonly used in dental clinics.

The study will include children between the ages of 3 and 5 years old who need to have an upper baby molar tooth extracted. All children in the study will be healthy (classified as ASA I or II), and their parents must agree to participate.

During the procedure, each child will first receive a topical anesthetic gel to numb the surface. Then, based on random selection, the child will receive local anesthesia using either the SleeperOne® 5 device or the traditional syringe. Pain levels during the injection and during the extraction will be measured using special scales suitable for children. Other factors like how long the anesthesia takes to work and how long it lasts will also be recorded.

This research will help dentists understand whether the SleeperOne® 5 device offers a more comfortable experience for young children compared to the traditional method. The goal is to reduce fear and pain during dental treatments for kids.

Conditions

  • Pain
  • Extraction, Tooth

Interventions

DEVICE

SleeperOne 5

A computerized local anesthetic delivery system (manufactured by Dental Hi-Tec, France) designed to minimize pain perception in children during dental procedures by controlling the pressure and flow rate of anesthetic injection. It will be used to deliver 3% mepivacaine (Mepecaine-L®, Alexandria Co. for Pharmaceuticals, Egypt) during maxillary primary molar extraction in pediatric patients.

PROCEDURE

(Conventional Infiltration Anesthesia)

Local anesthetic solution (3% mepivacaine with no vasoconstrictor), manufactured by Alexandria Co. for Pharmaceuticals, Egypt. It will be administered using a 30-gauge short dental needle and standard dental syringe for conventional infiltration anesthesia during primary maxillary molar extraction in pediatric patients.

Sponsors & Collaborators

  • Aya Hesham ElSayed Mohamed ElTanahy

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-18
Primary Completion
2025-08-18
Completion
2026-09-18

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07124052 on ClinicalTrials.gov