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

NCT07124052 | Not Yet Recruiting

• 1 other identifier: 8820255
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Pediatric Dentistry; Pain Perception; SleeperOne 5; Computer-Controlled Anesthesia; Conventional Infiltration

Outcome Measures

Primary Outcomes (1)

• Pain perception during local anesthetic injection

  Pain will be assessed during the injection phase using the Wong-Baker Faces Pain Rating Scale (WBFPRS), a validated tool for pediatric pain assessment. Children will be asked to point to the face that best describes their pain level immediately after the injection is completed.

  during local anesthetic injection (within 1-2 minutes)

Secondary Outcomes (4)

• Effectiveness: Onset and recovery time of local anesthesia

  During and immediately after the procedure (Reference: Saoji et al., 2019)

• Duration of the procedure (injecting the anesthesia)

  During the procedure (Reference: Saoji et al., 2019)

• Incidence of postoperative ulcers

  24 hrs follow up

• Pain experienced during extraction

  During tooth extraction (Reference: Dhake et al., 2022)

Study Arms (2)

Conventional Infiltration

EXPERIMENTAL

Children in this group will receive local anesthesia using the SleeperOne® 5 electronic anesthesia delivery system (Dental Hi-Tec, France). The anesthetic solution used is 3% mepivacaine (Mepecaine-L®, Alexandria Co. for Pharmaceuticals and Chemical Industries, Egypt), administered via the device which controls flow and pressure to minimize discomfort during extraction of maxillary primary molars.

Device: SleeperOne 5

Conventional Infiltration Technique

ACTIVE COMPARATOR

Children in this group will receive local anesthesia using conventional infiltration via a standard dental syringe with a 30-gauge short needle. The anesthetic used is 3% mepivacaine (Mepecaine-L®, Alexandria Co. for Pharmaceuticals and Chemical Industries, Egypt). Buccal infiltration will be administered prior to extraction of maxillary primary molars.

Procedure: (Conventional Infiltration Anesthesia)

Interventions

SleeperOne 5 DEVICE

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.

Conventional Infiltration

(Conventional Infiltration Anesthesia) PROCEDURE

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.

Conventional Infiltration Technique

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Uncooperative children.
• Patients with an allergy to local anesthesia.
• Children in need of treatment under general anesthesia.

Sponsors & Collaborators

• Aya Hesham ElSayed Mohamed ElTanahy: lead

Related Links

• it introduces the sleeper one 5 anesthetic device

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Aya Hesham ElTanahy, MSc

CONTACT

201112902348; aya.eltanahy@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master's Candidate in Pediatric Dentistry

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 15, 2025
• Study Start: August 18, 2025
• Primary Completion: August 18, 2025
• Study Completion (Estimated): September 18, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share