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

NCT ID: NCT07124052

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-18
• Study Completion Date: 2026-09-18

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.

Detailed Description

This randomized controlled clinical trial is designed to evaluate and compare the pain perception in pediatric patients during maxillary primary molar extraction when local anesthesia is administered using either the SleeperOne® 5 electronic delivery system or the conventional infiltration technique with a standard syringe.

Participants will be healthy children aged 3 to 5 years, classified as ASA I or ASA II, requiring extraction of a maxillary primary molar. After obtaining informed consent from the parent or guardian, eligible participants will be randomly assigned to one of two groups using a sealed-envelope technique.

Both groups will receive topical anesthesia prior to local injection. In the control group, local anesthesia will be administered using a traditional 30-gauge dental needle and syringe. In the intervention group, anesthesia will be delivered using the SleeperOne® 5 device, which offers controlled flow and pressure to minimize discomfort.

Pain during injection and during extraction will be evaluated using both subjective and objective pain assessment tools: the Wong-Baker Faces Pain Rating Scale (WBFPR) and the Sound, Eye, Motor (SEM) scale. Secondary outcomes will include time of anesthetic onset and duration, as well as any post-operative complications such as soft tissue trauma or ulceration.

All procedures will be performed by the same pediatric dentist to ensure consistency, and the clinical environment will follow standard infection control protocols. This study aims to determine whether the use of a computer-assisted anesthesia system provides superior comfort and patient experience compared to conventional methods in young children undergoing dental extractions.

Conditions

Pain; Extraction, Tooth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Conventional Infiltration

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.

Group Type: EXPERIMENTAL

SleeperOne 5

Intervention Type: 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 Technique

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.

Group Type: ACTIVE_COMPARATOR

(Conventional Infiltration Anesthesia)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

(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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aya Hesham ElSayed Mohamed ElTanahy

OTHER

Sponsor Role: lead

Responsible Party

Aya Hesham ElSayed Mohamed ElTanahy

Master's Candidate in Pediatric Dentistry

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Aya Hesham ElTanahy, MSc

Role: CONTACT

aya.eltanahy@dentistry.cu.edu.eg

201112902348

Study Documents

Document Type: Informed Consent Form

Study protocol will be uploaded and publicly accessible upon final approval.

View Document

Related Links

https://www.dentalhitec.com/

it introduces the sleeper one 5 anesthetic device

Other Identifiers

8820255

Identifier Type: -

Identifier Source: org_study_id