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

NCT07156396 | Not Yet Recruiting

• 1 other identifier: 832025
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

This clinical trial is being conducted in the Department of Pediatric Dentistry, Faculty of Dentistry, Cairo University. The purpose of the study is to compare the pain perception and comfort of children during tooth extraction when using a computer-controlled local anesthetic device (SleeperOne® 5) versus the conventional syringe infiltration technique. Children between 3 and 5 years of age who require extraction of a maxillary primary molar will be invited to participate. Before starting, a topical anesthetic gel (benzocaine) will be applied. Then, local anesthesia will be given using either the SleeperOne® device or the traditional syringe, depending on the group assigned. Pain during injection and extraction will be assessed using both child-friendly rating scales and independent evaluation by the dentist. Patient anxiety, heart rate, and blood pressure will also be recorded. This study aims to provide evidence on whether computer-controlled anesthesia can reduce children's pain and anxiety compared with the conventional method, leading to a more comfortable dental experience. The study is a randomized clinical trial and will be conducted in a single visit at the Pediatric Dentistry Outpatient Clinic, Faculty of Dentistry, Cairo University. The results may help improve pain management and patient comfort during dental treatment for children.

Conditions

Dental Anxiety; Pain; Pain Management; Extraction, Tooth

Keywords

Pediatric dentistry; Tooth extraction; conventional infiltration; sleeperOne 5; Computer-Controlled anesthesia; Pain Perception

Outcome Measures

Primary Outcomes (1)

• Pain during injection

  Pain during injection will be assessed using the Sound-Eye-Motor (SEM) pain scale, which is a validated observational scale for evaluating pain response in pediatric patients. The SEM scale consists of three components-sound, eye, and motor reaction-each scored from 1 to 4, where a lower score indicates minimal or no pain and a higher score indicates greater discomfort. The total score is interpreted to reflect the child's behavioral reaction to the injection stimulus.

  immediately during local anesthetic injection

Secondary Outcomes (4)

• Patient anxiety

  During injection and extraction in the same clinical visit

• Heart rate changes

  within 15 minutes after injection

• Blood pressure changes

  within 15 minutes after injection

• Soft tissue injury

  Within 24 hours after the procedure.

Study Arms (2)

Conventional Infiltration

ACTIVE COMPARATOR

Children will receive 3% mepivacaine with conventional syringe after 20% benzocaine

Procedure: Conventional Infiltration

SleeperOne® Device

EXPERIMENTAL

Children will receive 3% mepivacaine using SleeperOne® device after 20% benzocaine.

Device: SleeperOne®, dental Hitec, France

Interventions

SleeperOne®, dental Hitec, France DEVICE

SleeperOne® is a computerized local anesthetic delivery system used to deliver 3% mepivacaine following application of 20% benzocaine topical gel. It is designed to reduce injection pain and improve comfort during pediatric dental procedures.

SleeperOne® Device

Conventional Infiltration PROCEDURE

Local anesthetic (3% mepivacaine) will be administered using a conventional dental syringe after the application of 20% benzocaine topical anesthetic.

Conventional Infiltration

Eligibility Criteria

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

You may qualify if:

• Children Aged between 3 to 5 years.
• Medically fit children classified as ASA physical status I and II
• Parents acceptance to participate in the study (informed consent)
• Children with teeth diagnostically confirmed to require extraction

You may not qualify if:

• Patients with an allergy to local anesthesia.
• Uncooperative children
• Children requiring general anesthesia

Sponsors & Collaborators

• Ameera Alaa Eldin Abdalazim Khalifa: lead

Related Links

• it introduces the sleeper one 5 anesthetic device

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Central Study Contacts

Ameera Alaa ElDin, MSc Candidate in Pediatric Den

CONTACT

01156165654; ameera.khalifa@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: MSc Candidate in Pediatric Dentistry, Faculty of Dentistry, Cairo University

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: September 5, 2025
• Study Start: September 2, 2025
• Primary Completion: September 2, 2025
• Study Completion: September 2, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share