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

NCT07156396 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-09-05

No results posted yet for this study

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

Interventions

DEVICE

SleeperOne®, dental Hitec, France

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.

PROCEDURE

Conventional Infiltration

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

Sponsors & Collaborators

  • Ameera Alaa Eldin Abdalazim Khalifa

    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
2025-09-02
Primary Completion
2025-09-02
Completion
2025-09-02

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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 NCT07156396 on ClinicalTrials.gov