Clinical Trial Comparing Pain Perception in Children Using Two Different Local Anesthesia Tools

NCT07292194 | Completed DMC

• 1 other identifier: UJordanLamis2
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical study is to learn whether the Super Pen (SP) device can reduce pain during local anesthesia (LA) infiltration for primary teeth compared to the conventional syringe (CS) in children aged 6-12 years. It will also explore factors that influence children's pain perception and their preferences for the anesthesia delivery method. The main questions this study aims to answer are:

• Does the Super Pen (SP) reduce the pain experienced during LA infiltration compared to the conventional syringe (CS)?
• How do factors such as age, sex, and arch treated (maxilla or mandible) influence children's pain perception when using the SP?
• Which method-SP or CS-do children prefer during LA infiltration? Participants will: Receive local anesthesia using both the SP and CS techniques in a split-mouth design. Have their pain responses assessed using self-reported, behavioral, and physiological measures. Indicate their preference for either technique after both experiences.

Conditions

Injection Pain; Local Anesthesia Infiltration; Pediatric Patient

Keywords

clinical trial; split mouth; dental pain; local anesthesia device; local anesthesia infiltration

Outcome Measures

Primary Outcomes (3)

• Self-reported pain using faces pain scale-revised (FPS-r)

  Pain intensity measured using the Faces Pain Scale - Revised (FPS-R), ranging from 0 to 10, where higher scores indicate greater pain.

  Immediately post-procedural (within 1 minute after completion of the local anesthetic injection)

• Observer-reported pain using Revised Face, Legs, Activity, Cry, Consolability Scale

  Pain behavior measured using the Face, Legs, Activity, Cry, Consolability - Revised (FLACC-R) Scale, scored from 0 to 10, where higher scores indicate greater pain-related distress.

  Periprocedural (during local anesthetic injection, from needle insertion until completion of anesthetic delivery)

• Physiological-Heart Rate

  Changes in heart rate measured in beats per minute (bpm); increases in heart rate indicate higher physiological arousal associated with pain

  Baseline (5 minutes prior to local anesthetic injection) and periprocedural (during local anesthetic injection, from needle insertion until completion of anesthetic delivery)

Study Arms (2)

Super Pen

ACTIVE COMPARATOR

Super Pen Computer-controlled Local Anesthesia delivery system

Device: super pen

Conventional Syringe

NO INTERVENTION

Conventional metal syringe

Interventions

super pen DEVICE

computer controlled local anesthesia delivery device

Super Pen

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children who were 6-12 years of age, of both sexes.
• Children who were healthy and medically fit; ASA I .
• Children who had positive (Class 3) or definitely positive (Class 4) behavior during preoperative behavioral assessments according to the Frankl Scale at the enrollment visit.
• Children who require bilateral LA infiltration injections for primary teeth, either in the maxilla or mandible, for dental treatment (different types of restoration, stainless steel crowns, pulp therapy, and extractions).
• Children with positive consent forms approved by their parents/ legal guardians.

You may not qualify if:

• Children who have had a history of unpleasant experiences in medical settings and/or LA injection procedures.
• Children with any mental, visual, or auditory impairment.
• Children who have medical or developmentally compromising conditions.
• Children who had developmental delay problems.
• Children with a history of chronic disease or use of medication that contraindicate the use of local anesthetics.
• Children who had active pathosis at the injection site that could affect anesthetic assessment.
• Patients who have negative (Class 2) or definitely negative (Class 1) behavior during preoperative behavioral assessments according to the Frankl Scale . - -

Sponsors & Collaborators

• Lamis D. Rajab: lead

Study Sites (1)

Lamis

Amman, Jordan

Location

MeSH Terms

Conditions

Toothache

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 18, 2025
• Study Start: January 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

JO (1)