Clinical Trial Comparing Pain Perception in Children Using Two Different Local Anesthesia Tools (NCT07292194) | Clinical Trial Compass
CompletedNot Applicable
Clinical Trial Comparing Pain Perception in Children Using Two Different Local Anesthesia Tools
Jordan54 participantsStarted 2026-01-01
Plain-language 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.
Who can participate
Age range
6 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Self-reported pain using faces pain scale-revised (FPS-r)
Timeframe: Immediately post-procedural (within 1 minute after completion of the local anesthetic injection)
2
Observer-reported pain using Revised Face, Legs, Activity, Cry, Consolability Scale
Timeframe: Periprocedural (during local anesthetic injection, from needle insertion until completion of anesthetic delivery)
3
Physiological-Heart Rate
Timeframe: Baseline (5 minutes prior to local anesthetic injection) and periprocedural (during local anesthetic injection, from needle insertion until completion of anesthetic delivery)
. 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 . - -