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 range6 Years ā 12 Years
SexALL
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Inclusion criteria
ā. Children who were 6-12 years of age, of both sexes.
ā. Children who were healthy and medically fit; ASA I .
ā. 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.
ā. 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).
ā. Children with positive consent forms approved by their parents/ legal guardians.
Exclusion criteria
ā. Children who have had a history of unpleasant experiences in medical settings and/or LA injection procedures.
ā. Children with any mental, visual, or auditory impairment.
ā. Children who have medical or developmentally compromising conditions.
ā
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)
ā. Children with a history of chronic disease or use of medication that contraindicate the use of local anesthetics.
ā. Children who had active pathosis at the injection site that could affect anesthetic assessment.
ā. Patients who have negative (Class 2) or definitely negative (Class 1) behavior during preoperative behavioral assessments according to the Frankl Scale . - -