Clinical Trial Comparing Pain Perception in Children Using Two Different Local Anesthesia Tools
NCT ID: NCT07292194
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
54 participants
INTERVENTIONAL
2026-01-01
2026-04-01
Brief Summary
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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.
Detailed Description
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Pain assessment will be conducted using a combination of self-reported, behavioral, and physiological measures: the Faces Pain Scale-Revised (FPS-R), the revised Face, Legs, Activity, Cry, Consolability (r-FLACC) behavioral pain scale, and heart rate monitoring. These multiple pain measures used provide a comprehensive evaluation of the child's pain experience.
The study will also investigate the influence of age, sex, and anatomical site (maxilla or mandible) on pain perception during SP administration. In addition, children's preferences for the two delivery systems (SP versus CS) will be recorded after both experiences to assess acceptance and comfort.
The findings of this research aim to contribute to improving pain management strategies in pediatric dentistry, supporting the use of more comfortable and child-friendly anesthesia delivery systems to enhance the dental experience and reduce anxiety in young patients.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Super Pen
Super Pen Computer-controlled Local Anesthesia delivery system
super pen
computer controlled local anesthesia delivery device
Conventional Syringe
Conventional metal syringe
No interventions assigned to this group
Interventions
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super pen
computer controlled local anesthesia delivery device
Eligibility Criteria
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Inclusion Criteria
2. Children who were healthy and medically fit; ASA I .
3. 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.
4. 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).
5. Children with positive consent forms approved by their parents/ legal guardians.
Exclusion Criteria
2. Children with any mental, visual, or auditory impairment.
3. Children who have medical or developmentally compromising conditions.
4. Children who had developmental delay problems.
5. Children with a history of chronic disease or use of medication that contraindicate the use of local anesthetics.
6. Children who had active pathosis at the injection site that could affect anesthetic assessment.
7. Patients who have negative (Class 2) or definitely negative (Class 1) behavior during preoperative behavioral assessments according to the Frankl Scale . - -
6 Years
12 Years
ALL
Yes
Sponsors
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Lamis D. Rajab
OTHER
Responsible Party
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Lamis D. Rajab
professor
Central Contacts
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Other Identifiers
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UJordanLamis2
Identifier Type: -
Identifier Source: org_study_id