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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:
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.
This clinical study aims to evaluate and compare the pain perception of pediatric patients aged 6-12 years during local anesthetic (LA) infiltration for primary teeth using the Computer-Controlled Local Anesthetic Delivery (CCLAD) system-Super Pen (SP)-versus the Conventional Syringe (CS) technique. The study follows a split-mouth crossover design, in which each child receives anesthesia using both techniques in separate appointments, allowing for direct within-subject comparison.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Super Pen | Active Comparator | Super Pen Computer-controlled Local Anesthesia delivery system |
|
| Conventional Syringe | No Intervention | Conventional metal syringe |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| super pen | Device | computer controlled local anesthesia delivery device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lamis | Amman | Jordan |
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| ID | Term |
|---|---|
| D014098 | Toothache |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
| D010146 | Pain |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |