Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT07292194
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.
Detailed Description:
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.
Study:
NCT07292194
Study Brief:
Protocol Section:
NCT07292194