Evaluation of a Photobiomodulation Device for Dental Analgesia in Children Aged 6 to 12 Years

What this Trial Is About

This research aims to evaluate photobiomodulation (PBM), a non-invasive light therapy, to reduce discomfort during dental treatments for children aged 6 to 12 years. The study focuses on testing PBM's ability to provide dental analgesia as an alternative to traditional local anesthetic injections, which can cause anxiety and fear in pediatric patients. The trial includes three clinical studies involving 200 school-aged children undergoing routine dental procedures to assess PBM's effectiveness on tooth and soft tissue pain relief and anxiety reduction. The study uses an intra-oral PBM device with a near-infrared laser tip that emits light able to penetrate tooth and bone to block nerve signals. In the first study, one 20-second light burst is applied to the tooth before sensitivity tests and gum probing. The second study applies PBM at the injection site before local anesthesia to evaluate if it reduces injection discomfort. The third study tests PBM as an alternative to numbing injections for simple fillings in baby teeth, with additional light bursts given every 20 minutes if needed. Control groups receive no PBM or standard topical benzocaine and local anesthesia. Participants will undergo various assessments including response to cold pulp testing, gum probing, pain and anxiety ratings before, during, and after dental procedures. Researchers will monitor cooperative behavior and document pain levels both by physicians and self-report. The study measures the duration of analgesia from PBM and compares it to standard treatments. The total participation includes these dental visits with follow-up assessments to evaluate safety and effectiveness of PBM in reducing dental discomfort in children.

Photobiomodulation and Tooth Analgesia