Low-Intensity Pulsed Ultrasound (LIPUS) is being investigated as a medical device therapy for enhancing bone regeneration, particularly after jaw cyst enucleation procedures. Researchers affiliated with Sichuan University and Sadam Elayah are sponsoring a clinical trial to test the safety and efficacy of this technology for patients recovering from curettage for jaw cysts. The study, which is not yet recruiting, highlights the growing interest in LIPUS as a non-invasive tool to optimize bone healing.
This development is relevant for clinical researchers, regulatory teams, and medical device quality professionals tracking advancements in therapy optimization.
Why does it matter?
Jaw cyst enucleation is a frequent surgical intervention, often requiring substantial post-operative bone regeneration. Conventional healing approaches may benefit from advancements like LIPUS to minimize complications and expedite recovery. This technology could provide more effective therapeutic pathways for patients while also advancing device-based interventions in dental and orthopedic applications.
What is Low-Intensity Pulsed Ultrasound?
LIPUS is a non-invasive medical device technology that uses sound waves to promote tissue repair and bone formation. It operates through mechanical stimulation, resulting in cellular-level responses that accelerate healing. The device’s intended purpose in this clinical trial is to act as an adjunct to surgical intervention, enhancing the natural regeneratory processes that occur post-cyst enucleation.
Mechanism of action
LIPUS works by producing low-intensity acoustic energy that stimulates the affected area, increasing blood flow and encouraging osteoblast activity. This could significantly improve the post-operative bone regeneration process while reducing the likelihood of incomplete healing or complications.
What will the study assess?
The trial’s focus will be on evaluating the performance and safety of LIPUS as an adjunctive therapy during patients’ post-surgical recovery from jaw cyst enucleation. By measuring outcomes such as bone density and healing time, the research will aim to establish evidence-based claims regarding the device’s effectiveness.
Current trial status
As of the publication date, October 7, 2025, the study is listed as “not yet recruiting” on the ClinicalTrials.gov database. This indicates researchers are in preparatory phases, finalizing study protocols and recruitment strategies to ensure compliance with international regulatory standards.
Regulatory considerations
This study aligns with the regulatory emphasis on device performance and safety validation outlined in MDR Annex XIV. The research will provide insights into the device’s efficacy and clinical utility in addressing unmet therapeutic needs.
Frequently Asked Questions
- What are jaw cysts?
Jaw cysts are fluid-filled growths within the jawbone that can cause structural deficiencies, pain, and complications requiring surgical removal. - Is LIPUS FDA-cleared?
Certain LIPUS devices have received FDA clearance for other indications, but this specific application is undergoing clinical evaluation. - How does LIPUS improve bone healing?
The device uses acoustic energy to stimulate cellular activity, which promotes enhanced bone density and faster recovery.
Implications for the field
For regulatory teams, clinicians, and stakeholders in medical device development, this research can serve as a key reference point for understanding the expanding role of LIPUS. Monitoring the study’s results could offer insights into future approval pathways and optimization strategies for similar therapeutic devices.
Disclaimer
This content is intended for informational purposes only. It does not constitute legal or medical advice. Always refer to official regulatory and clinical trial documentation.
Link to full study record
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07210983?term=medical+device