About this trial
This study tested whether low-intensity pulsed ultrasound (LIPUS) could help patients recover better after surgery to remove jaw cysts.
A total of 29 patients with 33 jaw cysts were included. After surgery, they were randomly assigned to two groups:
Ultrasound group (17 patients, 18 cysts): received daily LIPUS therapy for 10 days.
Control group (12 patients, 15 cysts): received the same care but with a sham (inactive) device.
The study was triple-blinded, meaning that the patients, the surgeon, and the evaluators did not know who was receiving real or sham treatment.
Researchers measured recovery in several ways:
Patient reports: pain, numbness, anxiety/depression, and oral health-related quality of life.
Clinician monitoring: checked for any side effects (like infection or burns). Imaging tests (CBCT scans): tracked how well bone healed by measuring changes in cyst cavity size (volume reduction) and new bone density.
All patients had the same type of surgery, performed by the same surgeon, and all provided written informed consent. The study followed international ethics and trial registration standards.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
age ≥18 years.
having undergone cyst enucleation with curettage.
postoperative histopathological confirmation of a jaw cyst.
willingness to complete 10 days of standardized LIPUS therapy
Disqualifiers
severe psychiatric disorders impairing compliance.
acute infection.
presence of a cardiac pacemaker.
osteoporosis.
Trial design
Parallel
Treatments tested in this trial
Low-Intensity Pulsed Ultrasound
DeviceThe LIPUS therapy protocol was administered by a trained nurse following standardized procedures. Starting on the third day post-enucleation, patients in the ultrasound group underwent LIPUS therapy using the OSTEOTRON IV device (Japan), set at a frequency of 1.5 MHz and an intensity of 30 mW/cm², with 20-minute sessions for 10 consecutive days (Fig. 1). Treatments were conducted in a temperature-controlled environment, with patients positioned supine. Prior to each session, the skin over the cyst site was cleansed and coated with ultrasound transmission gel (Hinuo, Qingdao, China).
Treatment groups
Trial outcomes
Primary outcomes
cyst cavity volume reduction
The primary outcome measure of this trial will be cyst cavity volume reduction, assessed using cone-beam computed tomography (CBCT). Volumetric measurements of the cystic cavity (preoperative) and the residual cavity (at 3 and 6 months post-treatment) will be performed with Mimics 21.0 software (Materialise, Belgium).
Bone Density (CBCT, Relative Hounsfield Units).
CBCT scans will quantify the mineral density of newly formed bone in the cyst site. The density will be expressed as relative Hounsfield Units (HU), using the nearest tooth's dentine as an internal reference. A relative HU value approaching 1 indicates higher bone mineralization, reflecting better bone regeneration after surgery with or without LIPUS therapy.
Secondary outcomes
Pain Intensity (VAS, 0-10) and Numbness Intensity (scale, 0-10)
Participants will rate the severity of pain at the surgical site, reflecting their comfort and recovery progress.
Oral Health-Related Quality of Life (OHIP-14, 0-56)
Measures functional limitations, pain/discomfort, and psychosocial impact related to oral health.
Locations
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