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Studies

Interventional Not yet recruiting Phase 3

NCT07210983 on ClinicalTrials.gov

Low-Intensity Pulsed Ultrasound as an Adjunctive Therapy for Bone Regeneration Following Jaw Cyst Enucleation

Official title: Low-Intensity Pulsed Ultrasound as an Adjunctive Therapy for Bone Regeneration Following Jaw Cyst Enucleation With Curettage: A Randomized Controlled Trial

  • Sponsor: Sadam Elayah
  • Collaborators: Sichuan University
  • Enrollment: 29 (Estimated)
  • Study start: 2025-10-22 (Estimated)
  • Primary completion: 2026-03-02 (Estimated)
  • Study completion: 2026-05-30 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief Summary

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.

Conditions

  • Jaw Cysts
  • Curettage

Intervention / Treatment

  • Device: Low-Intensity Pulsed Ultrasound

Primary Outcome Measures

  • cyst cavity volume reduction (Time Frame: Measured from baseline (before cyst enucleation) to 3 months and 6 months post-treatment.)
    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). (Measured at baseline (pre-surgery), 3 months, and 6 months post-treatment.)
    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.

Study Officials

  • long jie, PhD (Principal Investigator) — Sichuan University