MedTrace Logo

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

NCT07210983 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-10-07

No results posted yet for this study

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

Interventions

DEVICE

Low-Intensity Pulsed Ultrasound

The 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).

Sponsors & Collaborators

  • Sichuan University

    collaborator OTHER

  • Sadam Elayah

    lead OTHER

Principal Investigators

  • long jie, PhD · Sichuan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-22
Primary Completion
2026-03-02
Completion
2026-05-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07210983 on ClinicalTrials.gov