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

Sadam Elayah

Status and phase: Not yet enrolling; Phase 3

Conditions: Jaw Cysts; Curettage

Treatments: Device: Low-Intensity Pulsed Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT07210983

2024YFFK0376 (Other Grant/Funding Number)

31570950 (Other Grant/Funding Number)

WCHSIRB-D-2021-280-R1

Details and patient eligibility

About

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.

Full description

This clinical trial will explore whether a special type of ultrasound treatment, called low-intensity pulsed ultrasound (LIPUS), can improve recovery after surgery to remove cysts in the jaw. Jaw cysts are fluid-filled sacs that can weaken the jawbone, cause swelling, and sometimes lead to pain or numbness. The standard treatment is surgical removal of the cyst, but healing can take a long time, and patients may continue to experience discomfort or reduced quality of life.

To investigate a possible solution, researchers will enroll 29 patients with a total of 33 jaw cysts. After their cysts are surgically removed, patients will be randomly divided into two groups:

The ultrasound group will receive 10 days of daily LIPUS therapy, beginning three days after surgery.

The control group will receive the same routine care but with a sham (inactive) device that looks and feels the same, so patients will not know if they are receiving real ultrasound.

The study will use a triple-blind design, meaning that the patients, the surgeon, and the evaluators will not know which group each patient is in. This ensures that the results are as reliable and unbiased as possible.

Recovery will be evaluated in several ways:

Patient experiences: Participants will report on their pain levels, numbness, anxiety, depression, and overall quality of life using standard questionnaires.

Medical monitoring: Doctors will check for side effects such as infection, skin irritation, or other complications.

Advanced imaging: Cone-beam CT (CBCT) scans will measure how much the cyst cavity shrinks and how well new bone forms. The scans will also be used to track bone density over time, which shows how strong and healthy the healing bone becomes.

All surgeries will be performed by the same experienced surgeon to ensure consistency. The study will follow strict international research standards, including ethics approval and clinical trial registration. All participants will be fully informed about the study and will provide written consent before joining.

Enrollment: 29 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• severe psychiatric disorders impairing compliance.
• acute infection.
• presence of a cardiac pacemaker.
• osteoporosis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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29 participants in 2 patient groups

Ultrasound Therapy Will Enhance Bone Healing and Recovery After Jaw Cyst Surgery

Experimental group

Description:

Ultrasound Therapy Arm (Intervention Group) Participants in this arm will undergo standard surgical treatment for jaw cysts (enucleation with curettage) followed by adjunctive low-intensity pulsed ultrasound (LIPUS) therapy. Starting on the third postoperative day, LIPUS will be delivered using the OSTEOTRON IV device (Japan) at a frequency of 1.5 MHz and an intensity of 30 mW/cm². Each treatment session will last 20 minutes, applied once daily for 10 consecutive days. A trained nurse will administer the therapy under standardized conditions, with patients in a supine position and a coupling gel applied to the skin overlying the surgical site. The LIPUS intervention is expected to stimulate bone regeneration, reduce postoperative pain and numbness, and improve patients' overall recovery and quality of life compared with surgery alone.

Treatment:

Device: Low-Intensity Pulsed Ultrasound

Sham-LIPUS therapy

Sham Comparator group

Description:

Patients in the sham-LIPUS group underwent the same surgical procedure and received the same postoperative care as the ultrasound group. Beginning on the third day after surgery, they attended 10 daily sessions of sham treatment, each lasting 20 minutes. During these sessions, the same OSTEOTRON IV device was used, but it was deactivated so that no ultrasound waves were delivered. The device was applied to the skin over the cyst site with coupling gel in a controlled environment, mimicking the active treatment procedure. This design ensured that patients experienced the same setup, duration, and sensations of treatment without receiving the therapeutic ultrasound, thereby maintaining blinding and allowing a direct comparison with the active LIPUS group.

Treatment:

Device: Low-Intensity Pulsed Ultrasound