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

NCT07210983 | Not Yet Recruiting Phase 3 DMC

• 3 other identifiers: WCHSIRB-D-2021-280-R1315709502024YFFK0376
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

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

Keywords

Bone Regeneration; Hounsfield unit; Jaw Cysts; Low-intensity pulsed ultrasound; Three-Dimensional Volumetric Analysis; Bone Density

Outcome Measures

Primary Outcomes (2)

• 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).

  Time Frame: Measured from baseline (before cyst enucleation) to 3 months and 6 months post-treatment.

• 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.

  Measured at baseline (pre-surgery), 3 months, and 6 months post-treatment.

Secondary Outcomes (2)

• Pain Intensity (VAS, 0-10) and Numbness Intensity (scale, 0-10)

  Recorded before LIPUS/sham therapy, on Day 5, Day 10, 3 months, and 6 months post-treatment.

• Oral Health-Related Quality of Life (OHIP-14, 0-56)

  Pre-treatment, Day 10, 3 months, 6 months post-treatment.

Study Arms (2)

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

EXPERIMENTAL

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.

Device: Low-Intensity Pulsed Ultrasound

Sham-LIPUS therapy

SHAM COMPARATOR

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.

Device: Low-Intensity Pulsed Ultrasound

Interventions

Low-Intensity Pulsed Ultrasound DEVICE

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).

Sham-LIPUS therapy; Ultrasound Therapy Will Enhance Bone Healing and Recovery After Jaw Cyst Surgery

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sadam Elayah: lead
• Sichuan University: collaborator

Related Publications (4)

• Wei Y, Guo Y: Clinical applications of low-intensity pulsed ultrasound and its underlying mechanisms in dentistry. Applied Sciences 2022, 12(23):11898.

  RESULT

• Gopalan A, Panneerselvam E, Doss GT, Ponvel K, Raja Vb K. Evaluation of Efficacy of Low Intensity Pulsed Ultrasound in Facilitating Mandibular Fracture Healing-A Blinded Randomized Controlled Clinical Trial. J Oral Maxillofac Surg. 2020 Jun;78(6):997.e1-997.e7. doi: 10.1016/j.joms.2020.01.036. Epub 2020 Feb 8.

  PMID: 32145206 RESULT

• Busse JW, Bhandari M, Kulkarni AV, Tunks E. The effect of low-intensity pulsed ultrasound therapy on time to fracture healing: a meta-analysis. CMAJ. 2002 Feb 19;166(4):437-41.

  PMID: 11873920 RESULT

• Lou S, Lv H, Li Z, Zhang L, Tang P. The effects of low-intensity pulsed ultrasound on fresh fracture: A meta-analysis. Medicine (Baltimore). 2017 Sep;96(39):e8181. doi: 10.1097/MD.0000000000008181.

  PMID: 28953676 RESULT

MeSH Terms

Conditions

Jaw Cysts

Condition Hierarchy (Ancestors)

Bone Cysts; Cysts; Neoplasms; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases

Study Officials

• long jie, PhD

  Sichuan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sadam Ahmed Elayah, PhD

CONTACT

18682960907; s.elayah90@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Before the group's assignment, all enucleation procedures will be carried out by the same surgeon to ensure consistency in surgical techniques. Three days after the surgery, patients will be randomly allocated to one of two groups using opaque, sealed envelopes. A nurse who is uninvolved in the research will open the randomization envelopes to reveal the assigned treatments: those in the ultrasound group will receive active LIPUS therapy, whereas the control group will be given sham LIPUS therapy, using an inactive device. Throughout the study, the surgeon, participants, outcome assessors, and statistician will remain unaware of the group allocation, maintaining a triple-blind design.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 7, 2025
• Study Start: October 22, 2025
• Primary Completion: March 2, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-09