Clinical trial · Interventional

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

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

NCT07210983CI-TRIAL-00096367LIPUSnot yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Curettage	—	UNRESOLVED	—
Jaw Cysts	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Low-Intensity Pulsed Ultrasound	Device	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Ultrasound Therapy Will Enhance Bone Healing and Recovery After Jaw Cyst Surgery
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.
interventionNames
1. Device: Low-Intensity Pulsed Ultrasound
type
SHAM_COMPARATOR
label
Sham-LIPUS therapy
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 60 Years

Show eligibility criteria text

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.

References

Publications (4)

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