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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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 cy

Первичные конечные точки

• cyst cavity volume reduction [Срок оценки: Time Frame: Measured from baseline (before cyst enucleation) to 3 months and 6 months post-treatment.]
• Bone Density (CBCT, Relative Hounsfield Units). [Срок оценки: Measured at baseline (pre-surgery), 3 months, and 6 months post-treatment.]

Вторичные конечные точки (2)

• Pain Intensity (VAS, 0-10) and Numbness Intensity (scale, 0-10) [Срок оценки: 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) [Срок оценки: Pre-treatment, Day 10, 3 months, 6 months post-treatment.]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

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

Идентификаторы

NCT: NCT07210983 · WCHSIRB-D-2021-280-R1 · 31570950 · 2024YFFK0376

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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