Curettage, Jaw Cysts
Conditions
Keywords
Bone Regeneration, Hounsfield unit, Jaw Cysts, Low-intensity pulsed ultrasound, Three-Dimensional Volumetric Analysis, Bone Density
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.
Detailed 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.
Interventions
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
Sichuan University
Sadam Elayah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cyst cavity volume reduction | Time Frame: Measured from baseline (before cyst enucleation) to 3 months and 6 months post-treatment. | 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). |
| Bone Density (CBCT, Relative Hounsfield Units). | Measured at baseline (pre-surgery), 3 months, and 6 months post-treatment. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Participants will rate the severity of pain at the surgical site, reflecting their comfort and recovery progress. |
| Oral Health-Related Quality of Life (OHIP-14, 0-56) | Pre-treatment, Day 10, 3 months, 6 months post-treatment. | Measures functional limitations, pain/discomfort, and psychosocial impact related to oral health. |
Contacts
Primary ContactSadam Ahmed Elayah, PhD
Outcome results
None listed