Jaw CystsPhase 3LIPUSNCT07210983
Low-Intensity Pulsed Ultrasound as an Adjunctive Therapy for Bone Regeneration Following Jaw Cyst Enucleation
A Phase 3 study testing Low-Intensity Pulsed Ultrasound in people with Jaw Cysts and Curettage, run by Sadam Elayah.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- What is being tested?
- Low-Intensity Pulsed Ultrasound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- 22 Oct 2025to 30 May 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- severe psychiatric disorders impairing compliance.
- acute infection.
- presence of a cardiac pacemaker.
- osteoporosis.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Low-Intensity Pulsed Ultrasound as an Adjunctive Therapy for Bone Regeneration Following Jaw Cyst Enucleation With Curettage: A Randomized Controlled Trial
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:
Read more
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.
Read the 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.
- Being tested
- Low-Intensity Pulsed Ultrasound
- Keywords
- Bone Regeneration, Hounsfield unit, Jaw Cysts, Low-intensity pulsed ultrasound, Three-Dimensional Volumetric Analysis, Bone Density
- Medical subject headings
- Jaw Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Intensity Pulsed UltrasoundDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Low-Intensity Pulsed Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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: 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)
Participants will rate the severity of pain at the surgical site, reflecting their comfort and recovery progress.
Measured: 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)
Measures functional limitations, pain/discomfort, and psychosocial impact related to oral health.
Measured: Pre-treatment, Day 10, 3 months, 6 months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start22 Oct 2025 (estimated)
- Primary completion2 Mar 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Jaw CystsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sadam Elayah
- Sponsor type
- University, hospital or other
- Collaborators
- Sichuan University
- Responsible party
- Sponsor-investigator, Sadam Elayah, Sichuan University
- Investigators
- long jie, PhD, Principal investigator, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210983
- Sponsor's protocol ID
- WCHSIRB-D-2021-280-R1
- Other IDs
- 31570950, 2024YFFK0376
- Acronym
- LIPUS
- Status last verified
- Sep 2025
- First submitted
- 30 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The research team may reconsider data sharing in the future once appropriate safeguards and approvals are established."
Publications
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.
PubMed 32145206Busse 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.
PubMed 11873920Lou 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.
PubMed 28953676
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Intensity Pulsed Ultrasound as an Adjunctive Therapy for Bone Regeneration Following Jaw Cyst Enucleation With Curettage: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07210983
- Acronym / sponsor ID
- LIPUS / WCHSIRB-D-2021-280-R1
- Keywords
- Bone Regeneration, Hounsfield unit, Jaw Cysts, Low-intensity pulsed ultrasound, Three-Dimensional Volumetric Analysis, Bone Density
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Sadam ElayahUniversity, hospital or other
- Collaborators
- Sichuan University
- Study start
- 22 Oct 2025 (estimated)
- Primary completion
- 2 Mar 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Therapy Will Enhance Bone Healing and Recovery After Jaw Cyst Surgery | Experimental | Device: Low-Intensity Pulsed UltrasoundUltrasound 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. |
| Sham-LIPUS therapy | Sham comparator | Device: Low-Intensity Pulsed UltrasoundPatients 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- severe psychiatric disorders impairing compliance.
- acute infection.
- presence of a cardiac pacemaker.
- osteoporosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Intensity Pulsed UltrasoundThe 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). | Device | Sham-LIPUS therapy, Ultrasound Therapy Will Enhance Bone Healing and Recovery After Jaw Cyst Surgery |
Primary outcome
cyst cavity volume reduction
Time frame: 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).
Time frame: 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.
2 secondary outcomes
Pain Intensity (VAS, 0-10) and Numbness Intensity (scale, 0-10)
Time frame: 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)
Time frame: Pre-treatment, Day 10, 3 months, 6 months post-treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Results publicationWei Y, Guo Y: Clinical applications of low-intensity pulsed ultrasound and its underlying mechanisms in dentistry. Applied Sciences 2022, 12(23):11898.
- Results publication: PubMed 32145206Gopalan 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.
- Results publication: PubMed 11873920Busse 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.
- Results publication: PubMed 28953676Lou 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.
- Individual participant dataSharing planned: Undecided. The research team may reconsider data sharing in the future once appropriate safeguards and approvals are established."
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
long jie, PhD principal investigator
Sichuan University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low-Intensity Pulsed Ultrasound in people with Jaw Cysts and Curettage, run by Sadam Elayah.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sadam Ahmed Elayah, PhD (18682960907 ext. 0086, s.elayah90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cyst cavity volume reduction (time frame: Time Frame: Measured from baseline (before cyst enucleation) to 3 months and 6 months post-treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07210983, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.