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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250616017

Enrollment

Registered

2025-06-16

Start date

2023-10-15

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Numbness, Hospital Anxiety, Depression, and Cystic Volume Jaw Cysts

Interventions

Beginning on the third post-curettage day, patients in the ultrasound group received LIPUS therapy using the OSTEOTRON IV device (Japan) with 20 minute sessions for 10 consecutive days.,Beginning on

Experimental Device,Sham Comparator Device

Jaw Cyst Curettage with Low-Intensity Pulsed Ultrasound, Jaw Cyst Curettage with Inactive Low-Intensity Pulsed Ultrasound

Eligibility

Sex/Gender

All

Age

18 Years to 38 Years

Inclusion criteria

Inclusion criteria: 1. Age more than 18 years. 2. Undergone cyst curettage. 3. Postoperative pathological confirmation of jaw cyst. 4. willingness to complete 10 days of standardized LIPUS treatment

Exclusion criteria

Exclusion criteria: 1. Severe psychiatric disorders impairing compliance. 2. Acute infection. 3. Presence of cardiac pacemakers. 4. Osteoporosis.

Design outcomes

Primary

Measure	Time frame
Cyst volume Before the LIPUS, 3rd month, and 6th month postoperative. Cone-beam computed tomography (CBCT)	—

Secondary

Measure	Time frame
Pain Before the LIPUS, 5th day, 10th day, 3rd month, and 6th month postoperative. Using Visual Analog Scale which ranges between 0 (no pain) and 10 (worst pain) ,Hospital Anxiety and Depression Before the LIPUS, 10th day, 3rd month, and 6th month postoperative. Using included 7 items each (0 to 3 points, item), Total score: 0 to 21 (0 to 7: Normal, 8 to 10: Mild, 11 to 14: Moderate, and 15 to 21: Severe anxiety and depression. ,Oral Health Impact Profile Before the LIPUS, 10th day, 3rd month, and 6th month postoperative. Oral Health Impact Profile 14 to assess the Functional limitation, pain/discomfort, disability, and psychological/social impact,Adverse medical device events, such as infection, allergic reactions, cutaneous burns and ulcerations, and signs of inflammation. Throughout the follow-up period The assessor clinically monitored adverse events	—

Measure

Time frame

Pain Before the LIPUS, 5th day, 10th day, 3rd month, and 6th month postoperative. Using Visual Analog Scale which ranges between 0 (no pain) and 10 (worst pain) ,Hospital Anxiety and Depression Before the LIPUS, 10th day, 3rd month, and 6th month postoperative. Using included 7 items each (0 to 3 points, item), Total score: 0 to 21 (0 to 7: Normal, 8 to 10: Mild, 11 to 14: Moderate, and 15 to 21: Severe anxiety and depression. ,Oral Health Impact Profile Before the LIPUS, 10th day, 3rd month, and 6th month postoperative. Oral Health Impact Profile 14 to assess the Functional limitation, pain/discomfort, disability, and psychological/social impact,Adverse medical device events, such as infection, allergic reactions, cutaneous burns and ulcerations, and signs of inflammation. Throughout the follow-up period The assessor clinically monitored adverse events

—

Countries

China

Contacts

Public ContactJie Long

Sichuan University

dr.jielong@hotmail.com19141202117

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026