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Low-intensity pulsed ultrasound (LIPUS) promotes dental implant osseointegration in patients with type 2 diabetes: a randomised controlled clinical study

Low-intensity pulsed ultrasound (LIPUS) promotes dental implant osseointegration in patients with type 2 diabetes: a randomised controlled clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101453
Enrollment
Unknown
Registered
2025-04-25
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Dentition defect

Interventions

Treatment group:After 2 weeks of implant placement, the experimental group irradiated the implant site corresponding to the skin area of the face with LIPUS for 20 minutes once a day for 2 days
Control group:The LIPUS treatment device is not turned on, and other operating procedures are the same as those in the experimental group

Sponsors

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Type 2 diabetes included 1. Patients with confirmed type 2 diabetes mellitus, with a previous history of diabetes confirmed by a physician's report; 2. All patients are actively receiving treatment and are receiving oral medications, insulin, or combination therapy. The patient's diabetes status was moderately or well controlled, with preoperative HbA1c levels between 6% and 8%. HbA1c levels were measured in the same laboratory one week prior to surgery. Implant treatment inclusion 1. Adult patients aged 18 to 70 years (inclusive); 2. Tooth loss requires implant restoration, the missing tooth has been more than 3 months, can treat the patient with an implant-supported fixed restoration, for patients with multiple implants, only one missing area is selected domain; 3. The alveolar bone width, height and edentulous space at the implant implant site are sufficient, and pure titanium or titanium alloy implants with a diameter of >=3.0 mm and a height of >=8 mm can be implanted, without additional bone augmentation surgery; 4. Before the implementation of any study-related experimental procedures, the experimenter voluntarily signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with type 1 diabetes mellitus, patients with HbA1c levels higher than 8% or less than 6%; 2. Local inflammation of adjacent teeth, including uncontrolled periodontitis and untreated acute and chronic apical periodontitis; 3. Suffering from systemic diseases that affect bone healing, wound healing and dental implant treatment, and the general condition cannot tolerate conventional implant surgery; 4. 10 cigarettes/tobacco equivalents/chewing tobacco > per day; 5. Patients who are being treated or have been treated with drugs that may affect bone metabolism (such as bisphosphonates) that may affect bone metabolism; 6. Have received maxillofacial radiotherapy;

Design outcomes

Primary

MeasureTime frame
Implant Stability Quotient (ISQ);

Secondary

MeasureTime frame
Implant success rate;Peri-implant marginal bone height;Peri-implant marginal bone resorption;

Countries

China

Contacts

Public ContactChun Xu

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

imxuchun@163.com+86 21 53315691

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026