A Novel Bone Filling Material for Regenerative Surgery of Peri-implantitis Bone Defects: A Multicenter, Single-Blind, Randomized Controlled Clinical Study on Its Efficacy and Safety

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600124042

Enrollment

Unknown

Registered

2026-05-06

Start date

2025-08-17

Completion date

Unknown

Last updated

2026-05-11

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

Conditions

Peri-implantitis

Interventions

Purgo THE Graft Treatment Group:Purgo THE Graft Deproteinized Porcine Bone Powder

Bio-Oss Treatment Group:Bio-Oss Bone Powder

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Voluntary agreement to participate in the study and provision of signed informed consent. 2.Age = 18 years, medically stable patients, with no restrictions based on gender, ethnicity, educational level, or economic status. 3.Diagnosis of peri-implantitis with indications for regenerative surgical therapy, defined as having failed to achieve treatment endpoints following non-surgical therapy (presence of probing depth >5 mm or bleeding on probing at >1 site, excluding single-point bleeding) and presenting with an intrabony defect =3 mm.

Exclusion criteria

Exclusion criteria: 1. Under 18 years old (no right to sign informed consent themselves); 2. Infectious diseases such as active tuberculosis, HIV, syphilis, etc.; 3. Uncontrolled diabetes, or worsening diabetes during follow-up; 4. Long-term use of anticoagulant medication; 5. History of active angina, myocardial infarction, or cerebrovascular disease within the past six months; 6. Hepatitis, hepatitis B virus DNA >1000 cps/ml and/or abnormal liver function; 7. Cancer patients; 8. Kidney transplant patients or those with severely impaired kidney function; 9. Patients undergoing radiotherapy or chemotherapy; 10. Pregnant or breastfeeding; 11. Patients allergic to bone powder; 12. Patients with severe uncontrolled osteoporosis (bone density T-score =-2.5 and history of fragility fractures); 13. Patients who cannot contact or use deproteinized porcine bone powder due to religious beliefs, cultural customs, or personal reasons;

Design outcomes

Primary

Measure	Time frame
Peri-implant Marginal Bone Level Change;	—

Secondary

Measure	Time frame
Efficacy of Regenerative Surgery for Peri-implantitis;Graft-related Safety;	—

Countries

China

Contacts

Public ContactMingdeng Rong

Stomatological Hospital of Southern Medical University

23554800@qq.com+86 20 3431 4299

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026