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A Randomized Controlled Trial of Calcium Silicate Bioceramic Combined with Autogenous Bone for Reconstruction of Peri-Implantitis Bone Defects

Clinical Research on Key Technologies of Intelligent Diagnosis and Regenerative Repair for Peri-Implantitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123298
Enrollment
Unknown
Registered
2026-04-23
Start date
2026-04-30
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Peri-implantitis

Interventions

Reconstructive Surgery + Bio-Oss Bone Graft + Autogenous Bone (1:1 Mixture) group: During peri-implantitis reconstructive surgery, Bio-Oss bone graft material is mixed with autogenous bone at a 1:1 ra
Reconstructive Surgery + Calcium Silicate Bioceramic + Autogenous Bone (1:1 Mixture) group:During peri-implantitis reconstructive surgery, calcium silicate bioceramic bone graft material is mixed with

Sponsors

Stomatological Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18-80 years old (including 18 and 80), both male and female; 2. Diagnosed with peri-implantitis according to the 2018 World Workshop criteria; bone defect morphology classified as Class Ib (2/3 wall defect) according to Monje et al. (2019), with vertical bone loss of 25%-50% of the implant length; 3. Peri-implant keratinized gingiva width >= 2 mm; 4. Non-surgical treatment completed and re-evaluation meets surgical conditions: >= 3 months after non-surgical treatment, bleeding on probing sites < 25%, no suppuration; 5. Patient has signed informed consent and voluntarily agrees to undergo bone regeneration surgery.

Exclusion criteria

Exclusion criteria: 1. Individuals who smoke >=10 cigarettes per day and have no intention to quit; 2. Uncontrolled diabetes (HbA1c > 7.0%); 3. Long-term (>=3 years) history of oral or intravenous bisphosphonate use; 4. Severe coagulation disorders or currently receiving anticoagulant therapy that cannot be discontinued; 5. Pregnant or breastfeeding women; 6. Use of antibiotics or immunosuppressants within the past 4 weeks; 7. Obvious loosening of the implant (clinical mobility >=1 mm); 8. Other systemic diseases or local conditions considered by the investigator as unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
Radiographic Defect Fill (RDF);—

Secondary

MeasureTime frame
Radiographic Marginal Bone Level (MBL) Change;Probing Pocket Depth (PPD);Bleeding on Probing (BOP);Plaque Index (PLI);Graft Material Maintenance Volume;Postoperative Infection and Inflammation Status;Adverse Events (AE) and Serious Adverse Events (SAE);—

Countries

China

Contacts

Public ContactShulan Xu

Stomatological Hospital, Southern Medical University

xushulan_672588@smu.edu.cn+86 20 3430 4863

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026