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Clinical effect of non-surgical periodontal therapy combined with PCI on acute coronary syndrome: a multi-center prospective clinical trial

Clinical effect of non-surgical periodontal therapy combined with PCI on acute coronary syndrome: a multi-center prospective clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036462
Enrollment
Unknown
Registered
2020-08-23
Start date
2020-11-01
Completion date
Unknown
Last updated
2020-09-14

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

Conditions

Acute coronary syndrome

Interventions

Experimental group:periodontal non-surgical treatment combined with PCI
Control group:PCI only

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: 1. Male or female aged 18 to 70 years; 2. Patients with acute coronary syndrome (ACS), GRACE score =0.2 mV; (3) Cardiac troponin (cTn) T and I are higher than the upper limit of normal; 3. For patients with stage II-IV periodontitis, according to the definition of periodontitis in the new international classification of periodontal disease and implant peri-implant disease in 2018: the most severe site of adjacent surface attachment loss >=3mm, PD is greater than 4mm, imaging Upper bone resorption >=15%, with or without tooth loss caused by periodontitis; 4. Receive percutaneous coronary intervention (PCI).

Exclusion criteria

Exclusion criteria: 1. Patients who need coronary artery bypass grafting (CABG); 2. Patients with severe arrhythmia and hemodynamic instability during hospitalization; 3. Patients after cardiopulmonary resuscitation; 4. Cancer patients; 5. Patients with limited life expectancy less than 1 year; 6. Use immunosuppressants or NSAIDs; 7. Edentulous patients; 8. Patients with low platelet or coagulation function, previous history of intracerebral hemorrhage or other hemorrhagic diseases, unable to accept periodontal non-surgical treatment; 9. Those who have received periodontal treatment in the past 3 months; 10. Women who are pregnant, lactating or planning to have a pregnancy during this study; 11. Severe cardiac insufficiency (NYHA >=3, New York cardiothoracic Association); 12. Patients with hepatic and renal insufficiency (ALT or ast > 20uln, ALP > 20uln, bil > 10uln, EGFR < 15ml / min / 1.73m2); 13. Patients with acute cerebral infarction within 3 months; 14. Patients with respiratory failure or severe lung disease.

Design outcomes

Primary

MeasureTime frame
Gensini score of coronary angiography;

Secondary

MeasureTime frame
Color Doppler echocardiography of heart;sICAM-1;sVCAM-1;cIMT;FMD;hs-CRP;NT-Pro BNP;GDF-15;Quality of life assessment score;Angina score;Motor ability score;Periodontal clinical indicators;Major adverse cardiovascular events;Number of adverse events;

Countries

China

Contacts

Public ContactZhongchen Song

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

szhongchen@sina.com+86 21 53315841

Outcome results

None listed

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