Effectiveness of Non-Surgical Periodontal Therapy on Atrial Fibrillation Recurrence After Radiofrequency Ablation in Patients with Atrial Fibrillation and High-Inflammatory Burden Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Atrial fibrillation (AF) episodes lasting ≥30 seconds occurring
研究概览
简要总结
Comparison of Non-Surgical Periodontal Therapy versus Background Periodontal Care in Reducing Atrial Fibrillation Recurrence in Patients with AF and Periodontitis: A Randomized Trial with Two Arms (Background Therapy Group vs. Conventional Non-Surgical Therapy Group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years. Diagnosed with atrial fibrillation (AF) and undergoing first-time catheter ablation.
- •Diagnosed with periodontitis (2017 World Workshop classification) and periodontal inflamed surface area (PISA) >500 mm².
- •Willing and able to provide written informed consent.
排除标准
- •Requiring periodontal surgical intervention, e.g., flap surgery, bone grafting. Non-surgical periodontal therapy (e.g., scaling and root planing) within the past 6 months.
- •Active systemic infection, e.g., sepsis, tuberculosis. Current immunosuppressive therapy, e.g., post-transplant medications, long-term corticosteroids.
- •Chronic hepatitis B or HIV infection. Chronic systemic antibiotic use (>4 weeks). Pregnancy or lactation. Anticipated survival <12 months.
研究组 & 干预措施
Treatment group
Non-Surgical Periodontal Therapy Protocol Under local anesthesia, full-mouth debridement (supragingival and subgingival scaling and root planing, FM-SRP) was performed by an experienced periodontist, initiated within 48 hours post-atrial fibrillation ablation and completed in two sessions within 48 hours. Polishing was performed using a rubber cup with prophylaxis paste. The procedure utilized Gracey curettes and piezoelectric ultrasonic tips combined with a force-controlled system.
Postoperative Care Immediate Care:Local Adjunctive Therapy: 2% minocycline gel was injected into deep periodontal pockets (PD ≥5mm). Antimicrobial Rinse: 0.12% chlorhexidine solution (15 mL, 30-second rinse twice daily) for 14 days.
Follow-Up Intervention At the 6-month follow-up, additional oral debridement was performed in the intervention group if indicated by the presence of bleeding points and/or increased probing pocket depth (PPD).
干预措施: Non-Surgical Periodontal Therapy (Procedure)
Treatment group
Non-Surgical Periodontal Therapy Protocol Under local anesthesia, full-mouth debridement (supragingival and subgingival scaling and root planing, FM-SRP) was performed by an experienced periodontist, initiated within 48 hours post-atrial fibrillation ablation and completed in two sessions within 48 hours. Polishing was performed using a rubber cup with prophylaxis paste. The procedure utilized Gracey curettes and piezoelectric ultrasonic tips combined with a force-controlled system.
Postoperative Care Immediate Care:Local Adjunctive Therapy: 2% minocycline gel was injected into deep periodontal pockets (PD ≥5mm). Antimicrobial Rinse: 0.12% chlorhexidine solution (15 mL, 30-second rinse twice daily) for 14 days.
Follow-Up Intervention At the 6-month follow-up, additional oral debridement was performed in the intervention group if indicated by the presence of bleeding points and/or increased probing pocket depth (PPD).
干预措施: Background Periodontal Care (Procedure)
Control group
All study participants received oral hygiene instruction using the modified Bass technique. At baseline, supragingival deposits (dental plaque and calculus) were removed with an ultrasonic scaler or rubber cup with prophylaxis paste. To maintain blinding, simulated subgingival instrumentation sounds were played during the procedure for control group participants.
干预措施: Background Periodontal Care (Procedure)
结局指标
主要结局
Atrial fibrillation (AF) episodes lasting ≥30 seconds occurring
时间窗: From 3 months post-ablation (end of blanking period) to the 12-month follow-up.
Atrial fibrillation (AF) episodes lasting ≥30 seconds occurring from 3 months post-ablation (end of blanking period) to the 12-month follow-up.
次要结局
- Composite atrial arrhythmia recurrence(During the period from 3 months post-ablation to 12-month follow-up.)
- Antiarrhythmic drug usage(At 12 months.)
- Change in Periodontal Inflamed Surface Area (PISA)(At 12 months)
- Probing depth (PD) reduction ≥2 mm in ≥50% of sites.(At 12 months.)
- Bleeding on probing (BOP) rate reduction ≥30%.(At 12 months.)
- Clinical attachment level (CAL) stability (change ≤1 mm).(At 12 months.)
研究者
Xu Liu
Professor
Shanghai Chest Hospital