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| Name | Class |
|---|---|
| The First People's Hospital of Hefei City | UNKNOWN |
| The Second People's Hospital of Anhui Province | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | 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). |
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| Control group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Surgical Periodontal Therapy | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial fibrillation (AF) episodes lasting ≥30 seconds occurring | Atrial fibrillation (AF) episodes lasting ≥30 seconds occurring from 3 months post-ablation (end of blanking period) to the 12-month follow-up. | From 3 months post-ablation (end of blanking period) to the 12-month follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite atrial arrhythmia recurrence | AF, atrial flutter (AFL), or atrial tachycardia (AT) episodes lasting ≥30 seconds during the period from 3 months post-ablation to 12-month follow-up. | During the period from 3 months post-ablation to 12-month follow-up. |
| Antiarrhythmic drug usage |
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | Xuhui | 200030 | China |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Background Periodontal Care | Procedure | 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. |
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Antiarrhythmic drug usage at 12 months. |
| At 12 months. |
| Change in Periodontal Inflamed Surface Area (PISA) | Change in Periodontal Inflamed Surface Area (PISA) at 12 months | At 12 months |
| Probing depth (PD) reduction ≥2 mm in ≥50% of sites. | Probing depth (PD) reduction ≥2 mm in ≥50% of sites. | At 12 months. |
| Bleeding on probing (BOP) rate reduction ≥30%. | Bleeding on probing (BOP) rate reduction ≥30%. | At 12 months. |
| Clinical attachment level (CAL) stability (change ≤1 mm). | Clinical attachment level (CAL) stability (change ≤1 mm). | At 12 months. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |