Impact of Periodontal Therapy on AF Recurrence Post-Ablation in High-Inflammatory Burden Patients

Xu Liu

Status: Active, not recruiting

Conditions: Periodontitis; Atrial Fibrillation

Treatments: Procedure: Background Periodontal Care; Procedure: Non-Surgical Periodontal Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06892808

HIPDAF

Details and patient eligibility

About

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).

Enrollment: 212 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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212 participants in 2 patient groups

Treatment group

Experimental group

Description:

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).

Treatment:

Procedure: Non-Surgical Periodontal Therapy

Procedure: Background Periodontal Care

Control group

Active Comparator group

Description:

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.

Treatment:

Procedure: Background Periodontal Care