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Clinical Trials in China / NCT06892808
Active, not recruiting Not applicable

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

NCT06892808 · tracked via the Priya Life Science China tracker
Sponsor
Xu Liu
Phase
Not applicable
Started
2025-03-05
Last updated
2025-03-25

Condition(s) studied

Atrial FibrillationPeriodontitis

Investigational drug(s) / intervention(s)

Non-Surgical Periodontal TherapyBackground Periodontal Care

Non-Surgical Periodontal Therapy: 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).

Background Periodontal Care: 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.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Atrial fibrillation (AF) episodes lasting ≥30 seconds occurring — 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.

Trial sites (1)

FacilityCityRegionStatus
Shanghai Chest Hospital Shanghai Xuhui

More Xu Liu trials in China

Optimal Ablation Strategies for Persistent AF With HF Active, not recruiting
Efficacy of Mavacamten in Patients With Symptomatic Latent Obstructive Hypertrophic Cardiomyopathy Active, not recruiting
EGM Guided PFA for PerAF Active, not recruiting
Pulsed-Field Ablation With/Without Electrogram Mapping Active, not recruiting

Other trials for the same condition

Nd:YAG Laser Effects on Subgingival Microbiota in Stage III-IV Periodontitis Active, not recruiting
Effects of Non-surgical Periodontal Therapy on Cardiovascular Risk Starting soon
NOACs Use in AF or VTE (SUNSHINE Registry) Recruiting
Quantitative Superior Vena Cava Isolation in Addition to Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation Recruiting
Low-dose NOAC Versus GDMT After LAAO Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06892808 on ClinicalTrials.gov ↗ ← All trials in China