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Active, Not Recruiting

NCT Number: NCT06892808

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Chest Hospital

Shanghai, Xuhui, 200030, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Composite atrial arrhythmia recurrence

    Time frame: During the period from 3 months post-ablation to 12-month follow-up.

    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.

  2. Antiarrhythmic drug usage

    Time frame: At 12 months.

    Antiarrhythmic drug usage at 12 months.

  3. Change in Periodontal Inflamed Surface Area (PISA)

    Time frame: At 12 months

    Change in Periodontal Inflamed Surface Area (PISA) at 12 months

  4. Probing depth (PD) reduction ≥2 mm in ≥50% of sites.

    Time frame: At 12 months.

    Probing depth (PD) reduction ≥2 mm in ≥50% of sites.

  5. Bleeding on probing (BOP) rate reduction ≥30%.

    Time frame: At 12 months.

    Bleeding on probing (BOP) rate reduction ≥30%.

  6. Clinical attachment level (CAL) stability (change ≤1 mm).

    Time frame: At 12 months.

    Clinical attachment level (CAL) stability (change ≤1 mm).

Sponsors and collaborators

Lead sponsor

Xu Liu

Other

Collaborators

  • The First People's Hospital of Hefei City
  • The Second People's Hospital of Anhui Province

Registry information

Official study title

Effectiveness of Non-Surgical Periodontal Therapy on Atrial Fibrillation Recurrence After Radiofrequency Ablation in Patients with Atrial Fibrillation and High-Inflammatory Burden Periodontitis

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 25, 2025
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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