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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06892808
Enrollment
212
Registered
2025-03-25
Start date
2025-03-05
Completion date
2026-08-01
Last updated
2025-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Periodontitis

Keywords

Atrial Fibrillation, Periodontitis

Brief 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).

Interventions

PROCEDURENon-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).

PROCEDUREBackground 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.

Sponsors

The First People's Hospital of Hefei City
CollaboratorUNKNOWN
The Second People's Hospital of Anhui Province
CollaboratorOTHER
Xu Liu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Atrial fibrillation (AF) episodes lasting ≥30 seconds occurringFrom 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

MeasureTime frameDescription
Antiarrhythmic drug usageAt 12 months.Antiarrhythmic drug usage at 12 months.
Change in Periodontal Inflamed Surface Area (PISA)At 12 monthsChange in Periodontal Inflamed Surface Area (PISA) at 12 months
Composite atrial arrhythmia recurrenceDuring 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.
Bleeding on probing (BOP) rate reduction ≥30%.At 12 months.Bleeding on probing (BOP) rate reduction ≥30%.
Clinical attachment level (CAL) stability (change ≤1 mm).At 12 months.Clinical attachment level (CAL) stability (change ≤1 mm).
Probing depth (PD) reduction ≥2 mm in ≥50% of sites.At 12 months.Probing depth (PD) reduction ≥2 mm in ≥50% of sites.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026