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

NCT06892808 | Active Not Recruiting DMC

• 1 other identifier: HIPDAF
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

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).

Conditions

Atrial Fibrillation; Periodontitis

Keywords

Atrial Fibrillation; Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (6)

• Composite atrial arrhythmia recurrence

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

• Antiarrhythmic drug usage

  At 12 months.

• Change in Periodontal Inflamed Surface Area (PISA)

  At 12 months

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

  At 12 months.

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

  At 12 months.

Study Arms (2)

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).

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

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.

Procedure: Background Periodontal Care

Interventions

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).

Treatment group

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.

Control group; Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Xu Liu: lead
• The First People's Hospital of Hefei City: collaborator
• The Second People's Hospital of Anhui Province: collaborator

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Xuhui, 200030, China

Location

MeSH Terms

Conditions

Atrial Fibrillation; Periodontitis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: March 25, 2025
• Study Start: March 5, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)