Impact of Periodontal Therapy on AF Recurrence Post-Ablation in High-Inflammatory Burden Patients
NCT ID: NCT06892808
Last Updated: 2025-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
212 participants
INTERVENTIONAL
2025-03-05
2026-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment group
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).
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.
Control group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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The First People's Hospital of Hefei City
UNKNOWN
The Second People's Hospital of Anhui Province
OTHER
Xu Liu
OTHER
Responsible Party
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Xu Liu
Professor
Locations
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Shanghai Chest Hospital
Shanghai, Xuhui, China
Countries
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Other Identifiers
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HIPDAF
Identifier Type: -
Identifier Source: org_study_id
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