Atrial FibrillationNCT06892808
Impact of Periodontal Therapy on AF Recurrence Post-Ablation in High-Inflammatory Burden Patients
A study testing Non-Surgical Periodontal Therapy and Background Periodontal Care in people with Atrial Fibrillation and Periodontitis, run by Xu Liu at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Periodontitis
- What is being tested?
- Non-Surgical Periodontal Therapy and Background Periodontal Care
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Non-Surgical Periodontal Therapy on Atrial Fibrillation Recurrence After Radiofrequency Ablation in Patients with Atrial Fibrillation and High-Inflammatory Burden Periodontitis
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
- Being tested
- Non-Surgical Periodontal Therapy, Background Periodontal Care
- Keywords
- Atrial Fibrillation, Periodontitis
- Medical subject headings
- Atrial Fibrillation, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Surgical Periodontal TherapyProcedure or surgery
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 CareProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Procedure: Background Periodontal Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 3 months post-ablation (end of blanking period) to the 12-month follow-up.
Secondary outcomes (6)
Composite atrial arrhythmia recurrence
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.
Measured: During the period from 3 months post-ablation to 12-month follow-up.
Antiarrhythmic drug usage
Antiarrhythmic drug usage at 12 months.
Measured: At 12 months.
Change in Periodontal Inflamed Surface Area (PISA)
Change in Periodontal Inflamed Surface Area (PISA) at 12 months
Measured: At 12 months
Probing depth (PD) reduction ≥2 mm in ≥50% of sites.
Probing depth (PD) reduction ≥2 mm in ≥50% of sites.
Measured: At 12 months.
Bleeding on probing (BOP) rate reduction ≥30%.
Bleeding on probing (BOP) rate reduction ≥30%.
Measured: At 12 months.
Clinical attachment level (CAL) stability (change ≤1 mm).
Clinical attachment level (CAL) stability (change ≤1 mm).
Measured: At 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start5 Mar 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xu Liu
- Sponsor type
- University, hospital or other
- Collaborators
- The First People's Hospital of Hefei, The Second People's Hospital of Anhui Province
- Responsible party
- Sponsor-investigator, Xu Liu, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892808
- Sponsor's protocol ID
- HIPDAF
- Status last verified
- Mar 2025
- First submitted
- 2 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Non-Surgical Periodontal Therapy on Atrial Fibrillation Recurrence After Radiofrequency Ablation in Patients with Atrial Fibrillation and High-Inflammatory Burden Periodontitis
- ClinicalTrials.gov ID
- NCT06892808
- Acronym / sponsor ID
- HIPDAF
- Conditions
- Atrial Fibrillation, Periodontitis
- Keywords
- Atrial Fibrillation, Periodontitis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Xu LiuUniversity, hospital or other
- Collaborators
- The First People's Hospital of Hefei, The Second People's Hospital of Anhui Province
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Procedure: Non-Surgical Periodontal Therapy, Procedure: Background Periodontal CareNon-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). |
| Control group | Active comparator | Procedure: Background Periodontal CareAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Surgical Periodontal TherapyUnder 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 or surgery | Treatment group |
| Background Periodontal CareAll 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 or surgery | Control group, Treatment group |
Primary outcome
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.
6 secondary outcomes
Composite atrial arrhythmia recurrence
Time frame: During the period from 3 months post-ablation to 12-month follow-up.
Antiarrhythmic drug usage
Time frame: At 12 months.
Change in Periodontal Inflamed Surface Area (PISA)
Time frame: At 12 months
Probing depth (PD) reduction ≥2 mm in ≥50% of sites.
Time frame: At 12 months.
Bleeding on probing (BOP) rate reduction ≥30%.
Time frame: At 12 months.
Clinical attachment level (CAL) stability (change ≤1 mm).
Time frame: At 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Surgical Periodontal Therapy and Background Periodontal Care in people with Atrial Fibrillation and Periodontitis, run by Xu Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.