Acute Myocardial Infarction (AMI)NCT06745141
Myocardial Infarction and Periodontitis: Periodontal Health Intervention.
A study testing Periodontal surgery in people with Acute Myocardial Infarction (AMI) and Periodontal Disease, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
The aim of this study is to establish a shared database of acute myocardial infarction patients with periodontitis, to clarify the clinical benefits of periodontitis intervention on acute myocardial infarction patients through simulated RCT study, and to establish a high-level database of acute myocardial infarction… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Acute Myocardial Infarction (AMI), Periodontal Disease
- What is being tested?
- Periodontal surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 31 Dec 2025
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1)Patients diagnosed with ST-segment elevation myocardial infarction (STEMI). 2)Patients with severe periodontal disease, defined as:
- 5 teeth with clinical attachment loss (CAL) ≥ 4 mm.
- Subgingival probing depth (PD) ≥ 6 mm. ③≥ 8 teeth with gingival bleeding on probing (BOP). 3）Age ≥30 years. 4）Written informed consent provided.
Who cannot join
- 1) under 30 years old; 2) HIV positive, chronic inflammation, tumor disease, drug dependence, use of anticonvulsants, use of immunosuppressive agents, pregnancy, and lactation; 3) significant tooth loss (number of remaining teeth < 8); 4) long hospital stay (>10 days), new myocardial infarction before randomization, and stent thrombosis; 5) Refusal to sign informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200092
Jiawen Wu, 17717070557, chloewuu@foxmail.com
About this study
Official title: Oral Health Intervention Study in Patients with Myocardial Infarction and Periodontal Disease: a Simulated RCT Trial
The aim of this study is to establish a shared database of acute myocardial infarction patients with periodontitis, to clarify the clinical benefits of periodontitis intervention on acute myocardial infarction patients through simulated RCT study, and to establish a high-level database of acute myocardial infarction patients with periodontitis, so as to promote the application of oral health intervention in clinical practice.
- Being tested
- Periodontal surgery
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal surgeryProcedure or surgery
In the intervention group, patients underwent a comprehensive periodontal evaluation conducted by periodontists at a dental clinic. All permanent teeth, except for third molars, were assessed using dental mirrors and periodontal probes. Each tooth was examined at four sites (vestibular, distal, lingual, and mesial) to evaluate visible plaque, probing depth, probing bleeding, and attachment loss.
During the first treatment session, patients were provided with information about periodontal disease, emphasizing the importance of controlling supragingival bacterial biofilms for successful treatment. Plaque-retentive factors (calculus) were removed. Temporary materials were used to restore carious lesions, root remnants were extracted, and maladaptive restorations were adjusted. Supragingival calculus was removed using periodontal scalers, followed by cleaning with a rubber cup, prophylaxis paste, dental floss, and/or interdental brushes. No prophylactic antibiotics were used prior to the
| Study group | Role | What they receive |
|---|---|---|
| Periodontal Health Intervention Group | Experimental | Participants in this arm will receive comprehensive periodontal health interventions, including:
1. Full periodontal evaluation using dental mirrors and probes (assessing visible plaque, probing depth, bleeding on probing, and attachment loss).
2. Supragingival scaling, root planing, and professional plaque removal.
3. Temporary restoration of carious lesions and extraction of root remnants, as needed.
4. Personalized oral hygiene instruction, including the use of multi-tufted brushes, toothpaste, floss, and interdental brushes. Receives: Procedure: Periodontal surgery |
| Standard Care Group | No intervention | Participants in this arm will receive standard care without specific periodontal interventions. This includes routine medical management for myocardial infarction, as per standard clinical guidelines, without structured periodontal treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in ejection fraction
The ejection fraction (EF) changed by 10% half a year after surgery
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (2)
Cardiovascular death and MACE events were recorded
Measured: From enrollment to the end of treatment at 6 months, a maximum of 12 months.
level of proBNP
The outcome will be assessed by measuring the level of plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP), a biomarker reflecting cardiac stress and heart failure.
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start1 Dec 2020
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial Infarction (AMI)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study employs a simulated randomized controlled trial (RCT) design to evaluate the effects of periodontal health interventions on patients with myocardial infarction (MI) complicated by periodontitis. The study mimics the framework of a traditional randomized controlled trial but does not involve formal randomization of participants. Participants are allocated into intervention and control groups in a structured manner to minimize bias, ensuring comparability.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745141
- Sponsor's protocol ID
- CCS-MIP-PHI
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Intervention Study in Patients with Myocardial Infarction and Periodontal Disease: a Simulated RCT Trial
- ClinicalTrials.gov ID
- NCT06745141
- Acronym / sponsor ID
- CCS-MIP-PHI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Dec 2024 (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.
The aim of this study is to establish a shared database of acute myocardial infarction patients with periodontitis, to clarify the clinical benefits of periodontitis intervention on acute myocardial infarction patients through simulated RCT study, and to establish a high-level database of acute myocardial infarction patients with periodontitis, so as to promote the application of oral health intervention in clinical practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study employs a simulated randomized controlled trial (RCT) design to evaluate the effects of periodontal health interventions on patients with myocardial infarction (MI) complicated by periodontitis. The study mimics the framework of a traditional randomized controlled trial but does not involve formal randomization of participants. Participants are allocated into intervention and control groups in a structured manner to minimize bias, ensuring comparability.
| Arm | Type | Receives |
|---|---|---|
| Periodontal Health Intervention Group | Experimental | Procedure: Periodontal surgeryParticipants in this arm will receive comprehensive periodontal health interventions, including: 1. Full periodontal evaluation using dental mirrors and probes (assessing visible plaque, probing depth, bleeding on probing, and attachment loss). 2. Supragingival scaling, root planing, and professional plaque removal. 3. Temporary restoration of carious lesions and extraction of root remnants, as needed. 4. Personalized oral hygiene instruction, including the use of multi-tufted brushes, toothpaste, floss, and interdental brushes. |
| Standard Care Group | No intervention | –Participants in this arm will receive standard care without specific periodontal interventions. This includes routine medical management for myocardial infarction, as per standard clinical guidelines, without structured periodontal treatment. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1)Patients diagnosed with ST-segment elevation myocardial infarction (STEMI). 2)Patients with severe periodontal disease, defined as:
Key exclusion criteria (1 listed)
- 1) under 30 years old; 2) HIV positive, chronic inflammation, tumor disease, drug dependence, use of anticonvulsants, use of immunosuppressive agents, pregnancy, and lactation; 3) significant tooth loss (number of remaining teeth < 8); 4) long hospital stay (>10 days), new myocardial infarction before randomization, and stent thrombosis; 5) Refusal to sign informed consent.
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 |
|---|---|---|
| Periodontal surgeryIn the intervention group, patients underwent a comprehensive periodontal evaluation conducted by periodontists at a dental clinic. All permanent teeth, except for third molars, were assessed using dental mirrors and periodontal probes. Each tooth was examined at four sites (vestibular, distal, lingual, and mesial) to evaluate visible plaque, probing depth, probing bleeding, and attachment loss. During the first treatment session, patients were provided with information about periodontal disease, emphasizing the importance of controlling supragingival bacterial biofilms for successful treatment. Plaque-retentive factors (calculus) were removed. Temporary materials were used to restore carious lesions, root remnants were extracted, and maladaptive restorations were adjusted. Supragingival calculus was removed using periodontal scalers, followed by cleaning with a rubber cup, prophylaxis paste, dental floss, and/or interdental brushes. No prophylactic antibiotics were used prior to the | Procedure or surgery | Periodontal Health Intervention Group |
Primary outcome
Changes in ejection fraction
Time frame: From enrollment to the end of treatment at 6 months
The ejection fraction (EF) changed by 10% half a year after surgery
2 secondary outcomes
Cardiovascular death and MACE events were recorded
Time frame: From enrollment to the end of treatment at 6 months, a maximum of 12 months.
level of proBNP
Time frame: From enrollment to the end of treatment at 6 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 20 Dec 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal surgery in people with Acute Myocardial Infarction (AMI) and Periodontal Disease, run by Shanghai 10th People's Hospital 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 1 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: looking for participants now, as of the sponsor's last update on 20 Dec 2024. 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?
Contact Jiawen Wu (86+17717070557, chloewuu@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in ejection fraction (time frame: From enrollment to the end of treatment at 6 months). 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 20 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.