Coronary Heart DiseaseNCT04305171
Effect of Non-surgical Periodontal Treatment on Cardiovascular Risk Markers
An observational study of Coronary Heart Disease and Periodontitis, run by Mahidol University at 3 sites in Thailand.
Trial summary
The research question was to investigate whether non-surgical periodontal therapy could reduce cardiovascular risk markers in Coronary heart disease (CHD) patients. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease, Periodontitis
- What is being tested?
- non-surgical periodontal treatment
- Type of treatment
- Surgery or procedure
- How many people
- 28 participants
- Where
- 3 sitesThailand
- Study dates
- 6 Apr 2018to 20 Feb 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Outpatients who came to the Hospital for Tropical Medicine, Faculty of Tropical Medicine, Mahidol University or Rajavithi Hospital, Thailand
Who may be able to join
- non-CHD or CHD (at least 50% diameter stenosis in at least one coronary artery and clinically stable with absence of any potentially confounding inflammatory conditions for at least 6 months)
- had at least 14 natural teeth excluding third molars
Who cannot join
- received anticoagulant drugs
- had chronic conditions (e.g. diabetes mellitus, rheumatoid arthritis, malignancy, autoimmune disease) or acute conditions (e.g. trauma, surgery) or medications known to affect systemic inflammatory markers (e.g. antibiotics, immunosuppressive, contraceptives) within 3 months
- pregnancy or lactation
- presence or history of other infections
- periodontal treatment within 6 months
- tooth extractions within 2 months prior to the study.
Trial locations and contacts
3 sites in 1 country.
Thailand3 sites
Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University
Ratchathewi, Bangkok, 10400
Department of Medicine, Rajavithi Hospital
Ratchathewi, Bangkok, 10400
Mahidol University Faculty of Dentistry
Ratchathewi, Bangkok, 10400
About this study
Official title: Effect of Non-surgical Periodontal Treatment on Plasma Fibrinogen, Plasminogen Activator Inhibitor 1 and C-reactive Protein Levels in Cardiovascular Disease Patients With Periodontitis
The research question was to investigate whether non-surgical periodontal therapy could reduce cardiovascular risk markers in Coronary heart disease (CHD) patients.
Read the detailed description
CHD patients or non-CHD with or without periodontitis were included. They were provided with non-surgical periodontal therapy (NSPT). Periodontal parameters and cardiovascular risk markers were measured at baseline and 3 months and 6 months after NSPT.
- Conditions
- Coronary Heart Disease, Periodontitis
- Being tested
- non-surgical periodontal treatment
- Keywords
- Coronary heart disease, peridontitis,
- Medical subject headings
- Coronary Disease, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-surgical periodontal treatmentProcedure or surgery
scaling and root planing, home care instruction
| Study group | Role | What they receive |
|---|---|---|
| coronary heart disease patients with periodontitis | Coronary heart disease patients confirmed through coronary angiography as having at least 50% diameter stenosis in at least one coronary artery and clinically stable with the absence of any potentially confounding inflammatory conditions for at least 6 months.
Periodontitis classified as havingbleeding on probing (BOP), pocket depth (PD) > 4 mm, clinical attachment level (CAL) ≥ 5 mm and radiographic evidence of bone loss were presented at the same site of at least 4 teeth. Receives: Procedure: non-surgical periodontal treatment | |
| coronary heart disease patients without periodontitisHD | Coronary heart disease patients confirmed through coronary angiography as having at least 50% diameter stenosis in at least one coronary artery and clinically stable with the absence of any potentially confounding inflammatory conditions for at least 6 months.
Non-periodontitis classified as having PD ≤ 3 mm. Receives: Procedure: non-surgical periodontal treatment | |
| non-coronary heart disease patients with periodontitis | Periodontitis classified as havingbleeding on probing (BOP), pocket depth (PD) > 4 mm, clinical attachment level (CAL) ≥ 5 mm and radiographic evidence of bone loss were presented at the same site of at least 4 teeth. Receives: Procedure: non-surgical periodontal treatment | |
| non-coronary heart disease patients without periodontitis | Non-periodontitis classified as having PD ≤ 3 mm. Receives: Procedure: non-surgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in fibrinogen level between baseline and 3 months after non-surgical periodontal treatment
change in plasma fibrinogen level (pg/mL)
Measured: 3 months after non-surgical periodontal treatment
change in activator inhibitor 1 between baseline and 3 months after non-surgical periodontal treatment
change in activator inhibitor 1 level (pg/mL)
Measured: 3 months after non-surgical periodontal treatment
change in C-reactive protein between baseline and 3 months after non-surgical periodontal treatment
change in C-reactive protein level (mg/L)
Measured: 3 months after non-surgical periodontal treatment
change in fibrinogen level between baseline and 6 months after non-surgical periodontal treatment
change in plasma fibrinogen level (pg/mL)
Measured: 6 months after non-surgical periodontal treatment
change in activator inhibitor 1 between baseline and 6 months after non-surgical periodontal treatment
change in activator inhibitor 1 level (pg/mL)
Measured: 6 months after non-surgical periodontal treatment
change in C-reactive protein between baseline and 6 months after non-surgical periodontal treatment
change in C-reactive protein level (mg/L)
Measured: 6 months after non-surgical periodontal treatment
Secondary outcomes (6)
change of bleeding on probing between baseline and 3 months after non-surgical periodontal treatment
percetage of sites with bleeding on probing
Measured: 3 months after non-surgical periodontal treatment
change of pocket depth between baseline and 3 months after non-surgical periodontal treatment
Depth of periodontal pocket in millimeters
Measured: 3 months after non-surgical periodontal treatment
change of clinical attachment level between baseline and 3 months after non-surgical periodontal treatment
Level of clinical attachment in millimeters
Measured: 3 months after non-surgical periodontal treatment
change of bleeding on probing between baseline and 6 months after non-surgical periodontal treatment
percetage of sites with bleeding on probing
Measured: 6 months after non-surgical periodontal treatment
change of pocket depth between baseline and 6 months after non-surgical periodontal treatment
Depth of periodontal pocket in millimeters
Measured: 6 months after non-surgical periodontal treatment
change of clinical attachment level between baseline and 6 months after non-surgical periodontal treatment
Level of clinical attachment in millimeters
Measured: 6 months after non-surgical periodontal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start6 Apr 2018
- Primary completion31 Jan 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Supanee Rassameemasmaung, PhD, Principal investigator, Mahidol University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305171
- Sponsor's protocol ID
- MU-DT/PY-IRB 2018/022.0504
- Status last verified
- Mar 2020
- First submitted
- 27 Feb 2020
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ye Z, Cao Y, Miao C, Liu W, Dong L, Lv Z, Iheozor-Ejiofor Z, Li C. Periodontal therapy for primary or secondary prevention of cardiovascular disease in people with periodontitis. Cochrane Database Syst Rev. 2022 Oct 4;10(10):CD009197. doi: 10.1002/14651858.CD009197.pub5.
PubMed 36194420
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-surgical Periodontal Treatment on Plasma Fibrinogen, Plasminogen Activator Inhibitor 1 and C-reactive Protein Levels in Cardiovascular Disease Patients With Periodontitis
- ClinicalTrials.gov ID
- NCT04305171
- Acronym / sponsor ID
- MU-DT/PY-IRB 2018/022.0504
- Conditions
- Coronary Heart Disease, Periodontitis
- Keywords
- Coronary heart disease, peridontitis,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 12 Mar 2020 (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 research question was to investigate whether non-surgical periodontal therapy could reduce cardiovascular risk markers in Coronary heart disease (CHD) patients.
Detailed description
CHD patients or non-CHD with or without periodontitis were included. They were provided with non-surgical periodontal therapy (NSPT). Periodontal parameters and cardiovascular risk markers were measured at baseline and 3 months and 6 months after NSPT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| coronary heart disease patients with periodontitis | – | Procedure: non-surgical periodontal treatmentCoronary heart disease patients confirmed through coronary angiography as having at least 50% diameter stenosis in at least one coronary artery and clinically stable with the absence of any potentially confounding inflammatory conditions for at least 6 months. Periodontitis classified as havingbleeding on probing (BOP), pocket depth (PD) > 4 mm, clinical attachment level (CAL) ≥ 5 mm and radiographic evidence of bone loss were presented at the same site of at least 4 teeth. |
| coronary heart disease patients without periodontitisHD | – | Procedure: non-surgical periodontal treatmentCoronary heart disease patients confirmed through coronary angiography as having at least 50% diameter stenosis in at least one coronary artery and clinically stable with the absence of any potentially confounding inflammatory conditions for at least 6 months. Non-periodontitis classified as having PD ≤ 3 mm. |
| non-coronary heart disease patients with periodontitis | – | Procedure: non-surgical periodontal treatmentPeriodontitis classified as havingbleeding on probing (BOP), pocket depth (PD) > 4 mm, clinical attachment level (CAL) ≥ 5 mm and radiographic evidence of bone loss were presented at the same site of at least 4 teeth. |
| non-coronary heart disease patients without periodontitis | – | Procedure: non-surgical periodontal treatmentNon-periodontitis classified as having PD ≤ 3 mm. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients who came to the Hospital for Tropical Medicine, Faculty of Tropical Medicine, Mahidol University or Rajavithi Hospital, Thailand
Key inclusion criteria (2 listed)
- non-CHD or CHD (at least 50% diameter stenosis in at least one coronary artery and clinically stable with absence of any potentially confounding inflammatory conditions for at least 6 months)
- had at least 14 natural teeth excluding third molars
Key exclusion criteria (6 listed)
- received anticoagulant drugs
- had chronic conditions (e.g. diabetes mellitus, rheumatoid arthritis, malignancy, autoimmune disease) or acute conditions (e.g. trauma, surgery) or medications known to affect systemic inflammatory markers (e.g. antibiotics, immunosuppressive, contraceptives) within 3 months
- pregnancy or lactation
- presence or history of other infections
- periodontal treatment within 6 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 treatmentscaling and root planing, home care instruction | Procedure or surgery | coronary heart disease patients with periodontitis, coronary heart disease patients without periodontitisHD, non-coronary heart disease patients with periodontitis, non-coronary heart disease patients without periodontitis |
Primary outcome
change in fibrinogen level between baseline and 3 months after non-surgical periodontal treatment
Time frame: 3 months after non-surgical periodontal treatment
change in plasma fibrinogen level (pg/mL)
change in activator inhibitor 1 between baseline and 3 months after non-surgical periodontal treatment
Time frame: 3 months after non-surgical periodontal treatment
change in activator inhibitor 1 level (pg/mL)
change in C-reactive protein between baseline and 3 months after non-surgical periodontal treatment
Time frame: 3 months after non-surgical periodontal treatment
change in C-reactive protein level (mg/L)
change in fibrinogen level between baseline and 6 months after non-surgical periodontal treatment
Time frame: 6 months after non-surgical periodontal treatment
change in plasma fibrinogen level (pg/mL)
change in activator inhibitor 1 between baseline and 6 months after non-surgical periodontal treatment
Time frame: 6 months after non-surgical periodontal treatment
change in activator inhibitor 1 level (pg/mL)
change in C-reactive protein between baseline and 6 months after non-surgical periodontal treatment
Time frame: 6 months after non-surgical periodontal treatment
change in C-reactive protein level (mg/L)
6 secondary outcomes
change of bleeding on probing between baseline and 3 months after non-surgical periodontal treatment
Time frame: 3 months after non-surgical periodontal treatment
change of pocket depth between baseline and 3 months after non-surgical periodontal treatment
Time frame: 3 months after non-surgical periodontal treatment
change of clinical attachment level between baseline and 3 months after non-surgical periodontal treatment
Time frame: 3 months after non-surgical periodontal treatment
change of bleeding on probing between baseline and 6 months after non-surgical periodontal treatment
Time frame: 6 months after non-surgical periodontal treatment
change of pocket depth between baseline and 6 months after non-surgical periodontal treatment
Time frame: 6 months after non-surgical periodontal treatment
change of clinical attachment level between baseline and 6 months after non-surgical periodontal treatment
Time frame: 6 months after non-surgical periodontal treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Derived from this study: PubMed 36194420Ye Z, Cao Y, Miao C, Liu W, Dong L, Lv Z, Iheozor-Ejiofor Z, Li C. Periodontal therapy for primary or secondary prevention of cardiovascular disease in people with periodontitis. Cochrane Database Syst Rev. 2022 Oct 4;10(10):CD009197. doi: 10.1002/14651858.CD009197.pub5.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Supanee Rassameemasmaung, PhD principal investigator
Mahidol University Faculty of Dentistry
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease and Periodontitis, run by Mahidol University at 3 sites in Thailand.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change in fibrinogen level between baseline and 3 months after non-surgical periodontal treatment (time frame: 3 months after non-surgical periodontal treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04305171, which also lists 1 linked publication.
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 12 Mar 2020.