Cardiovascular Risk MarkersNCT04540328
Non-surgical Peridontal Treatment on Cardiovascular Risk Markers
A study testing Non-surgical periodontal treatment in people with Cardiovascular Risk Markers and Chronic Periodontitis, run by Kırıkkale University.
Trial summary
The study evaluates the influence of non-surgical mechanical periodontal treatment in patients with severe chronic periodontitis on inflammatory markers related to risk for cardiovascular diseases Read more about this study
- Who is it for?
- Ages 30 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Markers, Chronic Periodontitis
- What is being tested?
- Non-surgical periodontal treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Aug 2017
- Phase
- Interventional
- 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 30 to 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosis of severe chronic periodontitis
- Clinical diagnosis of periodontal health
Who cannot join
- Systemic diseases such as diabetes, cardiovascular disease
- Periodontal treatment within the previous year
- Drugs such as systemic steroids, non-steroidal anti-inflammatory drugs, immunosuppressants, hormone drugs, contraceptives, anticoagulants, cholesterol regulating drugs, systemic antibiotics, antioxidants within the previous 3 months
- Pregnant or lactating
- Consumed alcohol
- Smoker
About this study
Official title: Effect of Non-surgical Peridontal Treatment on Cardiovascular Risk Markers in Patients With Severe Chronic Periodontitis
The study evaluates the influence of non-surgical mechanical periodontal treatment in patients with severe chronic periodontitis on inflammatory markers related to risk for cardiovascular diseases
Read the detailed description
A total of 80 non-smokers with systemically healthy, including 40 patients with severe chronic periodontitis and 40 periodontally health subjects were included into the present study. The probing depth, clinical attachment level, plaque index, gingival index and blood samples were collected at baseline and at the 3rd months after treatment and the serum levels of asymmetric dimethylarginine (ADMA), endothelial nitric oxide synthase (eNOS), homocysteine (Hcy), monocyte chemoattractant protein-1 (MCP-1) were determined with enzyme-linked immunosorbent assay (ELISA).
- Conditions
- Cardiovascular Risk Markers, Chronic Periodontitis
- Being tested
- Non-surgical periodontal treatment
- Keywords
- asymmetric dimethylarginine, endothelial nitric oxide synthase, homocysteine, monocyte chemoattractant protein-1
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal treatmentOther
| Study group | Role | What they receive |
|---|---|---|
| Non-surgical peridontal treatment | Other | Patients with chronic periodontitis received non-surgical periodontal treatment, including scaling and root planing and polishing within 14 days under local anesthesia with manual and ultrasonic devices and standardized oral hygiene instructions including methods of tooth-brushing and interdental cleaning were also given to each one. A professional supragingival plaque control was applied on a regular basis every month. Receives: Other: Non-surgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asymmetric dimethylarginine (ADMA)
Serum Concentration (pg/mL)
Measured: At the 3rd months after non-surgical periodontal treatment
Endothelial nitric oxide synthase (eNOS)
Serum Concentration (pg/mL)
Measured: At the 3rd months after non-surgical periodontal treatment
Homocysteine (Hcy)
Serum Concentration (nmol/mL)
Measured: At the 3rd months after non-surgical periodontal treatment
Monocyte chemoattractant protein-1 (MCP-1)
Serum Concentration (ng/mL)
Measured: At the 3rd months after non-surgical periodontal treatment
Secondary outcomes (1)
Clinical periodontal parameter
Clinical attachment level (mm)
Measured: At the 3rd 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 posted7 Sep 2020
- Study startAug 2015
- Primary completionFeb 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk MarkersStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Karsiyaka Hendek, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540328
- Sponsor's protocol ID
- 2015 / 029
- Status last verified
- Sep 2020
- First submitted
- 7 Mar 2018
- Last updated
- 7 Sep 2020
- 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 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-surgical Peridontal Treatment on Cardiovascular Risk Markers in Patients With Severe Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT04540328
- Acronym / sponsor ID
- 2015 / 029
- Conditions
- Cardiovascular Risk Markers, Chronic Periodontitis
- Keywords
- asymmetric dimethylarginine, endothelial nitric oxide synthase, homocysteine, monocyte chemoattractant protein-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 7 Sep 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 study evaluates the influence of non-surgical mechanical periodontal treatment in patients with severe chronic periodontitis on inflammatory markers related to risk for cardiovascular diseases
Detailed description
A total of 80 non-smokers with systemically healthy, including 40 patients with severe chronic periodontitis and 40 periodontally health subjects were included into the present study. The probing depth, clinical attachment level, plaque index, gingival index and blood samples were collected at baseline and at the 3rd months after treatment and the serum levels of asymmetric dimethylarginine (ADMA), endothelial nitric oxide synthase (eNOS), homocysteine (Hcy), monocyte chemoattractant protein-1 (MCP-1) were determined with enzyme-linked immunosorbent assay (ELISA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-surgical peridontal treatment | Other | Other: Non-surgical periodontal treatmentPatients with chronic periodontitis received non-surgical periodontal treatment, including scaling and root planing and polishing within 14 days under local anesthesia with manual and ultrasonic devices and standardized oral hygiene instructions including methods of tooth-brushing and interdental cleaning were also given to each one. A professional supragingival plaque control was applied on a regular basis every month. |
Who may qualify
- Ages
- 30 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of severe chronic periodontitis
- Clinical diagnosis of periodontal health
Key exclusion criteria (6 listed)
- Systemic diseases such as diabetes, cardiovascular disease
- Periodontal treatment within the previous year
- Drugs such as systemic steroids, non-steroidal anti-inflammatory drugs, immunosuppressants, hormone drugs, contraceptives, anticoagulants, cholesterol regulating drugs, systemic antibiotics, antioxidants within the previous 3 months
- Pregnant or lactating
- Consumed alcohol
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 treatment | Other | Non-surgical peridontal treatment |
Primary outcome
Asymmetric dimethylarginine (ADMA)
Time frame: At the 3rd months after non-surgical periodontal treatment
Serum Concentration (pg/mL)
Endothelial nitric oxide synthase (eNOS)
Time frame: At the 3rd months after non-surgical periodontal treatment
Serum Concentration (pg/mL)
Homocysteine (Hcy)
Time frame: At the 3rd months after non-surgical periodontal treatment
Serum Concentration (nmol/mL)
Monocyte chemoattractant protein-1 (MCP-1)
Time frame: At the 3rd months after non-surgical periodontal treatment
Serum Concentration (ng/mL)
1 secondary outcome
Clinical periodontal parameter
Time frame: At the 3rd 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 7 Sep 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Non-surgical periodontal treatment in people with Cardiovascular Risk Markers and Chronic Periodontitis, run by Kırıkkale University.
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 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Asymmetric dimethylarginine (ADMA) (time frame: At the 3rd months after non-surgical periodontal treatment). The study lists 4 primary outcomes in all. 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 7 Sep 2020.