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Periodontal DiseasesNCT03753451

Influence of Periodontal Disease Treatment on Serum Levels of Sirtuin 1 and Mannose-binding Lectin

A study testing treatment of periodontal disease in people with Periodontal Diseases, run by InCor Heart Institute at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The premise of the relationship between the atherosclerotic process of coronary artery disease and periodontal disease is the immunoinflammatory process, which causes a significant increase in serum concentration of mannose-binding lectin. Read more about this study

Who is it for?
Ages 45 years and olderHealthy volunteers can take part
Conditions the study is for
Periodontal Diseases
What is being tested?
treatment of periodontal disease
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesBrazil
Study dates
1 Oct 2016to 1 Oct 2018
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 45 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Presence of installed periodontal disease.
  • More than 15 teeth in the mouth

Who cannot join

  • uncontrolled diabetic,
  • dialytic,
  • smokers,
  • patients with HIV and Hepatitis B and C.
  • Pregnant subjects,
  • edentulous patients,
Show all 9Show fewer
  • orthodontic brachytherapy were excluded from the study,
  • patients using specific drugs known to affect periodontal tissues,
  • patients who have undergone previous periodontal treatment (minimum of 6 months), * patients taking anti-inflammatory drugs and corticosteroids.

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • INCOR- Heart Institute

    São Paulo, São Paulo, 05403900

  • INCOR - Heart Institute

    São Paulo, 05403-900

Other trials in Brazil

About this study

Official title: Influence of Periodontal Disease Treatment on Serum Levels of Sirtuin 1 and Mannose-binding Lectin in Individuals With Coronary Artery Disease

The premise of the relationship between the atherosclerotic process of coronary artery disease and periodontal disease is the immunoinflammatory process, which causes a significant increase in serum concentration of mannose-binding lectin. This protein is part of the innate immunity and has the ability to bind to the mannose residues common to various pathogens. Animal studies also showed that increased serum concentration of sirtuin-1 was associated with reduced inflammation. Evidence indicates that sirtuin-1 plays an important role in vascular protection and is associated with aging. OBJECTIVES: This study examined the influence of non-surgical treatment of periodontal disease on the serum concentration of mannose-binding lectin and sirtuin-1 in patients with periodontal disease and coronary artery disease. METHODS: Seventy-eight patients, 38 women and 40 men, mean age 58 ± 8 years old, were divided into 4 groups: 20 healthy subjects (group 1), 18 patients with coronary artery disease and without periodontal disease (group 2), 20 patients with periodontal disease and without coronary artery disease (group 3) and 20 patients with coronary artery disease and periodontal disease (group 4). Peripheral blood samples were collected at the beginning and at the end of the treatment of periodontal disease.

Read the detailed description

Inclusion criteria for PD were: presence of at least 15 teeth and clinical diagnosis of PD. Excluding third molars. This diagnosis was confirmed by the presence of at least 6 teeth with at least one noncontiguous interproximal site with Probing Pocket Depth (PPD) and Clinical Attachment Loss (CAL) ≥ 5 mm, as well as 30% of Sites with PPD and CAL ≥ 4mm and bleeding on Probing (BOP). Periodontal disease currently classified as Stage III Degree B. Periodontal healthy was defined as individuals who presented a periodontium without loss of insertion, with PPD ≤3 mm, BOP in less than 10% of the sites and without radiographic bone loss.

Non-surgical periodontal treatment was performed, including oral hygiene education, scaling, smoothing and coronal-radicular polishing (RAR). Six sites were evaluated in each tooth (mesiobuccal, buccal, distobuccal, distolingual/palatal, lingual/palatal and mesiolingual/palatal surfaces). Scaling and root planing were performed using mechanical devices - ultrasound and manual instruments. The treatment was with local anesthesia, 3% lidocaine with vasoconstrictor, for PPD ≥ 5 mm. The objective of each session was to achieve a smooth surface, devoid of biofilm and calculus.

The following parameters are evaluated during clinical examination: Probing Pocket Depth (PPD), distance of the enamel-cementum line at the gingival margin, clinical Attachment Loss (CAL), plaque index (IP) and bleeding on probing (BOP), PPD and CAL measurements are rounded to the nearest millimeter using a North Carolina periodontal probe (Chicago, USA).

Being tested
treatment of periodontal disease
Keywords
periodontal diseases, atherosclerosis, mannose binding protein, sirtuins, inflammation
Medical subject headings
Periodontal Diseases, Atherosclerosis, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • treatment of periodontal diseaseProcedure or surgery

    Patients with periodontal disease received treatment of periodontal disease through ultrasound or manual scaling of dental calculations. In addition to receiving instructions to improve oral health, such as the correct use of dental floss, adequate time and the correct way to brush.

Study groups in NCT03753451
Study groupRoleWhat they receive
Group 1No intervention20 patients without periodontal disease and coronary artery disease
Group 2No intervention20 patients without periodontal disease and with coronary artery disease
Group 3Active comparator20 patients with periodontal disease and with coronary artery disease received treatment of periodontal disease
Receives: Procedure: treatment of periodontal disease
Group 4Active comparator20 patients with periodontal disease and without coronary artery disease received treatment of periodontal disease
Receives: Procedure: treatment of periodontal disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. After improving the periodontal clinical aspects, we observed whether there was an impact on serum levels of mannose-binding lectin (MBL) protein.

    Non-surgical periodontal treatment was performed to treat the periodontal disease and it included oral hygiene education, scaling, smoothing and polishing of the root and dental crown (RAR). Blood sample was collected at baseline and at the end of study.

    Measured: The periodontal treatment was performed and at the end of three-month period blood sample was collected.

  2. After improving the periodontal clinical aspects, we observed whether there was an impact on serum levels of sirtuin-1 (SIRT1) protein.

    Non-surgical periodontal treatment was performed to treat the periodontal disease and it included oral hygiene education, scaling, smoothing and polishing of the root and dental crown (RAR). Blood sample was collected at baseline and at the end of study.

    Measured: The periodontal treatment was performed and at the end of three-month period blood sample was collected.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2018
  2. Study start1 Oct 2016
  3. Primary completion1 Oct 2018
  4. Study completion1 Oct 2018

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03753451
Sponsor's protocol ID
SDC 4329/15/156
Status last verified
Nov 2018
First submitted
6 Nov 2018
Last updated
27 Nov 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mansur AP, Roggerio A, Goes MFS, Avakian SD, Leal DP, Maranhao RC, Strunz CMC. Serum concentrations and gene expression of sirtuin 1 in healthy and slightly overweight subjects after caloric restriction or resveratrol supplementation: A randomized trial. Int J Cardiol. 2017 Jan 15;227:788-794. doi: 10.1016/j.ijcard.2016.10.058. Epub 2016 Oct 27.

    PubMed 28029409

  • Liukkonen A, He Q, Gursoy UK, Pussinen PJ, Grondahl-Yli-Hannuksela K, Liukkonen J, Sorsa T, Suominen AL, Huumonen S, Kononen E. Mannose-binding lectin gene polymorphism in relation to periodontal infection. J Periodontal Res. 2017 Jun;52(3):540-545. doi: 10.1111/jre.12420. Epub 2016 Sep 14.

    PubMed 27624657

  • Tsutsumi A, Kobayashi T, Ito S, Goto D, Matsumoto I, Yoshie H, Sumida T. Mannose binding lectin gene polymorphism and the severity of chronic periodontitis. Nihon Rinsho Meneki Gakkai Kaishi. 2009 Feb;32(1):48-52. doi: 10.2177/jsci.32.48.

    PubMed 19252378

  • Louropoulou A, van der Velden U, Schoenmaker T, Catsburg A, Savelkoul PH, Loos BG. Mannose-binding lectin gene polymorphisms in relation to periodontitis. J Clin Periodontol. 2008 Nov;35(11):923-30. doi: 10.1111/j.1600-051X.2008.01311.x. Epub 2008 Sep 20.

    PubMed 18823346

  • Mattagajasingh I, Kim CS, Naqvi A, Yamamori T, Hoffman TA, Jung SB, DeRicco J, Kasuno K, Irani K. SIRT1 promotes endothelium-dependent vascular relaxation by activating endothelial nitric oxide synthase. Proc Natl Acad Sci U S A. 2007 Sep 11;104(37):14855-60. doi: 10.1073/pnas.0704329104. Epub 2007 Sep 4.

    PubMed 17785417

Questions about this trial

What is this clinical trial studying?

A study testing treatment of periodontal disease in people with Periodontal Diseases, run by InCor Heart Institute at 2 sites in Brazil.

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 9 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 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. 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?

After improving the periodontal clinical aspects, we observed whether there was an impact on serum levels of mannose-binding lectin (MBL) protein. (time frame: The periodontal treatment was performed and at the end of three-month period blood sample was collected.). The study lists 2 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 NCT03753451, which also lists 5 linked publications.

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 27 Nov 2018.

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