NCT03753451

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 6, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
Last Updated

November 27, 2018

Status Verified

November 1, 2018

Enrollment Period

2 years

First QC Date

November 6, 2018

Last Update Submit

November 21, 2018

Conditions

Periodontal Diseases

Keywords

periodontal diseasesatherosclerosismannose binding proteinsirtuinsinflammation

Outcome Measures

Primary Outcomes (2)

  • 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.

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

  • 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.

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

Study Arms (4)

Group 1

NO INTERVENTION

20 patients without periodontal disease and coronary artery disease

Group 2

NO INTERVENTION

20 patients without periodontal disease and with coronary artery disease

Group 3

ACTIVE COMPARATOR

20 patients with periodontal disease and with coronary artery disease received treatment of periodontal disease

Procedure: treatment of periodontal disease

Group 4

ACTIVE COMPARATOR

20 patients with periodontal disease and without coronary artery disease received treatment of periodontal disease

Procedure: treatment of periodontal disease

Interventions

treatment of periodontal diseasePROCEDURE

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.

Group 3Group 4

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • uncontrolled diabetic,
  • dialytic,
  • smokers,
  • patients with HIV and Hepatitis B and C.
  • Pregnant subjects,
  • edentulous patients,
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

INCOR- Heart Institute

São Paulo, São Paulo, 05403900, Brazil

Location

INCOR - Heart Institute

São Paulo, 05403-900, Brazil

Location

Related Publications (5)

  • 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.

    PMID: 28029409RESULT

  • 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.

    PMID: 27624657RESULT

  • 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.

    PMID: 19252378RESULT

  • 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.

    PMID: 18823346RESULT

  • 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.

    PMID: 17785417RESULT

MeSH Terms

Conditions

Periodontal DiseasesAtherosclerosisInflammation

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Antonio P Mansur, 1

    Universidade de São Paulo, São Paulo, SP, BR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 6, 2018

First Posted

November 27, 2018

Study Start

October 1, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

November 27, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

BR(2)