NCT02543502

Brief Summary

The main objective of this study is to evaluate the effect of treatment periodontal endothelium-dependent artery of the arm in patients with acute myocardial infarction with ST-segment elevation undergoing primary coronary intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

August 1, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
Last Updated

September 7, 2015

Status Verified

September 1, 2015

Enrollment Period

2.4 years

First QC Date

August 27, 2015

Last Update Submit

September 4, 2015

Conditions

Keywords

PeriodontitisatherosclerosisHeart Disease

Outcome Measures

Primary Outcomes (1)

  • The difference in dilation measured by brachial artery blood flow

    The primary outcome will be the difference in the dilation measured through the flow in the brachial artery by the end of six months.

    6 months

Secondary Outcomes (1)

  • Major cardiovascular events

    6 months

Other Outcomes (1)

  • Bacteremia

    24 hours

Study Arms (2)

periodontal treatment

EXPERIMENTAL

Group will receive treatment: periodontal treatment

Procedure: periodontal treatment

Control Group.

NO INTERVENTION

Group will not receive treatment: periodontal treatment

Interventions

treatment of periodontal cleaning

periodontal treatment

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients admitted to our institution with a diagnosis of AMI (ST segment elevation\> 0.1mV)
  • older than 30 years
  • with more than 8 teeth in the mouth
  • with advanced periodontal disease

You may not qualify if:

  • acute or chronical infection
  • impossibility of attending the following interviews and/or the periodontal treatment
  • refusing to signing the consent form
  • individuals with substance abuse
  • anticonvulsants and immunosuppressant drugs users
  • pregnant and \\ or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Cardiologia do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Publications (29)

  • Schmidt MI, Duncan BB, Azevedo e Silva G, Menezes AM, Monteiro CA, Barreto SM, Chor D, Menezes PR. Chronic non-communicable diseases in Brazil: burden and current challenges. Lancet. 2011 Jun 4;377(9781):1949-61. doi: 10.1016/S0140-6736(11)60135-9. Epub 2011 May 9.

    PMID: 21561658BACKGROUND
  • Bahekar AA, Singh S, Saha S, Molnar J, Arora R. The prevalence and incidence of coronary heart disease is significantly increased in periodontitis: a meta-analysis. Am Heart J. 2007 Nov;154(5):830-7. doi: 10.1016/j.ahj.2007.06.037. Epub 2007 Aug 20.

    PMID: 17967586BACKGROUND
  • D'Aiuto F, Parkar M, Tonetti MS. Acute effects of periodontal therapy on bio-markers of vascular health. J Clin Periodontol. 2007 Feb;34(2):124-9. doi: 10.1111/j.1600-051X.2006.01037.x. Epub 2007 Jan 3.

    PMID: 17214734BACKGROUND
  • Humphrey LL, Fu R, Buckley DI, Freeman M, Helfand M. Periodontal disease and coronary heart disease incidence: a systematic review and meta-analysis. J Gen Intern Med. 2008 Dec;23(12):2079-86. doi: 10.1007/s11606-008-0787-6. Epub 2008 Sep 20.

    PMID: 18807098BACKGROUND
  • Libby P, Ridker PM, Hansson GK; Leducq Transatlantic Network on Atherothrombosis. Inflammation in atherosclerosis: from pathophysiology to practice. J Am Coll Cardiol. 2009 Dec 1;54(23):2129-38. doi: 10.1016/j.jacc.2009.09.009.

    PMID: 19942084BACKGROUND
  • Lockhart PB, Bolger AF, Papapanou PN, Osinbowale O, Trevisan M, Levison ME, Taubert KA, Newburger JW, Gornik HL, Gewitz MH, Wilson WR, Smith SC Jr, Baddour LM; American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee of the Council on Cardiovascular Disease in the Young, Council on Epidemiology and Prevention, Council on Peripheral Vascular Disease, and Council on Clinical Cardiology. Periodontal disease and atherosclerotic vascular disease: does the evidence support an independent association?: a scientific statement from the American Heart Association. Circulation. 2012 May 22;125(20):2520-44. doi: 10.1161/CIR.0b013e31825719f3. Epub 2012 Apr 18.

    PMID: 22514251BACKGROUND
  • Ridker PM. C-reactive protein, inflammation, and cardiovascular disease: clinical update. Tex Heart Inst J. 2005;32(3):384-6. No abstract available.

    PMID: 16392225BACKGROUND
  • Tonetti MS, D'Aiuto F, Nibali L, Donald A, Storry C, Parkar M, Suvan J, Hingorani AD, Vallance P, Deanfield J. Treatment of periodontitis and endothelial function. N Engl J Med. 2007 Mar 1;356(9):911-20. doi: 10.1056/NEJMoa063186.

    PMID: 17329698BACKGROUND
  • Yu YH, Chasman DI, Buring JE, Rose L, Ridker PM. Cardiovascular risks associated with incident and prevalent periodontal disease. J Clin Periodontol. 2015 Jan;42(1):21-8. doi: 10.1111/jcpe.12335. Epub 2015 Jan 9.

    PMID: 25385537BACKGROUND
  • Albandar JM, Brunelle JA, Kingman A. Destructive periodontal disease in adults 30 years of age and older in the United States, 1988-1994. J Periodontol. 1999 Jan;70(1):13-29. doi: 10.1902/jop.1999.70.1.13.

    PMID: 10052767BACKGROUND
  • Castro GD, Oppermann RV, Haas AN, Winter R, Alchieri JC. Association between psychosocial factors and periodontitis: a case-control study. J Clin Periodontol. 2006 Feb;33(2):109-14. doi: 10.1111/j.1600-051X.2005.00878.x.

    PMID: 16441734BACKGROUND
  • D'Aiuto F, Parkar M, Andreou G, Suvan J, Brett PM, Ready D, Tonetti MS. Periodontitis and systemic inflammation: control of the local infection is associated with a reduction in serum inflammatory markers. J Dent Res. 2004 Feb;83(2):156-60. doi: 10.1177/154405910408300214.

    PMID: 14742655BACKGROUND
  • D'Aiuto F, Parkar M, Tonetti MS. Periodontal therapy: a novel acute inflammatory model. Inflamm Res. 2005 Oct;54(10):412-4. doi: 10.1007/s00011-005-1375-4.

    PMID: 16283108BACKGROUND
  • Elter JR, Hinderliter AL, Offenbacher S, Beck JD, Caughey M, Brodala N, Madianos PN. The effects of periodontal therapy on vascular endothelial function: a pilot trial. Am Heart J. 2006 Jan;151(1):47. doi: 10.1016/j.ahj.2005.10.002.

    PMID: 16368290BACKGROUND
  • Joshipura KJ, Wand HC, Merchant AT, Rimm EB. Periodontal disease and biomarkers related to cardiovascular disease. J Dent Res. 2004 Feb;83(2):151-5. doi: 10.1177/154405910408300213.

    PMID: 14742654BACKGROUND
  • Libby P, Okamoto Y, Rocha VZ, Folco E. Inflammation in atherosclerosis: transition from theory to practice. Circ J. 2010 Feb;74(2):213-20. doi: 10.1253/circj.cj-09-0706. Epub 2010 Jan 9.

    PMID: 20065609BACKGROUND
  • Pussinen PJ, Tuomisto K, Jousilahti P, Havulinna AS, Sundvall J, Salomaa V. Endotoxemia, immune response to periodontal pathogens, and systemic inflammation associate with incident cardiovascular disease events. Arterioscler Thromb Vasc Biol. 2007 Jun;27(6):1433-9. doi: 10.1161/ATVBAHA.106.138743. Epub 2007 Mar 15.

    PMID: 17363692BACKGROUND
  • Ramirez JH, Arce RM, Contreras A. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial. Trials. 2011 Feb 16;12:46. doi: 10.1186/1745-6215-12-46.

    PMID: 21324167BACKGROUND
  • Teeuw WJ, Slot DE, Susanto H, Gerdes VE, Abbas F, D'Aiuto F, Kastelein JJ, Loos BG. Treatment of periodontitis improves the atherosclerotic profile: a systematic review and meta-analysis. J Clin Periodontol. 2014 Jan;41(1):70-9. doi: 10.1111/jcpe.12171. Epub 2013 Oct 29.

    PMID: 24111886BACKGROUND
  • Blum A, Front E, Peleg A. Periodontal care may improve systemic inflammation. Clin Invest Med. 2007;30(3):E114-7. doi: 10.25011/cim.v30i3.1079.

    PMID: 17716549BACKGROUND
  • Pischon N, Hagewald S, Kunze M, Heng N, Christan C, Kleber BM, Muller C, Bernimoulin JP. Influence of periodontal therapy on the regulation of soluble cell adhesion molecule expression in aggressive periodontitis patients. J Periodontol. 2007 Apr;78(4):683-90. doi: 10.1902/jop.2007.060286.

    PMID: 17397316BACKGROUND
  • Li X, Tse HF, Jin LJ. Novel endothelial biomarkers: implications for periodontal disease and CVD. J Dent Res. 2011 Sep;90(9):1062-9. doi: 10.1177/0022034510397194. Epub 2011 Feb 14.

    PMID: 21321068BACKGROUND
  • Li X, Tse HF, Yiu KH, Li LS, Jin L. Effect of periodontal treatment on circulating CD34(+) cells and peripheral vascular endothelial function: a randomized controlled trial. J Clin Periodontol. 2011 Feb;38(2):148-56. doi: 10.1111/j.1600-051X.2010.01651.x. Epub 2010 Dec 6.

    PMID: 21133981BACKGROUND
  • Piconi S, Trabattoni D, Luraghi C, Perilli E, Borelli M, Pacei M, Rizzardini G, Lattuada A, Bray DH, Catalano M, Sparaco A, Clerici M. Treatment of periodontal disease results in improvements in endothelial dysfunction and reduction of the carotid intima-media thickness. FASEB J. 2009 Apr;23(4):1196-204. doi: 10.1096/fj.08-119578. Epub 2008 Dec 12.

    PMID: 19074511BACKGROUND
  • Amar S, Gokce N, Morgan S, Loukideli M, Van Dyke TE, Vita JA. Periodontal disease is associated with brachial artery endothelial dysfunction and systemic inflammation. Arterioscler Thromb Vasc Biol. 2003 Jul 1;23(7):1245-9. doi: 10.1161/01.ATV.0000078603.90302.4A. Epub 2003 May 22.

    PMID: 12763762BACKGROUND
  • Mercanoglu F, Oflaz H, Oz O, Gokbuget AY, Genchellac H, Sezer M, Nisanci Y, Umman S. Endothelial dysfunction in patients with chronic periodontitis and its improvement after initial periodontal therapy. J Periodontol. 2004 Dec;75(12):1694-700. doi: 10.1902/jop.2004.75.12.1694.

    PMID: 15732873BACKGROUND
  • Saffi MA, Furtado MV, Polanczyk CA, Montenegro MM, Ribeiro IW, Kampits C, Haas AN, Rosing CK, Rabelo-Silva ER. Relationship between vascular endothelium and periodontal disease in atherosclerotic lesions: Review article. World J Cardiol. 2015 Jan 26;7(1):26-30. doi: 10.4330/wjc.v7.i1.26.

    PMID: 25632316BACKGROUND
  • Seinost G, Wimmer G, Skerget M, Thaller E, Brodmann M, Gasser R, Bratschko RO, Pilger E. Periodontal treatment improves endothelial dysfunction in patients with severe periodontitis. Am Heart J. 2005 Jun;149(6):1050-4. doi: 10.1016/j.ahj.2004.09.059.

    PMID: 15976787BACKGROUND
  • Lobo MG, Schmidt MM, Lopes RD, Dipp T, Feijo IP, Schmidt KES, Gazeta CA, Azeredo ML, Markoski M, Pellanda LC, Gottschall CAM, Quadros AS. Treating periodontal disease in patients with myocardial infarction: A randomized clinical trial. Eur J Intern Med. 2020 Jan;71:76-80. doi: 10.1016/j.ejim.2019.08.012. Epub 2019 Dec 4.

MeSH Terms

Conditions

PeriodontitisAtherosclerosisHeart Diseases

Interventions

Periodontal Index

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dental Health SurveysHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDentistryPeriodonticsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Dentistry

Study Officials

  • Alexandre Sc Quadros, Phd

    Instituto de Cardiologia do Rio Grande do Sul, IC-FUC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2015

First Posted

September 7, 2015

Study Start

August 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

September 7, 2015

Record last verified: 2015-09

Locations