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

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ClinicalTrials.gov Identifier: NCT03753451
Recruitment Status : Completed
First Posted : November 27, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
ANTONIO DE PADUA MANSUR, InCor Heart Institute

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.

Condition or disease Intervention/treatment Phase
Periodontal Diseases Procedure: treatment of periodontal disease Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Periodontal Disease Treatment on Serum Levels of Sirtuin 1 and Mannose-binding Lectin in Individuals With Coronary Artery Disease
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Group 1
20 patients without periodontal disease and coronary artery disease
No Intervention: Group 2
20 patients without periodontal disease and with coronary artery disease
Active Comparator: Group 3
20 patients with periodontal disease and with coronary artery disease received treatment of periodontal disease
Procedure: treatment of periodontal disease
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.

Active Comparator: Group 4
20 patients with periodontal disease and without coronary artery disease received treatment of periodontal disease
Procedure: treatment of periodontal disease
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.




Primary Outcome Measures :
  1. 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. ]
    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.

  2. After improving the periodontal clinical aspects, we observed whether there was an impact on serum levels of sirtuin-1 (SIRT1) protein. [ Time Frame: The periodontal treatment was performed and at the end of three-month period blood sample was collected. ]
    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.



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753451


Locations
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Brazil
INCOR- Heart Institute
Sao Paulo, São Paulo, Brazil, 05403900
INCOR - Heart Institute
São Paulo, Brazil, 05403-900
Sponsors and Collaborators
InCor Heart Institute
Investigators
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Principal Investigator: Antonio P Mansur, 1 Universidade de São Paulo, São Paulo, SP, BR
  Study Documents (Full-Text)

Documents provided by ANTONIO DE PADUA MANSUR, InCor Heart Institute:
Informed Consent Form  [PDF] October 6, 2016


Publications of Results:
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Responsible Party: ANTONIO DE PADUA MANSUR, Principal Investigator, InCor Heart Institute
ClinicalTrials.gov Identifier: NCT03753451     History of Changes
Other Study ID Numbers: SDC 4329/15/156
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ANTONIO DE PADUA MANSUR, InCor Heart Institute:
periodontal diseases
atherosclerosis
mannose binding protein
sirtuins
inflammation

Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases