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NCT Number: NCT03753451

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

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

INCOR- Heart Institute, São Paulo, Brazil

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

treatment of periodontal disease

Procedure

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

InCor Heart Institute

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 27, 2018
Registry last updated
Nov 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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