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Completed

NCT Number: NCT03146975

Effects of Gum Disease Treatment on Host Defense Factors

Human immune system produces many different factors, which will influence health-disease statuses. This partially explains why under similar conditions only some people become sick. Therefore, specific analyses of such factors in healthy and diseased patients are crucial for a better knowledge about diseases development and successful treatments. Human beta defensins (hBD) may have a key role in patient's susceptibility to gum diseases. In the lab, high levels of sugar (glucose) could inhibit their expression and contribute to the occurrence of infections associated with diabetic wounds. This study will evaluate if treatment of the most common gum disease in adults influences production of beta defensins by gingiva. Also, clinical improvements and treatment effects on blood glycemic levels will be monitored throughout a 2-month period. Patients with or without gum diseases and with or without diabetes mellitus will be able to participate. After a complete oral examination to determine periodontal status, gingival fluid samples will be collected using paper strips. These samples will be collected before and also two-months after oral treatment and will be analyzed by an immune-enzymatic test named ELISA (Enzyme-Linked Immunosorbent Assay). In weekly sections, one trained specialist will performed treatment of gum diseases under local anesthesia using hand-instruments. Researchers hypothesized that a) levels of defensins would be lower in the presence of periodontal disease when compared to a healthy periodontal condition; b) diabetes would influence production of these immune protective factors; and c) treatment would provide a greater beneficial amount of defensins.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal university of minas gerais

Belo Horizonte, Minas Gerais, Brazil

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Periodontally healthy individuals: at least 15 natural teeth, periodontal pocket depth (PPD) ≤ 3mm e absence of bleeding on probing.
  • Periodontitis individuals: at least 15 natural teeth and at least 4 teeth with one or more periodontal sites showing combined PPD ≥ 4mm and clinical attachment level (CAL) ≥ 3mm.
  • Compensated diabetic individuals: compensated type 2 diabetes mellitus
  • Decompensated diabetic individuals: decompensated type 2 diabetes mellitus (glycated hemoglobin HbA1c >7%)

Exclusion criteria

  • Past or actual systemic diseases other than diabetes type 2 in the diabetic groups
  • Gingivitis
  • Gingival overgrowth
  • Necrotizing periodontal diseases
  • Pregnant or lactating
  • smokers or former-smokers
  • medication that can influence periodontal status or host response to periodontal therapy
  • periodontal therapy in the past 6 months from baseline
  • use of systemic or local antibiotics or anti-inflammatory drugs within 3 months prior baseline

Treatment and study plan

Non-surgical periodontal treatment

Procedure

Quadrant-wise ultrasonic debridement followed by manual scaling and root planing under local anesthesia provided in weekly sections. Oral hygiene instructions.

Primary outcomes

  1. Changes in beta defensins 1, 2 and 3

    Time frame: Baseline and 60 days

    Increase in the expression of beta defensins 1, 2 and 3 in gingival crevicular fluid samples

Secondary outcomes

  1. Changes in periodontal pocket depth

    Time frame: Baseline and 60 days

    Reduction in mean periodontal pocket depth

  2. Changes in blood glycemic levels

    Time frame: Baseline and 60 days

    Reduction in blood glucose levels and levels of glycated hemoglobin

  3. Changes in percentage of diseased sites

    Time frame: Baseline and 60 days

    Reduction in the percentage of sites showing PPD>4mm and/or bleeding on probing

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

Effects of Non-surgical Periodontal Treatment on Gingival Beta Defensins in Different Clinical Conditions : a Short-term Clinica Trial

Acronym: PETREBED

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 10, 2017
Registry last updated
Jul 2, 2017

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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