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Completed

NCT Number: NCT04383561

Relationship Between LRG and Periodontal Disease

This study aimed to investigate gingival crevicular fluid (GCF) and serum levels of LRG, interleukin (IL)-6 and tumor necrosis factor (TNF)-α in patients with periodontitis before and after non-surgical periodontal treatment.

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Key information

Conditions

Periodontitis Acute-Phase Reaction Acute-Phase Response Inflammation Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Stomatognathic Diseases

Age range

26 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Giresun University

Giresun, 28100, Turkey (Türkiye)

About this study

Twenty-five stage 3 periodontitis and twenty-five periodontally healthy individuals were enrolled in the study. Clinical periodontal measurements were recorded; periodontitis patients received non-surgical periodontal treatment, and GCF and serum samples were obtained at baseline and at 6 weeks after treatment. LRG, IL-6 and TNF-α were determined by ELISA.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 25-50 years of age
  • having at least 20 natural teeth, excluding third molars
  • having no systemic disease
  • non-smokers
  • criteria for healthy control group: BOP < 10% and PD ≤ 3 mm without clinical attachment loss or radiographic sign of alveolar bone destruction
  • criteria for stage 3 periodontitis group: interdental CAL ≥ 5 mm at least 2 non-adjacent teeth, PD ≥ 6 mm and radiographic bone loss extending to the mid-third of the root or beyond.

Exclusion criteria

  • having any systemic diseases,
  • smoking
  • current pregnancy or lactation
  • a history of periodontal treatment in the past 6 months
  • using antibiotic, anti-inflammatory drugs or any other drugs within the past 6 months.

Treatment and study plan

Non-surgical periodontal treatment

Other

Scaling and root planing (SRP), in four clinical visits

Oral Hygiene Instructions

Other

Oral hygiene instructions includes brushing with the modified Bass technique, interdental cleaning with dental floss and interdental brushes.

Primary outcomes

  1. Changes in the levels of biochemical parameters

    Time frame: Baseline and 6 weeks after treatment

    The levels LRG, IL-6 and TNF-α were determined to define the diagnostic and prognostic potential as a biomarker in periodontitis.

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Collaborators

  • Bulent Ecevit University
  • Giresun University

Registry information

Official study title

Leucin-rich alpha2 Glycoprotein (LRG): A Novel Acute Phase Protein Related With Stage 3 Periodontitis

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 12, 2020
Registry last updated
May 12, 2020

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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