Relationship Between LRG and Periodontal Disease

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04383561
• Other study ID #: KAEK-92
• Status: Completed
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: February 15, 2020

Study information

• Verified date: May 2020
• Source: Aydin Adnan Menderes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 26 Years to 49 Years

Eligibility

Inclusion Criteria:

1. 25-50 years of age

2. having at least 20 natural teeth, excluding third molars

3. having no systemic disease

4. non-smokers

5. criteria for healthy control group: BOP < 10% and PD = 3 mm without clinical attachment loss or radiographic sign of alveolar bone destruction

6. 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:

1. having any systemic diseases,

2. smoking

3. current pregnancy or lactation

4. a history of periodontal treatment in the past 6 months

5. using antibiotic, anti-inflammatory drugs or any other drugs within the past 6 months.

Related Conditions & MeSH terms

• Acute-Phase Reaction
• Acute-Phase Response
• Inflammation
• Periodontitis

Intervention

Other:
• Non-surgical periodontal treatment
Scaling and root planing (SRP), in four clinical visits
• Oral hygiene instructions
Oral hygiene instructions includes brushing with the modified Bass technique, interdental cleaning with dental floss and interdental brushes.

Locations

Country	Name	City	State
Turkey	Giresun University	Giresun

Sponsors (3)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University	Bulent Ecevit University, Giresun University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the levels of biochemical parameters	The levels LRG, IL-6 and TNF-a were determined to define the diagnostic and prognostic potential as a biomarker in periodontitis.	Baseline and 6 weeks after treatment