Relationship Between LRG and Periodontal Disease

Not Applicable

Completed

• Conditions: Inflammation; Periodontitis; Acute-Phase Response
• Interventions: Other: Non-surgical periodontal treatment; Other: Oral hygiene instructions

• Registration Number: NCT04383561
• Lead Sponsor: Aydin Adnan Menderes University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-09-30
• Primary Completion: 2020-01-15
• Study Completion: 2020-02-15
• Status Verified: 2020-05
• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-07
• Last Update Submitted: 2020-05-07
• Study First Posted: 2020-05-12
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stage 3 periodontitis	Non-surgical periodontal treatment	GCF and serum samples were collected before and after treatment from periodontitis patients.
stage 3 periodontitis	Oral hygiene instructions	GCF and serum samples were collected before and after treatment from periodontitis patients.
Periodontally healthy controls	Oral hygiene instructions	GCF and serum samples were collected from periodontally healthy controls at baseline for once.

Primary Outcome Measures

Name	Time	Method
Changes in the levels of biochemical parameters	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.

Trial Locations

Locations (1)

Giresun University; 🇹🇷 Giresun, Turkey