Relationship Between LRG and Periodontal Disease
Leucin-rich alpha2 Glycoprotein (LRG): A Novel Acute Phase Protein Related With Stage 3 Periodontitis
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2020
CompletedFirst Submitted
Initial submission to the registry
May 4, 2020
CompletedFirst Posted
Study publicly available on registry
May 12, 2020
CompletedMay 12, 2020
May 1, 2020
4 months
May 4, 2020
May 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in the levels of biochemical parameters
The levels LRG, IL-6 and TNF-α were determined to define the diagnostic and prognostic potential as a biomarker in periodontitis.
Baseline and 6 weeks after treatment
Study Arms (2)
stage 3 periodontitis
ACTIVE COMPARATORGCF and serum samples were collected before and after treatment from periodontitis patients.
Periodontally healthy controls
PLACEBO COMPARATORGCF and serum samples were collected from periodontally healthy controls at baseline for once.
Interventions
Scaling and root planing (SRP), in four clinical visits
Oral hygiene instructions includes brushing with the modified Bass technique, interdental cleaning with dental floss and interdental brushes.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aydin Adnan Menderes Universitylead
- Giresun Universitycollaborator
- Bulent Ecevit Universitycollaborator
Study Sites (1)
Giresun University
Giresun, 28100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Prof.
Study Record Dates
First Submitted
May 4, 2020
First Posted
May 12, 2020
Study Start
September 30, 2019
Primary Completion
January 15, 2020
Study Completion
February 15, 2020
Last Updated
May 12, 2020
Record last verified: 2020-05