Back to resultsRelationship Between LRG and Periodontal Disease
Primary Purpose
Periodontitis, Acute-Phase Response, Inflammation
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Non-surgical periodontal treatment
Oral hygiene instructions
Sponsored by
About this trial
This is an interventional diagnostic trial for Periodontitis focused on measuring periodontitis, gingival crevicular fluid, serum
Eligibility Criteria
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.
Sites / Locations
- Giresun University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
stage 3 periodontitis
Periodontally healthy controls
Arm Description
GCF and serum samples were collected before and after treatment from periodontitis patients.
GCF and serum samples were collected from periodontally healthy controls at baseline for once.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04383561
First Posted
May 4, 2020
Last Updated
May 7, 2020
Sponsor
Aydin Adnan Menderes University
Collaborators
Giresun University, Bulent Ecevit University
1. Study Identification
Unique Protocol Identification Number
NCT04383561
Brief Title
Relationship Between LRG and Periodontal Disease
Official Title
Leucin-rich alpha2 Glycoprotein (LRG): A Novel Acute Phase Protein Related With Stage 3 Periodontitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
January 15, 2020 (Actual)
Study Completion Date
February 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University
Collaborators
Giresun University, Bulent Ecevit University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Acute-Phase Response, Inflammation
Keywords
periodontitis, gingival crevicular fluid, serum
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
stage 3 periodontitis
Arm Type
Active Comparator
Arm Description
GCF and serum samples were collected before and after treatment from periodontitis patients.
Arm Title
Periodontally healthy controls
Arm Type
Placebo Comparator
Arm Description
GCF and serum samples were collected from periodontally healthy controls at baseline for once.
Intervention Type
Other
Intervention Name(s)
Non-surgical periodontal treatment
Intervention Description
Scaling and root planing (SRP), in four clinical visits
Intervention Type
Other
Intervention Name(s)
Oral hygiene instructions
Intervention Description
Oral hygiene instructions includes brushing with the modified Bass technique, interdental cleaning with dental floss and interdental brushes.
Primary Outcome Measure Information:
Title
Changes in the levels of biochemical parameters
Description
The levels LRG, IL-6 and TNF-α were determined to define the diagnostic and prognostic potential as a biomarker in periodontitis.
Time Frame
Baseline and 6 weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
26 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Giresun University
City
Giresun
ZIP/Postal Code
28100
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Relationship Between LRG and Periodontal Disease
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