Evaluation of GCF And Salivary Ferritin, ALP And MMP-8 Levels of Individuals With Different Periodontal Diseases

Evaluation Of Gingival Crevicular Fluid And Salivary Ferritin, Alkaline Phosphatase And Matrix Metalloproteinase-8 Levels Of Individuals With Different Periodontal Diseases

The aim of this clinical study was to determine the levels of ferritin, alkaline phosphatase and matrix metalloproteinase-8 in the gingival crevicular fluid (GCF) and saliva samples were collected from 60 systemically healthy, non-smoker periodontitis (P group, n = 20), gingivitis (G group, n = 20) and periodontally healthy individuals (S group, n = 20) and all clinical parameters were recorded for all groups at baseline. GCF and serum samplings and clinical records were also repeated at 1st and 3rd months visitsfor only P group. Ferritin, MMP8, and ALP levels in samples were determined by enzyme-linked immunosorbent assay (ELISA).

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Diagnostic test: GCF and saliva obtaining

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Çiğli
    • İzmir, Çiğli, Turkey, 35640
      • Izmir Katip Çelebi University Department of Periodontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Systemically healthy
• At least twenty permanent teeth in the mouth
• Non-smoker
• No medication for continuous use
• Those who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months.
• Not in pregnancy or lactation period.

• For the periodontitis group that has not received periodontal treatment in the last 6 months

  • For the periodontitis group; According to the evaluation made in 6 regions of each tooth, individuals with 30% or more bleeding on probing area, at least 2 teeth not adjacent to each quarter jaw with a depth of 5 mm or more and 4 mm or more attachment loss, coronal 1/3 and more on radiography (horizontal and / or vertical) bone loss
  • For the gingivitis group; According to the evaluation made in 6 regions of each tooth, individuals with 10% or more bleeding on probing area, having a probing depth of less than 4mm and no attachment loss
  • For healthy group; According to the evaluation made in 6 regions of each tooth,individuals with less than 10% bleeding on probing area, having a probing depth less than 4mm and no loss of attachment were included in the study.

Exclusion Criteria:

• Any oral or systemic disease
• Regularly using a systemic medication
• During pregnancy or lactation
• Received periodontal treatment within the last 6 months.
• Those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months
• Smokers are not included in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: periodontally healthy; Full-mouth clinical periodontal measurements recorded and GCF and saliva obtained.	Diagnostic test: GCF and saliva obtaining; The patient was asked to sit upright and tilt his/her head forward to collect saliva samples. İn this way, unstimulated saliva was allowed to accumulate in the floor of the mouth. The accumulated saliva was collected in a sterile container. It was then transferred to a propylene tube. The tubes were centrifuged and the clear part at the top of the tube was taken with a sterile syringe and transferred to a different propylene tube with 0.5 ml in each tube. Also, 4 samples of gingival crevicular fluid, 1 from each quadrant of the patient's jaw, were collected by means of paper strips and put into propylene tube. Tubes were stored at -80ºC until the day of analysis.
Experimental: gingivitis; Full-mouth clinical periodontal measurements recorded and GCF and saliva obtained.	Diagnostic test: GCF and saliva obtaining; The patient was asked to sit upright and tilt his/her head forward to collect saliva samples. İn this way, unstimulated saliva was allowed to accumulate in the floor of the mouth. The accumulated saliva was collected in a sterile container. It was then transferred to a propylene tube. The tubes were centrifuged and the clear part at the top of the tube was taken with a sterile syringe and transferred to a different propylene tube with 0.5 ml in each tube. Also, 4 samples of gingival crevicular fluid, 1 from each quadrant of the patient's jaw, were collected by means of paper strips and put into propylene tube. Tubes were stored at -80ºC until the day of analysis.
Experimental: periodontitis; Full-mouth clinical periodontal measurements recorded and GCF and saliva obtained.	Diagnostic test: GCF and saliva obtaining; The patient was asked to sit upright and tilt his/her head forward to collect saliva samples. İn this way, unstimulated saliva was allowed to accumulate in the floor of the mouth. The accumulated saliva was collected in a sterile container. It was then transferred to a propylene tube. The tubes were centrifuged and the clear part at the top of the tube was taken with a sterile syringe and transferred to a different propylene tube with 0.5 ml in each tube. Also, 4 samples of gingival crevicular fluid, 1 from each quadrant of the patient's jaw, were collected by means of paper strips and put into propylene tube. Tubes were stored at -80ºC until the day of analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The total amount of Ferritin in GCF and saliva	24 hours after taking the clinical measurements at the first visit
The total amount of ALP in GCF and saliva	24 hours after taking the clinical measurements at the first visit

Secondary Outcome Measures

Outcome Measure	Time Frame
The total amount of MMP-8 in GCF and saliva	24 hours after taking the clinical measurements at the first visit

Collaborators and Investigators

• Sponsor: Izmir Katip Celebi University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): September 17, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: August 16, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: 2019-TDR-SABE-0009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No