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

NCT06561802 | Completed

• 1 other identifier: 2019-TDR-SABE-0009
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• The total amount of MMP-8 in GCF and saliva

  24 hours after taking the clinical measurements at the first visit

Study Arms (3)

periodontally healthy

EXPERIMENTAL

Full-mouth clinical periodontal measurements recorded and GCF and saliva obtained.

Diagnostic Test: GCF and saliva obtaining

gingivitis

EXPERIMENTAL

Full-mouth clinical periodontal measurements recorded and GCF and saliva obtained.

Diagnostic Test: GCF and saliva obtaining

periodontitis

EXPERIMENTAL

Full-mouth clinical periodontal measurements recorded and GCF and saliva obtained.

Diagnostic Test: GCF and saliva obtaining

Interventions

GCF and saliva obtaining DIAGNOSTIC_TEST

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.

gingivitis; periodontally healthy; periodontitis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Çelebi University Department of Periodontology

Izmir, Çiğli, 35640, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 20, 2024
• Study Start: April 1, 2019
• Primary Completion: September 17, 2019
• Study Completion: September 30, 2019
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

TU (1)