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Recruiting NCT06186908

Evaluation of Salivary Gal-7, Gal-10 and MMP-9 Levels of Individuals With Different Periodontal Diseases

No phase Interventional Periodontal Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Saliva obtaining.
Who it may be relevant to
Registry conditions: Periodontal Diseases. Basic parameters: 20 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Assessment of Saliva Galectin-7, Galectin-10 and MMP-9 Levels In Individuals With Different Periodontal Diseases

Overview

The aim of this study is; detection of Galectin-10, Galectin-7, MMP-9 levels in saliva samples of periodontally healthy, gingivitis and periodontitis patients and the possible correlation between these values and clinical parameters of periodontal diseases. Materials and methods: Samples of saliva were obtained from 60 systemically healthy non-smoker individuals with periodontitis (P, n=20), gingivitis(G, n=20) and healthy periodontium (S, n=20). Full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were also recorded. Enzyme-linked immunosorbent assay (ELISA) was used to determine Galectin-10, Galectin-7 and MMP-9 levels in the biological samples.

Interventions

  • Diagnostic test 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. Tubes were stored at -80ºC until the day

Primary outcome measures

  • The total amount of Gal-10 in saliva [Time frame: 24 hours after taking the clinical measurements at the first visit]
  • The total amount of Gal-7 in saliva [Time frame: 24 hours after taking the clinical measurements at the first visit]
  • The total amount of MMP-9 in saliva [Time frame: 24 hours after taking the clinical measurements at the first visit]

Eligibility criteria

Inclusion criteria

  • Systemically healthy (The determination of healthy volunteers will be based on the statements of the patients in the anamnesis. No additional examinations will be made.)
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Turkey (Türkiye) · 1 center
  • Izmir Katip Çelebi University Department of Periodontology — Izmir

Identifiers

NCT: NCT06186908 · 2023-TDU-DİŞF-0015

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗