Ireland
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Active, not recruiting Observational

Comparative Analysis of Gremlin-1, Syndecan-4 and IL-1 Beta Levels in Gingival Crevicular Fluid Among İndividuals With Periodontal Health and Stage III Periodontitis, Considering Both Smokers and Non-Smokers, Before and After Non-Surgical Periodontal Therapy

NCT06687005 · tracked via the Priya Life Science Turkey tracker
Sponsor
Tugba Aydin
Phase
Observational
Started
2024-04-01
Last updated
2024-11-13

Condition(s) studied

Periodontitis (Stage 3)Gremlin-1Syndecan 4Interleukin 1-beta

Investigational drug(s) / intervention(s)

non-surgical periodontal therapy

non-surgical periodontal therapy: non-surgical periodontal therapy

Study summary

eriodontitis is a complex disease characterized by the inflammation and destruction of the tissues supporting the teeth, and smoking can adversely affect the pathophysiological changes in this process. In an unhealthy periodontium, the host's inflammatory response products can be detected in the content of DOS, and the presence of these components is crucial in obtaining information about the pathogenesis of periodontal disease. Biochemical markers found in DOS are significantly helpful in determining the active stages and regions of the disease and in evaluating the host response to periodontal treatment. IL-1β has been determined to play a leading role in the pathogenic mechanism of periodontal tissue destruction, and the degree of inflammation in the tissues can be measured by IL-1β activity in DOS. Syndecan-4, a member of the transmembrane heparan sulfate proteoglycan family, regulates cellular activities such as tissue homeostasis, inflammation, fibrosis, and tumor metastasis. Gremlin-1 is a protein that inhibits BMP (Bone Morphogenetic Protein) signaling, influencing cell growth and tissue development. Gremlin-1 plays an important role in tissue repair and regeneration, modulating inflammatory processes and regulating cellular homeostasis. While recent studies have explained the role of Syndecan-4 and Gremlin-1 in inflammation, their effects on periodontal tissues are still quite limited in the literature. Our study aims to investigate the effects of smoking on these biomarkers by comparing the periodontal status before and after treatment of healthy, smoking, and non-smoking individuals with stage 3 periodontitis, with the goal of developing early diagnostic tools in the future.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
Accepted
Inclusion Criteria: * The volunteers must not have any systemic diseases. * The volunteers must be between 18 and 60 years of age. * Control group: Periodontally healthy patients with no signs of periodontal disease and no history of smoking. * Study Group I: Non-smoking patients with stage III periodontitis, evaluated based on clinical findings such as PD ≥ 5 mm and CAL ≥ 4 mm (with ≥ 30% of affected teeth), without radiographic evidence of bone loss and a history of smoking. * Study Group II: Smoking patients with untreated stage III periodontitis, evaluated based on clinical findings such as PD ≥ 5 mm and CAL ≥ 4 mm (with ≥ 30% of affected teeth), with radiographic evidence of bone loss and a history of smoking for at least 10 cigarettes per day over the past 3 years. Exclusion Criteria: * The individual's unwillingness to participate in the study * Being outside the specified age range * Pregnant or breastfeeding patients * Having a systemic disease * Smoking in the past 10 years * Having received periodontal treatment within the last 6 months

Primary outcome measure(s)

  • assesment of Gremlin-1 pre-treatment — From enrollment to the end of treatment at 3 months
    Measurement of Gremlin-1 levels using an ELISA kit from gingival crevicular fluid samples taken from patients before periodontitis treatment.
  • assesment of syndecan-4 pre treatment — From enrollment to the end of treatment at 3 months
    Measurement of Syndecan-4- levels using an ELISA kit from gingival crevicular fluid samples taken from patients before periodontitis treatment.
  • Assesment of IL-1 Beta pre-treatment — From enrollment to the end of treatment at 3 months
    Measurement of IL-1 Beta levels using an ELISA kit from gingival crevicular fluid samples taken from patients before periodontitis treatment.

Trial sites (1)

FacilityCityRegionStatus
Ataturk University Erzurum Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06687005 on ClinicalTrials.gov ↗ ← All trials in Turkey