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 | Active Not Recruiting

• 1 other identifier: 2024/01-16
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• assesment of Gremlin-1 pre-treatment

  Measurement of Gremlin-1 levels using an ELISA kit from gingival crevicular fluid samples taken from patients before periodontitis treatment.

  From enrollment to the end of treatment at 3 months

• assesment of syndecan-4 pre treatment

  Measurement of Syndecan-4- levels using an ELISA kit from gingival crevicular fluid samples taken from patients before periodontitis treatment.

  From enrollment to the end of treatment at 3 months

• Assesment of IL-1 Beta pre-treatment

  Measurement of IL-1 Beta levels using an ELISA kit from gingival crevicular fluid samples taken from patients before periodontitis treatment.

  From enrollment to the end of treatment at 3 months

Study Arms (3)

Smokers with stage 3 periodontitis

Procedure: non-surgical periodontal therapy

Non-smokers with stage 3 periodontitis

Procedure: non-surgical periodontal therapy

Healthy Participant

Interventions

non-surgical periodontal therapy PROCEDURE

non-surgical periodontal therapy

Non-smokers with stage 3 periodontitis; Smokers with stage 3 periodontitis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study will include a total of 45 volunteer individuals, consisting of 15 smokers and 15 non-smokers diagnosed with stage 3 periodontitis, aged 18-60, who seek treatment for periodontal complaints such as pain, sensitivity, and gum recession at the Department of Periodontology, Faculty of Dentistry, Atatürk University, as well as 15 healthy individuals. The sampling procedure will be carried out at the Department of Periodontology, Faculty of Dentistry, Atatürk University, with the approval of the ethical committee report from the Scientific Research Ethics Committee of Erzurum Medical Faculty.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tugba Aydin: lead

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis; Polyposis Syndrome, Hereditary Mixed, 1

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: TAYdin

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 13, 2024
• Study Start: April 1, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)