IL-6, IL-17 and IL-35 Levels in the Gingival Crevicular Fluid of Patients With Periodontitis and Healthy Controls

NCT05306860 | Completed DMC

• 1 other identifier: 679620
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Periodontitis is an inflammatory disease characterized by periodontal tissue destruction caused by bacterial infection. The immune response plays an important role in the progression of periodontitis. The disease process starts with periodontopathogens in dental plaque, and tissue destruction is mainly caused by the immune response of the host to the etiological microorganism and cytokine profile through various inflammatory cytokines. The cytokine response, which plays a critical role in the pathogenesis of periodontal disease, determines the progression of the disease. Evaluation of the effects of IL-6, IL-17 and IL-35 levels in the gingival crevicular fluid on periodontal disease together with clinical parameters has been the basis of our study. This study consists of individuals with grad B-C stage III-IV periodontitis and healthy individuals, which is the subtitle of Periodontal and Periimplant Diseases and Conditions in the classification renewed in 2017. It is aimed to examine the changes and possible correlations in IL-6, IL-17, IL-35 levels as a result of biochemical examination of the samples taken from the gingival crevicular fluid. In our study, according to the new classification of 2017, gingival crevicular fluid samples collected from individuals with grade B-C stage III-IV periodontal disease and healthy individuals under appropriate conditions and techniques were measured for IL-6, IL-17 and IL-35 by enzymatic immunosorbent test (ELISA). It aims to investigate the negative/positive correlations and compare the increases-decreases.

Conditions

Periodontitis

Keywords

periodontitis; healthy gingiva; stage III; stage IV; grade b; grade c

Outcome Measures

Primary Outcomes (1)

• Measurement of GCF samples

  Measurement of IL-6, IL-17, IL-35 levels in GCF in grade B-C stage III-IV periodontitis individuals.

  GCF samples were collected after first week of clinical periodontal measurement. GCF was obtained using paper strips from the deepest gingival groove.

Secondary Outcomes (1)

• Measurement of GCF samples

  GCF samples were collected after first week of clinical periodontal measurement. GCF was obtained using paper strips from the deepest gingival groove.

Study Arms (2)

Grade B-C stage III-IV periodontitis group

Grade B-C stage III-IV periodontitis group Grade B: Moderate Moderate bone loss is observed compared to biofilm and % Root Bone Loss/age 0.25 to 1.0 is determined as grade B. Stage III: Severe Consisted of individuals with interdental AL ≥5 mm, radiographic bone lose extending to middle or apical third of the root, PD≥6 mm and tooth loss due to periodontitis of ≤4. Grade C: Rapid Rapid bone loss is observed compared to biofilm and % Root Bone Loss/age \>1.0 is determined as grade C. Stage IV:Advanced Consisted of individuals with interdental AL ≥5 mm, radiographic bone lose extending to middle or apical third of the root, PD≥6 mm and tooth loss due to periodontitis of ≥5. Need for complex rehabilition due to: Masticatory dysfunction, Secondary occlusal trauma(tooth mobility degree ≥2) Severe ridge defect,Bite collapse, drifting, flaring. Less than 20 remaining teeth (10 opposing pairs)

Other: No intervention was applied to the groups the samples will be collected in terms of the diagnosis (periodontitis, healthy)

Healthy control group

Consisted of individuals with clinically healthy gingiva on an intact periodontium who had a BOP score less than 10% and PD≤3mm, showed no attachment loss or radiographic bone loss.

Other: No intervention was applied to the groups the samples will be collected in terms of the diagnosis (periodontitis, healthy)

Interventions

No intervention was applied to the groups the samples will be collected in terms of the diagnosis (periodontitis, healthy) OTHER

No intervention was applied to the groups the samples will be collected in terms of the diagnosis (periodontitis, healthy)

Grade B-C stage III-IV periodontitis group; Healthy control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In our study, individuals who have Grade B-C stage III-IV periodontal disease according to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions and individuals who have healthy gingiva will be selected.

You may qualify if:

• years old
• Not having any systemic disease (diseases that do not affect the periodontal status)
• Non-smoker
• Have not received antibiotic treatment and/or used immunosuppressant medication in the last 6 months
• Have not received any periodontal treatment before
• No pregnancy and breastfeeding status
• Not using any medication regularly
• Having at least 20 teeth
• Those with grade B-C stage III-IV periodontal disease according to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions
• In patients who applied to Istanbul University Faculty of Dentistry, Department of Periodontology, periodontally healthy individuals who do not meet the above disease criteria, who do not have a history of periodontitis in any way, will be included in the study. Consisted of individuals with clinically healthy gingiva on an intact periodontium who had a BOP score less than 10% and PD≤3mm, showed no attachment loss or radiographic bone loss.

You may not qualify if:

• Those with systemic modifying disease affecting periodontal status
• Smoker
• Have received antibiotic therapy or immunosuppressive therapy in the last 6 months
• Previously received periodontal treatment in the last 6 months
• Pregnancy and breastfeeding status
• Regular use of drugs that will affect systemic health

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Faculty of Dentistry

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

• Cekici A, Kantarci A, Hasturk H, Van Dyke TE. Inflammatory and immune pathways in the pathogenesis of periodontal disease. Periodontol 2000. 2014 Feb;64(1):57-80. doi: 10.1111/prd.12002.

  PMID: 24320956 RESULT

• Batool H, Nadeem A, Kashif M, Shahzad F, Tahir R, Afzal N. Salivary Levels of IL-6 and IL-17 Could Be an Indicator of Disease Severity in Patients with Calculus Associated Chronic Periodontitis. Biomed Res Int. 2018 Feb 18;2018:8531961. doi: 10.1155/2018/8531961. eCollection 2018.

  PMID: 29670909 RESULT

• Raj SC, Panda SM, Dash M, Patnaik K, Mohanty D, Katti N, Mahapatra A, Mishra D, Praharaj K. Association of Human Interleukin-35 Level in Gingival Crevicular Fluid and Serum in Periodontal Health, Disease, and after Nonsurgical Therapy: A Comparative Study. Contemp Clin Dent. 2018 Apr-Jun;9(2):293-297. doi: 10.4103/ccd.ccd_51_18.

  PMID: 29875576 RESULT

• Taniguchi T. Cytokine signaling through nonreceptor protein tyrosine kinases. Science. 1995 Apr 14;268(5208):251-5. doi: 10.1126/science.7716517.

  PMID: 7716517 RESULT

• Taubman MA, Yoshie H, Ebersole JL, Smith DJ, Olson CL. Host response in experimental periodontal disease. J Dent Res. 1984 Mar;63(3):455-60. doi: 10.1177/00220345840630031801.

  PMID: 6607940 RESULT

• Altaca M, Cebesoy EI, Kocak-Oztug NA, Bingul I, Cifcibasi E. Interleukin-6, -17, and -35 levels in association with clinical status in stage III and stage IV periodontitis: a cross-sectional study. BMC Oral Health. 2024 Aug 30;24(1):1015. doi: 10.1186/s12903-024-04751-3.

  PMID: 39215253 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gingival Crevicular Fluid

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Emine Çifcibaşı, Assoc.Prof.

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: April 1, 2022
• Study Start: April 15, 2022
• Primary Completion: November 30, 2022
• Study Completion: June 30, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)