IL-10, IL-12 and IL-18 Levels in the Gingival Crevicular Fluid of Patients With Periodontitis and Healthy Controls

NCT05307068 | Completed DMC

• 1 other identifier: 679625
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Periodontitis is a multifactorial chronic inflammatory disease characterized by the destruction of the tissues supporting the tooth. The incidence and rate of progression of periodontal destruction involves a complex interaction between periodontopathic bacteria and immune system cells. The complex cytokine network that mediates the immune response includes pro-inflammatory cytokines, anti-inflammatory cytokines, and specific cytokine receptors. Cytokines act as messengers to initiate, mediate, and control immune and inflammatory responses. It is known that the interaction of pro- and anti-inflammatory cytokines plays a very important role in the progression of periodontitis . The immune response to infection is regulated by the balance between T helper (Th)1 and Th2-type cytokines. Since Th1, Th2, and monocyte-derived cytokines in gingival tissues and gingival crevicular fluid (GCF) play a role in periodontal inflammation, even a minimal imbalance in cytokine production may affect the induction of bone and collagen resorption in periodontal disease. For this reason, cytokines in inflamed periodontal tissues, which are the focus of many studies, are of great importance in the progression of periodontal disease. In this study, our aim is to evaluate the local cytokine response in relation to the clinical periodontal status by determining the IL-10, IL-12 and IL-18 concentrations in the gingival crevicular fluid of individuals with grade B-C stage III-IV periodontitis according to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions. In this way, besides clinical and radiographic determinations in the diagnosis of periodontal disease, IL-10, IL-12 and IL-18 are measured to evaluate whether these markers have an effect on the diagnosis of the disease.

Conditions

Periodontitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Measurement of GCF samples

  Measurement of IL-10, IL-12, IL-18 levels in GCF with 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: 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 in the last 6 months
• No pregnancy and lactation
• Not using any medication regularly
• Having at least 20 teeth
• 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)

• Geng Y, Li L, Wang X, He F, Zhou Y, Yang M, Xu Y. Interleukin-10 polymorphisms affect the key periodontal pathogens in Chinese periodontitis patients. Sci Rep. 2018 Jun 13;8(1):9068. doi: 10.1038/s41598-018-26236-4.

  PMID: 29899423 RESULT

• Borilova Linhartova P, Danek Z, Deissova T, Hromcik F, Lipovy B, Szaraz D, Janos J, Fassmann A, Bartova J, Drizhal I, Izakovicova Holla L. Interleukin Gene Variability and Periodontal Bacteria in Patients with Generalized Aggressive Form of Periodontitis. Int J Mol Sci. 2020 Jul 2;21(13):4728. doi: 10.3390/ijms21134728.

  PMID: 32630798 RESULT

• Orozco A, Gemmell E, Bickel M, Seymour GJ. Interleukin-1beta, interleukin-12 and interleukin-18 levels in gingival fluid and serum of patients with gingivitis and periodontitis. Oral Microbiol Immunol. 2006 Aug;21(4):256-60. doi: 10.1111/j.1399-302X.2006.00292.x.

  PMID: 16842511 RESULT

• Pai B S, Pradeep AR. Correlations between Interleukin-33 and -1alpha Levels in Gingival Crevicular Fluid and Plasma in Patients with Chronic or Aggressive Periodontitis and Disease-free Subjects. Bull Tokyo Dent Coll. 2019 Dec 10;60(4):279-289. doi: 10.2209/tdcpublication.2019-0002. Epub 2019 Nov 22.

  PMID: 31761881 RESULT

• Park AY, Scott P. Il-12: keeping cell-mediated immunity alive. Scand J Immunol. 2001 Jun;53(6):529-32. doi: 10.1046/j.1365-3083.2001.00917.x.

  PMID: 11422900 RESULT

• Clarke IJ, Tilbrook AJ, Galloway DB, Earl CR, Findlay JK, de Kretser DM. Inhibin in rams. J Reprod Fertil Suppl. 1991;43:163-70. No abstract available.

  PMID: 1843338 RESULT

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: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)