Effect of Smoking and Periodontal Therapy on Salivary and Gingival Crevicular IL-17 and IL-35

NCT05281848 | Completed

• 1 other identifier: 21071282-050.99
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

Brief Summary

Periodontal diseases are among the major causes of tooth loss. Smoking may play a role as a contributing factor in the development of periodontitis by reducing the immune response. The role of cytokines in the pathogenesis of periodontal disease is clearly indicated in the literature; it has been shown that microorganisms that cause periodontal disease cause cytokine increase in saliva, gingival tissue and gingival crevicular fluid. Among these cytokines, interleukin (IL) -17 is proinflammatory and IL-35 is antiinflammatory and has been associated with periodontal disease.

Conditions

Periodontitis; Periodontal Diseases; Smoking; Smoking, Tobacco

Keywords

periodontitis; non-surgical periodontal treatment; IL-17; IL-35; saliva; gingival crevicular fluid

Outcome Measures

Primary Outcomes (4)

• IL-17 levels in gingival crevicular fluid

  by ELISA method

  Change from baseline to 1st month after non-surgical periodontal treatment

• IL-17 levels in saliva

  by ELISA method

  Change from baseline to 1st month after non-surgical periodontal treatment

• IL-35 levels in gingival crevicular fluid

  by ELISA method

  Change from baseline to 1st month after non-surgical periodontal treatment

• IL-35 levels in saliva

  by ELISA method

  Change from baseline to 1st month after non-surgical periodontal treatment

Secondary Outcomes (5)

• Plaque Index (PI)

  Change from baseline to 1st month after non-surgical periodontal treatment

• Gingival Index (GI)

  Change from baseline to 1st month after non-surgical periodontal treatment

• Pocket Depth (PD)

  Change from baseline to 1st month after non-surgical periodontal treatment

• Bleeding in Probing Index (BOP)

  Change from baseline to 1st month after non-surgical periodontal treatment

• Clinical Attachment Loss (CAL)

  Change from baseline to 1st month after non-surgical periodontal treatment

Study Arms (3)

Smoker-Periodontitis; Non-surgical periodontal treatment

ACTIVE COMPARATOR

Procedure: Non-surgical periodontal treatment

Nonsmoker-Periodontitis;Non-surgical periodontal treatment

ACTIVE COMPARATOR

Procedure: Non-surgical periodontal treatment

Healthy

NO INTERVENTION

Interventions

Non-surgical periodontal treatment PROCEDURE

Non-surgical periodontal treatment includes periodontal prophylaxis and root planning. No other methods or any of drugs will be used.

Nonsmoker-Periodontitis;Non-surgical periodontal treatment; Smoker-Periodontitis; Non-surgical periodontal treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be volunteer to participate in the study
• To be over 18
• Being systemically healthy
• Having greater than or equal to 15 teeth out of 3rd molar teeth
• To have localized or generalized periodontitis for the experimental group (clinical attachment loss in at least 6 surrounding areas and presence of greater than or equal to 5 mm periodontal pocket)
• For Smoking group; more than 10 cigarettes a day for more than 5 years
• For non-smokers; have not smoked for at least 3 years.

You may not qualify if:

• Have any systemic disease affecting periodontal condition
• To receive periodontal treatment in the last 6 months
• Use any medication that may affect the inflammatory process in the last 3 months
• Use local or systemic antibiotics in the last 3 months
• Pregnancy or lactation for female patients
• Regular use of mouthwash

Sponsors & Collaborators

• Gazi University: lead

Study Sites (2)

Gazi University Faculty of Dentistry

Ankara, 06500, Turkey (Türkiye)

Location

Gazi University Faculty of Medicine Immunology Department

Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (13)

• Page RC, Kornman KS. The pathogenesis of human periodontitis: an introduction. Periodontol 2000. 1997 Jun;14:9-11. doi: 10.1111/j.1600-0757.1997.tb00189.x. No abstract available.

  PMID: 9567963 BACKGROUND

• Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S173-S182. doi: 10.1002/JPER.17-0721.

  PMID: 29926951 BACKGROUND

• Kinane DF, Stathopoulou PG, Papapanou PN. Periodontal diseases. Nat Rev Dis Primers. 2017 Jun 22;3:17038. doi: 10.1038/nrdp.2017.38.

  PMID: 28805207 BACKGROUND

• Page RC, Schroeder HE. Pathogenesis of inflammatory periodontal disease. A summary of current work. Lab Invest. 1976 Mar;34(3):235-49.

  PMID: 765622 BACKGROUND

• Preshaw PM. Host modulation therapy with anti-inflammatory agents. Periodontol 2000. 2018 Feb;76(1):131-149. doi: 10.1111/prd.12148. Epub 2017 Nov 29.

  PMID: 29193331 BACKGROUND

• Okada H, Murakami S. Cytokine expression in periodontal health and disease. Crit Rev Oral Biol Med. 1998;9(3):248-66. doi: 10.1177/10454411980090030101.

  PMID: 9715365 BACKGROUND

• Zhang JM, An J. Cytokines, inflammation, and pain. Int Anesthesiol Clin. 2007 Spring;45(2):27-37. doi: 10.1097/AIA.0b013e318034194e.

  PMID: 17426506 BACKGROUND

• Qiu F, Liang CL, Liu H, Zeng YQ, Hou S, Huang S, Lai X, Dai Z. Impacts of cigarette smoking on immune responsiveness: Up and down or upside down? Oncotarget. 2017 Jan 3;8(1):268-284. doi: 10.18632/oncotarget.13613.

  PMID: 27902485 RESULT

• Cua DJ, Tato CM. Innate IL-17-producing cells: the sentinels of the immune system. Nat Rev Immunol. 2010 Jul;10(7):479-89. doi: 10.1038/nri2800. Epub 2010 Jun 18.

  PMID: 20559326 RESULT

• Yao Z, Painter SL, Fanslow WC, Ulrich D, Macduff BM, Spriggs MK, Armitage RJ. Human IL-17: a novel cytokine derived from T cells. J Immunol. 1995 Dec 15;155(12):5483-6.

  PMID: 7499828 RESULT

• Vignali DA, Kuchroo VK. IL-12 family cytokines: immunological playmakers. Nat Immunol. 2012 Jul 19;13(8):722-8. doi: 10.1038/ni.2366.

  PMID: 22814351 RESULT

• Eshghipour B, Tofighi H, Nehal F, Vohra F, Javed F, Akram Z. Effect of scaling and root planing on gingival crevicular fluid cytokine/chemokine levels in smokers with chronic periodontitis: A systematic review. J Investig Clin Dent. 2018 Aug;9(3):e12327. doi: 10.1111/jicd.12327. Epub 2018 Feb 15.

  PMID: 29450974 RESULT

• Ezgi Sila T, Gulay T, Aysegul AY, Melek Y. Non-surgical periodontal treatment effects on IL-17 and IL-35 levels in smokers and non-smokers with periodontitis. Odontology. 2025 Sep 19. doi: 10.1007/s10266-025-01207-0. Online ahead of print.

  PMID: 40971113 DERIVED

MeSH Terms

Conditions

Periodontitis; Periodontal Diseases; Smoking; Tobacco Smoking

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Behavior; Tobacco Use

Study Officials

• Gülay Tüter, Professor

  Gazi University Dentistry Faculty Department of Periodontology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: A total of 55 subjects will be grouped as: 18 non-smoker patients with periodontitis (Group 1), 19 smoker patients with periodontitis (Group 2), 18 non-smoker and periodontally healthy individuals who will refer to our department. Spitting method will be used for collecting saliva samples. The paper strip method will be used for gingival crevicular fluid (GCF) sample collection. Samples will be taken from the mesial and distal surfaces of the teeth (healthy or have greater than or equal to 5mm pocket depth) after isolation from the saliva. Paper strips will be transferred to polypropylene tubes and stored at -30 ° C until inspection. After collecting samples, non-surgical periodontal treatment will be performed to all individuals which are classified as Group 1 and Group 2. Collection of saliva and GCF samples will be repeated at the 1st month after the end of treatment. ELISA kits will be used for the detection of saliva and GCF's IL-17 and IL-35.

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 16, 2022
• Study Start: January 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: March 7, 2022
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)