- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05281848
Effect of Smoking and Periodontal Therapy on Salivary and Gingival Crevicular IL-17 and IL-35
Evaluation of the Effect of Non-surgical Periodontal Treatment on Salivary and Gingival Crevicular Fluid Levels of IL-17 and IL-35 in Periodontitis Patients as Smoker and Non-smoker
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Periodontal diseases are among the complex inflammatory diseases that are considered among the leading causes of tooth loss, mostly observed with multiple etiological factors. The complexity of periodontal disease is due to the presence of the biofilm and the accompanying host response together.
Smoking, which is considered as one of the risk factors in terms of periodontitis, is one of the most preventable risk factors that affect the periodonium with many different mechanisms. Smoking plays a role in the etiopathogenesis of periodontitis, with its physiological changes in gingival tissue and its effects on host response and is considered to be an established risk factor. Although the effects of smoking on host response and its role in increasing the risk of periodontal disease are still being investigated, its effects on natural and acquired immune response cells have been studied separately. Consequently, components of cigarette suppress the immune system's defense responses; however, it has been reported to exacerbate pathological reactions.
The process of progression from periodontal health to periodontitis is formed by biofilm pathogens and host immune responses activated by these microorganisms. Intercellular communication is crucial during the progression of chronic inflammatory diseases, such as periodontitis. Cytokines, one of these ways of communication, are soluble proteins produced by various types of cells, such as structural and inflammatory cells, responsible for maintaining a complex network of communication between homotypic and heterotypic cell groups.
Interleukin-17 (IL-17) is a pro-inflammatory cytokine mostly stimulated from Th17 cells, stimulating inflammatory processes with many different mechanisms.
IL-35 inhibits the differentiation of Th17 cells and suppresses IL-17 production and therefore plays a protective role in Th17-related diseases.
There are many studies evaluating the effect of non-surgical periodontal treatment on individuals with smokers with periodontitis. However, the obtained results do not allow a clear data to be revealed. To exemplify, when the studies which investigates the evaluation of non-surgical periodontal treatment on IL-17 levels were evaluated, contradictory results were determined. In addition, as a result of our research, no studies evaluating the effects of non-surgical periodontal treatment on IL-35 levels in smokers with periodontitis have not been found.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey, 06500
- Gazi University Faculty of Dentistry
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Ankara, Turkey, 06560
- Gazi University Faculty of Medicine Immunology Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Smoker-Periodontitis; Non-surgical periodontal treatment
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Non-surgical periodontal treatment includes periodontal prophylaxis and root planning.
No other methods or any of drugs will be used.
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Active Comparator: Nonsmoker-Periodontitis;Non-surgical periodontal treatment
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Non-surgical periodontal treatment includes periodontal prophylaxis and root planning.
No other methods or any of drugs will be used.
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No Intervention: Healthy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IL-17 levels in gingival crevicular fluid
Time Frame: Change from baseline to 1st month after non-surgical periodontal treatment
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by ELISA method
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Change from baseline to 1st month after non-surgical periodontal treatment
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IL-17 levels in saliva
Time Frame: Change from baseline to 1st month after non-surgical periodontal treatment
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by ELISA method
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Change from baseline to 1st month after non-surgical periodontal treatment
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IL-35 levels in gingival crevicular fluid
Time Frame: Change from baseline to 1st month after non-surgical periodontal treatment
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by ELISA method
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Change from baseline to 1st month after non-surgical periodontal treatment
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IL-35 levels in saliva
Time Frame: Change from baseline to 1st month after non-surgical periodontal treatment
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by ELISA method
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Change from baseline to 1st month after non-surgical periodontal treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plaque Index (PI)
Time Frame: Change from baseline to 1st month after non-surgical periodontal treatment
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by using Williams periodontal probe; Scores from 0 to 3, 0 is no visible plaque, 3 is visible plaque or dental calculus.
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Change from baseline to 1st month after non-surgical periodontal treatment
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Gingival Index (GI)
Time Frame: Change from baseline to 1st month after non-surgical periodontal treatment
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by using Williams periodontal probe; Scores from 0 to 3, 0 is healthy gingiva, 3 is diseased gingiva with spontaneous bleeding.
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Change from baseline to 1st month after non-surgical periodontal treatment
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Pocket Depth (PD)
Time Frame: Change from baseline to 1st month after non-surgical periodontal treatment
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by using Williams periodontal probe with milimeter signs; Pocket Depth is registered by milimeters.
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Change from baseline to 1st month after non-surgical periodontal treatment
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Bleeding in Probing Index (BOP)
Time Frame: Change from baseline to 1st month after non-surgical periodontal treatment
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by using Williams periodontal probe; BOP is registered with + or - according to the presence of bleeding on probing.
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Change from baseline to 1st month after non-surgical periodontal treatment
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Clinical Attachment Loss (CAL)
Time Frame: Change from baseline to 1st month after non-surgical periodontal treatment
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by using Williams periodontal probe with milimeter signs; CAL is registered by milimeters.
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Change from baseline to 1st month after non-surgical periodontal treatment
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gülay Tüter, Professor, Gazi University Dentistry Faculty Department of Periodontology
Publications and helpful links
General Publications
- Zhang JM, An J. Cytokines, inflammation, and pain. Int Anesthesiol Clin. 2007 Spring;45(2):27-37. doi: 10.1097/AIA.0b013e318034194e.
- 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.
- Kinane DF, Stathopoulou PG, Papapanou PN. Periodontal diseases. Nat Rev Dis Primers. 2017 Jun 22;3:17038. doi: 10.1038/nrdp.2017.38.
- 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.
- Page RC, Schroeder HE. Pathogenesis of inflammatory periodontal disease. A summary of current work. Lab Invest. 1976 Mar;34(3):235-49.
- 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.
- 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.
- 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.
- 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. Erratum In: Nat Rev Immunol. 2010 Aug;10(8):611. Nat Rev Immunol. 2010 Jul;10(7):following 489.
- 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.
- Vignali DA, Kuchroo VK. IL-12 family cytokines: immunological playmakers. Nat Immunol. 2012 Jul 19;13(8):722-8. doi: 10.1038/ni.2366.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21071282-050.99
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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