Evaluation of SOST, TWEAK, RANKL, OPG Levels in Smokers and Non-Smokers With Periodontitis

NCT ID: NCT06103578

Last Updated: 2023-10-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 78 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-09-04

Brief Summary

Periodontitis is a chronic inflammatory disease with multifactorial etiology. Although periodontal disease is initiated by pathogens within the biofilm layer, disease development and tissue destruction occur as a result of the interaction of periodontal pathogens and the host immune response. It has been determined in the literature that smoking has a significant negative effect on periodontal tissues and increases the risk of periodontitis by 2-5 times. It has been shown that there is a relationship between smoking and the incidence and progression of periodontitis. However, the mechanisms by which this occurs have not been explained. In this study, the effect of smoking on the levels of sclerostin (SOST), tumor necrosis factor-like weak inducer of apoptosis (TWEAK), receptor activator of nuclear factor-kB ligand (RANKL), and osteoprotegerin (OPG), which are effective in bone metabolism, in gingival crevicular fluid (GCF) and saliva will be evaluated. Participants in the study were in accordance with the 2017 World Workshop on Classification of Periodontal and Peri-implant Diseases and Conditions criteria as a result of clinical evaluations systemically healthy, non-smokers diagnosed with stage 2, 3 and/or 4 periodontitis (Group 1) (n=26); systemically healthy, diagnosed with stage 2, 3 and/or 4 periodontitis and smokers (Group 2) (n=26); systemically and periodontally healthy, non-smokers (Group 3-Control Group) (n=26). Clinical periodontal indixes will be obtained from participants meeting the inclusion criteria; GCF and saliva samples will be collected. The samples will be examined by ELISA test at Gazi University Faculty of Medicine, Department of Immunology.

Conditions

Periodontitis; Smoking

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-smoker periodontitis

GCF and saliva analysis

Intervention Type: DIAGNOSTIC_TEST

ELISA

Smoker periodontitis

GCF and saliva analysis

Intervention Type: DIAGNOSTIC_TEST

ELISA

Control

GCF and saliva analysis

Intervention Type: DIAGNOSTIC_TEST

ELISA

Interventions

GCF and saliva analysis

ELISA

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Study participants have no history of periodontal therapy or drug therapy for at least 6 months.

Exclusion Criteria

• Pregnancy, lactation, during orthodontic treatment and systemic conditions related to bone metabolism, diabetes were excluded.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Ece Güner

Assistant researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ece Güner, Phd

Role: STUDY_CHAIR

Gazi University Faculty of Dentistry

Gülay Tüter, Professor

Role: STUDY_DIRECTOR

Gazi University

Locations

Ece Güner

Yenimahalle, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Gur AT, Guncu GN, Akman AC, Pinar A, Karabulut E, Nohutcu RM. Evaluation of GCF IL-17, IL-10, TWEAK, and sclerostin levels after scaling and root planing and adjunctive use of diode laser application in patients with periodontitis. J Periodontol. 2022 Aug;93(8):1161-1172. doi: 10.1002/JPER.21-0494. Epub 2022 Jan 25.

Reference Type: RESULT

PMID: 34962665 (View on PubMed)

Rezaei Esfahrood Z, Yadegari Z, Veysari SK, Kadkhodazadeh M. Gingival crevicular fluid levels of sclerostin in chronic periodontitis and healthy subjects. J Korean Assoc Oral Maxillofac Surg. 2018 Dec;44(6):289-292. doi: 10.5125/jkaoms.2018.44.6.289. Epub 2018 Dec 28.

Reference Type: RESULT

PMID: 30637243 (View on PubMed)

Teodorescu AC, Martu I, Teslaru S, Kappenberg-Nitescu DC, Goriuc A, Luchian I, Martu MA, Solomon SM, Martu S. Assessment of Salivary Levels of RANKL and OPG in Aggressive versus Chronic Periodontitis. J Immunol Res. 2019 Apr 28;2019:6195258. doi: 10.1155/2019/6195258. eCollection 2019.

Reference Type: RESULT

PMID: 31183390 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

6362

Identifier Type: -

Identifier Source: org_study_id