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

NCT06103578 | Completed

• 1 other identifier: 6362
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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

Keywords

periodontitis; smoking; RANKL; OPG; TWEAK; SOST

Outcome Measures

Primary Outcomes (9)

• Plaque index (Silness & Löe )

  This index ascertains the thickness of plaque along the gingival margin. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. The scores from the four areas of the tooth are added and divided by four for each tooth score. When creating the whole mouth score, the arithmatic average of all tooth scores was taken.

  Clinical periodontal indices were recorded at the participants' first visit.

• Gingival index (Löe & Silness)

  Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. The scores from the four areas of the tooth are added and divided by four for each tooth score. When creating the whole mouth score, the arithmatic average of all tooth scores was taken.

  Clinical periodontal indices were recorded at the participants' first visit.

• Probing depth

  Probing depth is the distance from the gingival margin to the apical portion of the gingival sulcus. The scores from the four areas of the tooth are added and divided by four for each tooth score. It is recorded as mm. When creating the whole mouth score, the arithmatic average of all tooth scores was taken.

  Clinical periodontal indices were recorded at the participants' first visit.

• Attachment loss

  The scores from the four areas of the tooth are added and divided by four for each tooth score. It is recorded as mm. When creating the whole mouth score, the arithmatic average of all tooth scores was taken.

  Clinical periodontal indices were recorded at the participants' first visit.

• Bleeding on probing

  All four surfaces of all teeth are assessed with regard to whether probing elicits bleeding (+) or not (-).It is recorded as a percentage by umber of bleeding sites is number of sites evaluated and multiplying by one hundred.

  Clinical periodontal indices were recorded at the participants' first visit.

• Determination of GCF and Saliva SOST level

  Determination of SOST levels by ELISA method. It is recorded as pg/ml.

  1 month after all saliva and gingival crevicular fluid samples of the participants were collected between 01.12.2021-30.09.2022, SOST, TWEAK, RANKL and OPG levels were examined by ELISA method.

• Determination of GCF and Saliva TWEAK level

  Determination of TWEAK levels by ELISA method. It is recorded as mg/l.

  1 month after all saliva and gingival crevicular fluid samples of the participants were collected between 01.12.2021-30.09.2022, SOST, TWEAK, RANKL and OPG levels were examined by ELISA method.

• Determination of GCF RANKL level

  Determination of RANKL levels by ELISA method. It is recorded as pg/ml.

  1 month after all saliva and gingival crevicular fluid samples of the participants were collected between 01.12.2021-30.09.2022, SOST, TWEAK, RANKL and OPG levels were examined by ELISA method.

• Determination of GCF OPG level

  Determination of OPG levels by ELISA method. It is recorded as pg/ml.

  1 month after all saliva and gingival crevicular fluid samples of the participants were collected between 01.12.2021-30.09.2022, SOST, TWEAK, RANKL and OPG levels were examined by ELISA method.

Study Arms (3)

Non-smoker periodontitis

Diagnostic Test: GCF and saliva analysis

Smoker periodontitis

Diagnostic Test: GCF and saliva analysis

Control

Diagnostic Test: GCF and saliva analysis

Interventions

GCF and saliva analysis DIAGNOSTIC_TEST

ELISA

Control; Non-smoker periodontitis; Smoker periodontitis

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

Periodontitis: Stage 2,3,4 and grade A,B,C periodontitis non-smoker patient included. Smoking-periodontitis: Stage 2,3,4 and grade A,B,C periodontitis patients which smoking 10 or more daily for at least 10 years included. Control: Periodontally healthy, non-smoker subjects included.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Ece Güner

Yenimahalle, Ankara, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 34962665 RESULT

• 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.

  PMID: 30637243 RESULT

• 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.

  PMID: 31183390 RESULT

MeSH Terms

Conditions

Periodontitis; Smoking

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Behavior

Study Officials

• Ece Güner, Phd

  Gazi University Faculty of Dentistry

  STUDY CHAIR

• Gülay Tüter, Professor

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant researcher

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: October 27, 2023
• Study Start: December 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 4, 2023
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)