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

Smoking Clinical Trial

Official title:

Evaluation of Gingival Crevicular Fluid and Saliva SOST and TWEAK, Gingival Crevicular Fluid RANKL and OPG Levels in Smokers and Non-smokers With Periodontitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06103578
• Other study ID #: 6362
• Status: Completed
• Start date: December 1, 2021
• Est. completion date: September 4, 2023

Study information

• Verified date: October 2023
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: September 4, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis
• Smoking

Intervention

Diagnostic Test:
• GCF and saliva analysis
ELISA

Locations

Country	Name	City	State
Turkey	Ece Güner	Yeni?mahalle	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & 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 — View Citation

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 — View Citation

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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.