Clinical trial NCT06103578: Evaluation of SOST, TWEAK, RANKL, OPG Levels in Smokers and Non-Smokers With Periodontitis
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Smoking
Keywords: periodontitis
smoking
RANKL
OPG
TWEAK
SOST
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Plaque index (Silness & Löe )
timeFrame: Clinical periodontal indices were recorded at the participants' first visit.
measure: Gingival index (Löe & Silness)
timeFrame: Clinical periodontal indices were recorded at the participants' first visit.
measure: Probing depth
timeFrame: Clinical periodontal indices were recorded at the participants' first visit.
measure: Attachment loss
timeFrame: Clinical periodontal indices were recorded at the participants' first visit.
measure: Bleeding on probing
timeFrame: Clinical periodontal indices were recorded at the participants' first visit.
measure: Determination of GCF and Saliva SOST level
timeFrame: 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.
measure: Determination of GCF and Saliva TWEAK level
timeFrame: 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.
measure: Determination of GCF RANKL level
timeFrame: 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.
measure: Determination of GCF OPG level
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Yeni̇mahalle
country: Turkey
facility: Ece Güner
state: Ankara
Study officials:
affiliation: Gazi University Faculty of Dentistry
name: Ece Güner, Phd
role: STUDY_CHAIR
affiliation: Gazi University
name: Gülay Tüter, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
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 2018 Dec 28.
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: 10.1155/2019/6195258. eCollection 2019.