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

October 24, 2023 updated by: Ece Güner, Gazi University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ankara
      • Yeni̇mahalle, Ankara, Turkey
        • Ece Güner

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Diagnostic test: GCF and saliva analysis
ELISA
Non-smoker periodontitis
Diagnostic test: GCF and saliva analysis
ELISA
Smoker periodontitis
Diagnostic test: GCF and saliva analysis
ELISA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque index (Silness & Löe )
Time Frame: Clinical periodontal indices were recorded at the participants' first visit.
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)
Time Frame: Clinical periodontal indices were recorded at the participants' first visit.
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
Time Frame: Clinical periodontal indices were recorded at the participants' first visit.
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
Time Frame: Clinical periodontal indices were recorded at the participants' first visit.
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
Time Frame: Clinical periodontal indices were recorded at the participants' first visit.
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
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Investigators

  • Study Chair: Ece Güner, Phd, Gazi University Faculty of Dentistry
  • Study Director: Gülay Tüter, Professor, Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

September 4, 2023

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

October 24, 2023

First Posted (Actual)

October 27, 2023

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6362

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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