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

Sponsor
Gazi University (Other)
Overall Status
Completed
CT.gov ID
NCT06103578
Collaborator
(none)
78
1
21.1
3.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: GCF and saliva analysis

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
78 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
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
Actual Study Start Date :
Dec 1, 2021
Actual Primary Completion Date :
Sep 30, 2022
Actual Study Completion Date :
Sep 4, 2023

Arms and Interventions

Arm Intervention/Treatment
Non-smoker periodontitis

Diagnostic Test: GCF and saliva analysis
ELISA

Smoker periodontitis

Diagnostic Test: GCF and saliva analysis
ELISA

Control

Diagnostic Test: GCF and saliva analysis
ELISA

Outcome Measures

Primary Outcome Measures

  1. Plaque index (Silness & Löe ) [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.

  2. Gingival index (Löe & Silness) [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.

  3. Probing depth [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.

  4. Attachment loss [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.

  5. Bleeding on probing [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.

  6. Determination of GCF and Saliva SOST level [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.

  7. Determination of GCF and Saliva TWEAK level [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.

  8. Determination of GCF RANKL level [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.

  9. Determination of GCF OPG level [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ece Güner Yeni̇mahalle Ankara Turkey

Sponsors and Collaborators

  • Gazi University

Investigators

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

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Ece Güner, Assistant researcher, Gazi University
ClinicalTrials.gov Identifier:
NCT06103578
Other Study ID Numbers:
  • 6362
First Posted:
Oct 27, 2023
Last Update Posted:
Oct 27, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ece Güner, Assistant researcher, Gazi University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 27, 2023