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NCT Number: NCT06103578

Evaluation of SOST, TWEAK, RANKL, 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.

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Key information

Conditions

Periodontitis Behavior Mouth Diseases Periodontal Diseases Smoking Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ece Güner

Yenimahalle, Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GCF and saliva analysis

Diagnostic Test

ELISA

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Oct 27, 2023
Registry last updated
Oct 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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