Clinical trial NCT06523205: Relationships Between Tenascin C, Smoking and Periodontal Status
Official title: Evaluation of the Relationships Between Salivary Tenascin C ,IL-4, IL-6, and IL-1β Levels, Smoking and Periodontal Status
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Periodontitis
Smoking
Periodontal Diseases
Keywords: periodontitis
cytokines
saliva
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 100
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: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is planned to be conducted with 100 individuals aged between 18 and 65 who apply to the Department of Periodontology, Faculty of Dentistry, Necmettin Erbakan University, for various reasons. The eligibility of individuals to be included will be evaluated by Assistant Professor Dr. Osman BABAYIGIT at the Periodontology Clinic of NEU Faculty of Dentistry.

Brief summary: The goal of this observational study is to determine if there is a relationship between different periodontal conditions (gingival healthy, stage 2 grade B, stage 2 grade C, stage 3 grade B, stage 3 grade C) and the levels of tenascin C, IL-1 beta, IL-4, and IL-6 in saliva samples from smokers and non-smokers. The main questions it aims to answer are:

Is there a difference in the levels of tenascin C, IL-1 beta, IL-4, and IL-6 between smokers and non-smokers with different periodontal conditions? Do these biomarkers correlate with the severity and grade of periodontal disease?

Researchers will compare the saliva samples from smokers and non-smokers across the different periodontal conditions to see if there are significant differences in the biomarker levels. Participants will:

Provide saliva samples. Be categorized based on their smoking status and periodontal condition.


Eligibility criteria: Inclusion Criteria:

* The periodontitis groups (Non-smoking and smoking) in the study will include systemically healthy patients who are clinically diagnosed with Stage II and III, generalized, Grade B, C periodontitis based on the consensus report of the 2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions.
* Agreeing to participate in the study

Exclusion Criteria:

* use of oral contraceptive drugs
* use of antibiotics, immunosuppressants, or drug therapies in the last 6 months before the study;
* history of excessive alcohol use;
* pregnancy or breastfeeding status;
* periodontal treatment during the last 6 months before the study.
* Not agreeing to participate in the study
* Not meeting the inclusion criteria

Primary outcomes:
measure: 1.Periodontal clinical parameters (plaque index (PI) and gingival index (GI))
timeFrame: baseline
measure: Periodontal clinical parameters (percentage bleeding on probing (BOP))
timeFrame: baseline
measure: Periodontal clinical parameters (Clinical Attachment Level (CAL) and Probing Pocket Depth (PPD))
timeFrame: baseline
measure: Levels of Tenascin C, IL-1β, IL-4 and IL-6 saliva samples
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: