Evaluation of Salivary Biomarker Levels in Individuals with Different Periodontal Conditions
NCT Number: NCT06558136
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Periodontitis|Gingivitis|Periodontal Health
Sponsor: Izmir Katip Celebi University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08-01
Completion Date: 2025-05-01

Summary:
In order to determine the pathogenesis of chronic inflammatory diseases, the levels of various cytokines are examined in tissues and fluids taken from the body. Recent publications have investigated the role of Interleukin-6 (IL-6), Interleukin-8 (IL-8) and LIGHT in chronic inflammatory diseases. The aim of this study was to evaluate the levels of these cytokines in the saliva of healthy individuals with gingivitis and periodontitis and to investigate whether they are reliable biomarkers for the diagnosis of periodontitis.

In our study, all oral clinical parameters of 60 systemically healthy individuals (20 healthy, 20 with gingivitis and 20 with periodontitis) who were admitted to our clinic for routine periodontal control will be measured and saliva samples will be taken from the patients. IL-6, IL-8 and LIGHT (biomarkers emphasizing inflammation in saliva samples) will be determined by enzyme-linked immunoassay (ELISA). Then, statistical analyses will be performed to interpret the difference in cytokine levels between the groups and the relationship between these cytokines and clinical parameters.

Possible significant differences between cytokine levels will reveal that these proteins and enzymes can be utilized as a diagnostic tool in periodontal diseases, to distinguish periodontal disease status from healthy, or as a guide for treatments.

Primary Outcome Measures: Salivary LIGHT level, Total amount of LIGHT protein in saliva, 24 hours after taking the clinical measurements at the first visit|Salivary IL-6 level, total amount of interleukin-6 in saliva, 24 hours after taking the clinical measurements at the first visit|Salivary IL-8 level, Total amount of interleukin-8 in saliva, 24 hours after taking the clinical measurements at the first visit
Secondary Outcome Measures: Periodontal Probing Depth, With the help of a periodontal probe, the distance between the gingival margin and the sulcus/pocket base will be measured from six points of the tooth: mesiobuccal, midbuccal, distobuccal, mesiopalatinal/lingual, mid buccal/palatinal and distobuccal/palatinal. During the measurement, care will be taken to ensure that the probe is parallel to the long axis of the tooth and that excessive force is not applied. The values will be summed and divided by 6 to calculate the average SCD for each patient., during the the initial visit|Clinical Attachment Level, With the help of a periodontal probe, the distance between the enamel-cement border and the sulcus/pocket base will be measured at six points of the tooth: mesiobuccal, midbuccal, distobuccal, mesiopalatinal/lingual, mid buccal/palatinal and distobuccal/palatinal. The values will be summed and divided by 6 to calculate the average amount of clinical attachment level for each patient., during the the initial visit|Plaque Index, For Silness\&Löe plaque index measurement, values will be obtained from four surfaces of each tooth: mesial, distal, vestibular and palatinal. The values will be summed and divided by four to determine the PI score for each tooth. Scoring will be done as follows; 0: No bacterial plaque on the gingival area of the tooth surface.

1. No bacterial plaque is visible on the surface of the tooth by eye, but after probing, bacterial plaque is observed at the tip of the probe.
2. The gingival area is covered with a thin to moderate amount of bacterial plaque, which is visible by eye.
3. There is a large amount of soft debris, the thickness of which completely fills the gingival groove and the interdental space is filled with soft debris., during the the initial visit|Gingival Index, According to Löe\&Silness gingival index; vestibule, lingual, mesial and distal surfaces of all teeth will be examined. The values will be summed and divided by four to determine the GI score for each tooth.

0: Healthy gingiva.

1. Mild inflammation, mild discoloration and edema but no bleeding after probing.
2. Moderate inflammation, edema, redness and brightness, bleeding on probing.
3. Severe inflammation and redness, edema, ulceration and tendency to spontaneous bleeding., during the the initial visit|Bleeding on probing, The following index criteria will be used to determine the degree of inflammation in the soft tissue surrounding the vestibular, lingual, mesial and distal surfaces of all teeth. The number of positive (+) scoring areas on the examined surfaces will be calculated as a percentage of the total number of examined areas.

(-): No bleeding when the periodontal probe is passed along the gingival sulcus. (+): Bleeding is present at the gingival margin., during the the initial visit