Evaluation of Salivary Interleukin-6, Interleukin-8 and LIGHT Protein Levels in Individuals With Different Periodontal Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Salivary LIGHT level
Study Overview
Brief 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 the current study, all oral clinical parameters of 60 systemically healthy individuals (20 healthy, 20 with gingivitis and 20 with periodontitis) who were admitted to the 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.
Detailed Description
The aim of this clinical study is to comparatively examine the levels of IL-6, IL-8 and LIGHT Protein in saliva samples obtained from periodontally healthy individuals with gingivitis and periodontitis who presented to the clinic for routine periodontal controls. In line with the results obtained; it is planned to determine the potential of these biochemical mediators to be used as a diagnostic marker in the diagnosis of periodontal disease.
Periodontitis is a multifactorial disease involving 10-15% of the world's adult population, developing due to microbial dental plaque and characterized by loss of clinical attachment and destruction of connective tissue and alveolar bone. If left untreated, it causes inflammation to penetrate into deeper tissues and alter bone homeostasis, leading to tooth loss.
Gingivitis is an inflammation of the gingiva that does not cause destruction in the surrounding tissues surrounding the tooth and is characterized by edema in the gums and bleeding in more than 10% of all areas in the mouth. According to the 2017 Classification of Periodontal Diseases, gingivitis is divided into two as dental plaque-related gingivitis and non-dental plaque-related gingivitis. Gingivitis is often painless and rarely spontaneous bleeding is observed and for these reasons, individuals may recognize the disease late. Therefore, early diagnosis of gingivitis is important to prevent the transformation of gingivitis into periodontitis characterized by progressive bone destruction and connective tissue destruction.
Studies have shown that there are more than 700 bacteria with the ability to colonize in the human oral cavity, but an average of 200 to 300 bacterial species in an individual's mouth. Among these bacteria, there are bacteria associated with gingival health, such as Porphyromonas gingivalis (Pg), Tannerella forsythensis (Tf), and Treponema denticola (Td), which are called red complex bacteria; Fusobacterium nucleatum (Fn) subspecies, Prevotella intermedia (Pi) and Aggregatibacter actinomycetemcomitans (Aa), which do not belong to any group, have been associated with active tissue destruction and periodontitis disease progression.
It has been shown that pathogenic bacteria affect the host immune response rather than direct inflammatory bone and connective tissue destruction. One of the important points in the pathogenesis of periodontal disease is cytokines, a member of the acquired immune system. Studies have shown that the amount of proinflammatory cytokines such as interleukin-6 (IL-6), IL-8, interleukin-1 (IL-1) tumor necrosis factor- α (TNF-α) increase in blood plasma, saliva and gingival groove fluid.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Systemically healthy participants.
- •At least twenty permanent teeth present in the oral cavity.
- •Non-smokers.
- •No medication for continuous use.
- •Not pregnant or breastfeeding.
Exclusion Criteria
- •Any oral or systemic disease.
- •Regular use of systemic medications.
- •Pregnancy or lactation.
- •Received periodontal treatment within the last 6 months.
- •Use of antibiotics, anti-inflammatory medications, or systemic corticosteroids in the last 6 months.
Outcomes
Primary Outcomes
Salivary LIGHT level
Time Frame: 24 hours after taking the clinical measurements at the first visit
Total amount of LIGHT protein in saliva
Salivary IL-8 level
Time Frame: 24 hours after taking the clinical measurements at the first visit
Total amount of interleukin-8 in saliva
Salivary IL-6 level
Time Frame: 24 hours after taking the clinical measurements at the first visit
total amount of interleukin-6 in saliva
Secondary Outcomes
- Clinical Attachment Level(during the the initial visit)
- Periodontal Probing Depth(during the the initial visit)
- Bleeding on probing(during the the initial visit)
- Plaque Index(during the the initial visit)
- Gingival Index(during the the initial visit)
Investigators
Doruk Sagsoz
Research Assistant of Periodontology
Izmir Katip Celebi University