Assessment of Salivary GM-CSF, MIP, and IL-1β Levels in Subjects With Varying Periodontal Conditions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorIzmir Katip Celebi University
About this trial
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. In recent publications, the role of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), Macrophage Inflammatory Protein (MIP)-1α and Interleukin (IL)-1β on chronic inflammatory diseases has been investigated. The aim of this study was to evaluate the levels of these cytokines in the saliva of healthy individuals with gingivitis and periodontitis.
All oral clinical parameters of 60 systemically healthy individuals (20 healthy, 20 with gingivitis and 20 with periodontitis) who applied to our clinic for routine periodontal control will be measured and saliva samples will be taken from the patients. GM-CSF, MIP-1α and IL-1β (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 in 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Systemically healthy participants.
At least twenty permanent teeth present in the oral cavity.
Non-smokers.
No medication for continuous use.
Disqualifiers
Any oral or systemic disease.
Regular use of systemic medications.
Pregnancy or lactation.
Received periodontal treatment within the last 6 months.
Trial population
Systemically healthy, non-smoking adults aged 18-70 years who have not used any medication in the last 6 months, are not pregnant or in the lactation period, and present for routine periodontal examination. Participants are categorized into periodontally healthy, gingivitis, and periodontitis groups based on clinical periodontal parameters
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Saliva obtaining
Diagnostic testThe patient was asked to sit upright and tilt his/her head forward to collect saliva samples. İn this way, unstimulated saliva was allowed to accumulate in the floor of the mouth. The accumulated saliva was collected in a sterile container. It was then transferred to a propylene tube. The tubes were centrifuged and the clear part at the top of the tube was taken with a sterile syringe and transferred to a different propylene tube with 0.5 ml in each tube. Tubes were stored at -80ºC until the day of analysis.
Saliva obtaining
Diagnostic testThe patient was asked to sit upright and tilt his/her head forward to collect saliva samples. İn this way, unstimulated saliva was allowed to accumulate in the floor of the mouth. The accumulated saliva was collected in a sterile container. It was then transferred to a propylene tube. The tubes were centrifuged and the clear part at the top of the tube was taken with a sterile syringe and transferred to a different propylene tube with 0.5 ml in each tube. Tubes were stored at -80ºC until the day of analysis.
Saliva obtaining
Diagnostic testThe patient was asked to sit upright and tilt his/her head forward to collect saliva samples. İn this way, unstimulated saliva was allowed to accumulate in the floor of the mouth. The accumulated saliva was collected in a sterile container. It was then transferred to a propylene tube. The tubes were centrifuged and the clear part at the top of the tube was taken with a sterile syringe and transferred to a different propylene tube with 0.5 ml in each tube. Tubes were stored at -80ºC until the day of analysis.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Healthy Periodontium1 intervention
Group B: Gingivitis1 intervention
Group C: Periodontitis1 intervention
Trial outcomes
Primary outcomes
1
Salivary level of GM- CSF
Amount of GM-CSF in human saliva
Time frame
24 hours after taking the clinical measurements at the first visit2
Salivary level of MIP-1α
Amount of MIP-1α in human saliva
Time frame
24 hours after taking the clinical measurements at the first visit3
Salivary level of IL-1β
Amount of IL-1β in human saliva
Time frame
24 hours after taking the clinical measurements at the first visitSecondary outcomes
1
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.
Time frame
At the initial visit.2
Periodontal Probing Depth
Distance between the gingival margin and sulcus/pocket floor
Time frame
At the initial visit.3
Clinical Attachment Level
Distance between the enamel-cement junction and the sulcus/base of the pocket.
Time frame
At the initial visit.4
Plaque Index
For 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 has completely filled the gingival groove and the interdental space is filled with soft debris.
Time frame
At the initial visit.Sponsors and contacts
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Source ClinicalTrials.gov