- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05417061
Serum and Saliva Sirtuin 6, Lipoxin A4, Caspase8 Levels in Correlation With Periodontal Status in Severe Periodontitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Fatih
-
Istanbul, Fatih, Turkey, 34083
- Istanbul Medipol University, School of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- systemically healthy
- clinical diagnosis of periodontitis
- clinical diagnosis of periodontal health
Exclusion Criteria:
- history of regular use of systemic antibiotics anti-inflammatory, or antioxidant drugs (previous 3 months)
- nonsurgical periodontal treatment (previous 6 months)
- surgical periodontal treatment (previous 12 months)
- presence of<10 teeth
- current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy)
- diabetes
- diagnosis of rheumatoid arthritis
- pregnancy
- lactating
- smoking
- excessive alcohol consumption.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Saliva and serum collection of patients and samples molecules analysis
|
Saliva were collected to analyze the selected markers as unstimulated samples during the early hours of the day. The saliva was centrifuged and then transferred into Eppendorf tubes. Venous puncture was performed after saliva collection and 10 mL of blood samples were collected by qualified staff (MFD) from each participant. Saliva and serum were then stored at -80 °C until analysis. |
|
Experimental: Salivary and serum SIRT6, LPXA4 and CASP8 observation
Saliva and serum samples obtained for each patient were used for cytokine analysis. Prepared samples were analyzed for Lipoxin A4 (LXA4), Caspase 8 (CASP8) and Sirtuin-6 (SIRT6) using commercial ELISA kits (Elabscience, Houston, Texas, USA and Bioaasay Technology Laboratory (BT-Lab), Shanghai, China, respectively) according to the manufacturer's instructions. The detection limits of ELISA kits were 0.78 - 50ng/ml for LXA4, 0.16 - 10ng/ml for CASP8 and 0.1- 40 ng/ml for SIRT6. |
Saliva were collected to analyze the selected markers as unstimulated samples during the early hours of the day. The saliva was centrifuged and then transferred into Eppendorf tubes. Venous puncture was performed after saliva collection and 10 mL of blood samples were collected by qualified staff (MFD) from each participant. Saliva and serum were then stored at -80 °C until analysis. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pocket probing depth
Time Frame: 6 months
|
Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe.
|
6 months
|
|
Clinical attachment level
Time Frame: 6 months
|
Clinical attachment level (or loss, CAL) is a more accurate indicator of the periodontal support around a tooth than probing depth alone. CAL is measured from a fixed point on the tooth that does not change, the CEJ. To calculate CAL, two measurements are needed: distance from the gingival margin to the CEJ and probing depth. In recession: probing depth (+) gingival margin to the CEJ (add). In tissue overgrowth: probing depth (-) gingival margin to the CEJ (subtract) |
6 months
|
|
Bleeding on probing
Time Frame: 6 months
|
referring to bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus, or interface between the gingiva and a tooth.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Saliva and serum samples processing and analyses
Time Frame: 2 months
|
Saliva and serum samples obtained for each patient were used for cytokine analysis. Prepared samples were analyzed for Lipoxin A4 (LXA4), Caspase 8 (CASP8) and Sirtuin-6 (SIRT6) using commercial ELISA kits (Elabscience, Houston, Texas, USA and Bioaasay Technology Laboratory (BT-Lab), Shanghai, China, respectively) according to the manufacturer's instructions. |
2 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 138
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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