- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04647123
Evaluation of Biomarker Levels in Blood, Saliva and Gingival Fluid in Periodontitis
Evaluation of Ischemic Modified Albumin, Catalase, Reduced Glutathione, Malondialdehyde, Adenosine Deaminase Levels in Blood, Saliva and Gingival Fluid in Periodontitis
Study Overview
Status
Conditions
Detailed Description
The research methodology was approved by the Van Yuzuncu Yıl University Clinical Research Ethics Committee. (Decision number: 06.06.2018/09).
The aim of this study is to compare Ischemia-modified albumin (IMA), malondialdehyde (MDA), Catalase (CAT), Glutathione (GSH) and Adenosine deaminase (ADA) levels in gingival crevicular fluid, serum and saliva of periodontally hopeless, periodontitis and gingivitis teeth with healthy control groups.
In this study, 25 periodontally healthy individuals (control group) and 25 individuals with various levels of periodontal disease in different teeth will be included.
Gingival crevicular fluid, saliva and blood samples will be taken from patients with periodontally healthy teeth without any treatment.
In patients diagnosed with periodontal disease, teeth will be divided into 3 subgroups as hopeless, periodontitis and gingivitis. In patients with a diagnosis of periodontal disease, saliva and blood samples will be taken twice, before and after the training of scaling and root planing, desperate tooth extraction, oral hygiene motivation.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
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Van, Turkey, 65080
- Recruiting
- Van Yüzüncü Yil University
-
Contact:
- Hacer Sahin aydınyurt, Assoc. Prof.
- Phone Number: 05304589710
- Email: hacersahinay@gmail.com
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Sub-Investigator:
- Cem Taskin, Phd
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Systemically healhty non-smokers non-pregnants -
Exclusion Criteria:
- Patients with systemic disease smokers pregnants
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Hopeless teeth
The teeth that can not be treated periodontally and who are desperate for extraction will be included in this group.
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No intervention was applied to the groups the samples will be collected in terms of the diagnosis (hopeless, periodontitis, gingivitis, healthy)
|
|
Periodontitis
Teeth diagnosed with periodontitis will be included in this group.
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No intervention was applied to the groups the samples will be collected in terms of the diagnosis (hopeless, periodontitis, gingivitis, healthy)
|
|
Gingivitis
Teeth diagnosed with gingivitis will be included in this group.
|
No intervention was applied to the groups the samples will be collected in terms of the diagnosis (hopeless, periodontitis, gingivitis, healthy)
|
|
Healthy
Teeth diagnosed with helthy will be included in this group.
|
No intervention was applied to the groups the samples will be collected in terms of the diagnosis (hopeless, periodontitis, gingivitis, healthy)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
adenosine deaminase
Time Frame: 1 year
|
Adenosine deaminase (ADA) is an enzyme involved in proliferation and differentiation.
Although ADA has been investigated in different inflammatory and infectious diseases and has been defined as an immunoenzyme biomarker, its role in periodontitis has not been fully elucidated yet.
|
1 year
|
|
catalase
Time Frame: 1 year
|
Catalase (CAT) decomposes H2O2 catalyzed by superoxide dismutase (SOD) into H2O and O2.
(13) It is stated in the literature that CAT, SOD and total oxidant state are important biomarkers that can be used in the diagnosis of periodontal disease and evaluation of treatment results.
(14)
|
1 year
|
|
Ischemia-modified albumin
Time Frame: 1 year
|
Ischemia-modified albumin (IMA) is suggested as an oxidative stress marker and an indicator of inflammatory diseases.
It has been reported in the literature that the serum IMA level increases significantly in the case of periodontal disease and decreases after treatment.
In this respect, it has been stated that IMA can be an indicator of systemic inflammation caused by periodontal disease.
|
1 year
|
|
malondialdehide
Time Frame: 1 year
|
In periodontal disease, an increase in reactive oxygen species and a decrease in antioxidant activity are observed because this disease is thought to be associated with an imbalance between antioxidants and oxidants.
(8) Lipid peroxidation is a result of periodontitis.
Free radicals that lead to the production of toxic and reactive aldehyde metabolites such as malondialdehyde (MDA) cause lipid peroxidation.
(9) It is among the information in the literature that MDA levels increase in the case of periodontal inflammation and that MDA can be considered as an oxidative stress marker for periodontitis.
(10-12)
|
1 year
|
|
glutathione
Time Frame: 1 year
|
Glutathione (GSH) acts as a coenzyme in the oxidation-reduction process.
(15) GSH is a critical redox regulator and important for the health of peridontium
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: hacer sahin aydınyurtt, assoc. prof, Van Yüzüncü Yil University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- : 06.06.2018/09
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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