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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04647123
Other study ID # : 06.06.2018/09
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date March 1, 2021

Study information

Verified date November 2020
Source Yuzuncu Yil University
Contact Hacer sahin aydinyurt
Phone 05304589710
Email hacersahinay@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim of this study was to compare IMA, MDA, CAT, GSH and ADA levels in gingival crevicular fluid, serum and saliva of periodontally hopeless, periodontitis and gingivitis teeth with healthy control groups.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date March 1, 2021
Est. primary completion date February 1, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: Systemically healhty non-smokers non-pregnants - Exclusion Criteria: - Patients with systemic disease smokers pregnants

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention was applied to the groups the samples will be collected in terms of the diagnosis (hopeless, periodontitis, gingivitis, healthy)
No intervention was applied to the groups the samples will be collected in terms of the diagnosis (hopeless, periodontitis, gingivitis, healthy)

Locations

Country Name City State
Turkey Van yuzuncu yil university Van

Sponsors (1)

Lead Sponsor Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary adenosine deaminase 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
Primary catalase 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
Primary Ischemia-modified albumin 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
Primary malondialdehide 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
Primary glutathione 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
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