PeriodontitisNCT04647123
Evaluation of Biomarker Levels in Blood, Saliva and Gingival Fluid in Periodontitis
An observational study of Periodontitis, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontitis
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Mar 2021
- How long will I take part?
- 15 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Systemically healhty ,non-smokers,non-pregnants will be included in the study
Who may be able to join
- Systemically healhty non-smokers non-pregnants -
Who cannot join
- Patients with systemic disease smokers pregnants
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Van yuzuncu yil university
Van, 65080
Hacer Sahin aydınyurt, Assoc. Prof., 05304589710, hacersahinay@gmail.com
Cem Taskin, Phd
About this study
Official title: Evaluation of Ischemic Modified Albumin, Catalase, Reduced Glutathione, Malondialdehyde, Adenosine Deaminase Levels in Blood, Saliva and Gingival Fluid in Periodontitis
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.
Read the 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.
- Conditions
- Periodontitis
- Being tested
- No intervention was applied to the groups the samples will be collected in terms of the diagnosis (hopeless, periodontitis, gingivitis, healthy)
- Keywords
- periodontitis, catalase, malondialdehide
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention was applied to the groups the samples will be collected in terms of the diagnosis (hopeless, periodontitis, gingivitis, healthy)Other
No intervention was applied to the groups the samples will be collected in terms of the diagnosis (hopeless, periodontitis, gingivitis, healthy)
| Study group | Role | What they receive |
|---|---|---|
| Hopeless teeth | The teeth that can not be treated periodontally and who are desperate for extraction will be included in this group. Receives: Other: 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. Receives: Other: 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. Receives: Other: 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. Receives: Other: No intervention was applied to the groups the samples will be collected in terms of the diagnosis (hopeless, periodontitis, gingivitis, healthy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
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)
Measured: 1 year
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.
Measured: 1 year
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)
Measured: 1 year
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start1 Jan 2020
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 15 Months
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hacer Sahin Aydinyurt, Yuzuncu Yil University
- Investigators
- hacer sahin aydınyurtt, assoc. prof, Principal investigator, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647123
- Sponsor's protocol ID
- : 06.06.2018/09
- Status last verified
- Nov 2020
- First submitted
- 17 Nov 2020
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ischemic Modified Albumin, Catalase, Reduced Glutathione, Malondialdehyde, Adenosine Deaminase Levels in Blood, Saliva and Gingival Fluid in Periodontitis
- ClinicalTrials.gov ID
- NCT04647123
- Acronym / sponsor ID
- : 06.06.2018/09
- Conditions
- Periodontitis
- Keywords
- periodontitis, catalase, malondialdehide
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 30 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 15 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hopeless teeth | – | Other: No intervention was applied to the groups the samples will be collected in terms of the diagnosis (hopeless, periodontitis, gingivitis, healthy)The teeth that can not be treated periodontally and who are desperate for extraction will be included in this group. |
| Periodontitis | – | Other: No intervention was applied to the groups the samples will be collected in terms of the diagnosis (hopeless, periodontitis, gingivitis, healthy)Teeth diagnosed with periodontitis will be included in this group. |
| Gingivitis | – | Other: No intervention was applied to the groups the samples will be collected in terms of the diagnosis (hopeless, periodontitis, gingivitis, healthy)Teeth diagnosed with gingivitis will be included in this group. |
| Healthy | – | Other: No intervention was applied to the groups the samples will be collected in terms of the diagnosis (hopeless, periodontitis, gingivitis, healthy)Teeth diagnosed with helthy will be included in this group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Systemically healhty ,non-smokers,non-pregnants will be included in the study
Key inclusion criteria (1 listed)
- Systemically healhty non-smokers non-pregnants -
Key exclusion criteria (1 listed)
- Patients with systemic disease smokers pregnants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Other | Gingivitis, Healthy, Hopeless teeth, Periodontitis |
Primary outcome
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.
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)
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.
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)
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hacer sahin aydınyurtt, assoc. prof principal investigator
Yuzuncu Yil University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hacer sahin aydınyurt (05304589710, hacersahinay@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adenosine deaminase (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2020.