Oxidative StressNCT06092853
Inflammatory Stress and Periodontal Tissue Destruction
An observational study of Oxidative Stress and Inflammation, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Metabolic syndrome and periodontitis are diseases that lower the quality of life and their incidence rates are increasing. Since both of these diseases are associated with systemic inflammation and insulin resistance, they may be comorbid. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Oxidative Stress, Inflammation
- What is being tested?
- Gingival crevicular fluid (GCF) and serum samples
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2022to 6 Jun 2023
- How long will I take part?
- 1 Week
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The sample size of the study was calculated using the G*Power program with an effect size of 0.4, 80% power, and a margin of error of 0.05.
Who may be able to join
- all participants were required to have at least 20 teeth and be between the ages of 20 and 65 years
Who cannot join
- Smokers, patients who had used antibiotics or anti-inflammatory and antioxidant drugs in the last 6 months, patients who were pregnant or lactating, those who had cancer or autoimmune diseases, and those who had undergone any periodontal treatment in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inflammatory Stress and Periodontal Tissue Destruction in Patients With Metabolic Syndrome and Periodontitis
Metabolic syndrome and periodontitis are diseases that lower the quality of life and their incidence rates are increasing. Since both of these diseases are associated with systemic inflammation and insulin resistance, they may be comorbid. The aim of this study was to evaluate the effect of interleukin-20 (IL-20) on periodontal destruction in individuals with metabolic syndrome while considering the relationship between metabolic syndrome and periodontitis.
This study included a total of 80 individuals who were systemically and periodontally healthy (CG, n=20), were systemically healthy and had periodontitis (PG, n=20), had metabolic syndrome and were periodontally healthy (MG, n=20), or had both metabolic syndrome and periodontitis (MPG, n=20). Gingival crevicular fluid (GCF) and serum samples were collected from all participants for biochemical analyses.
- Conditions
- Oxidative Stress, Inflammation
- Being tested
- Gingival crevicular fluid (GCF) and serum samples
- Keywords
- Metabolic syndrome, periodontitis, interleukin-20
- Medical subject headings
- Inflammation, Metabolic Syndrome, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival crevicular fluid (GCF) and serum samplesOther
Gingival crevicular fluid (GCF) and serum samples were collected from all participants for biochemical analyses
| Study group | Role | What they receive |
|---|---|---|
| systemically and periodontally healthy (CG) | Gingival crevicular fluid (GCF) and serum samples were collected from all participants for biochemical analyses. Receives: Other: Gingival crevicular fluid (GCF) and serum samples | |
| systemically healthy and periodontitis (PG) | Gingival crevicular fluid (GCF) and serum samples were collected from all participants for biochemical analyses Receives: Other: Gingival crevicular fluid (GCF) and serum samples | |
| Metabolic syndrome and periodontally healthy (MG) | Gingival crevicular fluid (GCF) and serum samples were collected from all participants for biochemical analyses Receives: Other: Gingival crevicular fluid (GCF) and serum samples | |
| Metabolic syndrome and periodontitis (MPG) | Gingival crevicular fluid (GCF) and serum samples were collected from all participants for biochemical analyses Receives: Other: Gingival crevicular fluid (GCF) and serum samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of gingival crevicular fluid (GCF) parameters
interleukin-20, RANKL, OPG values evaluated in GCF.
Measured: 1 year
concentration of serum parameters
interleukin-20, RANKL, OPG, MMP-8, TOS, TAS values evaluated in serum
Measured: 1 year
Secondary outcomes (2)
value of periodontal clinical parameters
plaque index, gingival index, bleeding on probing, Clinical attachment loss, probing pocket depth
Measured: 1 year
value of patients' clinical metabolic syndrome parameters
Body mass index (BMI), abdominal circumference, and HbA1c
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 posted23 Oct 2023
- Study start6 Jun 2022
- Primary completion6 Mar 2023
- Study completion6 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oxidative StressStudies 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
- Cross-sectional
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Recep Tayyip Erdogan University
- Responsible party
- Principal investigator, Hatice Yemenoğlu, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092853
- Sponsor's protocol ID
- Recep Tayyip ErdoganUniversity
- Other IDs
- RecepTayyipErdoganUniversity
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Senkal R, Yemenoglu H, Kose O, Karakas SM, Yilmaz A, Akyildiz K, Beder M, Bostan SA. The role of interleukin-20 on inflammatory stress and periodontal tissue destruction in patients with metabolic syndrome and periodontitis. BMC Oral Health. 2024 Nov 22;24(1):1423. doi: 10.1186/s12903-024-05224-3.
PubMed 39578819
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Stress and Periodontal Tissue Destruction in Patients With Metabolic Syndrome and Periodontitis
- ClinicalTrials.gov ID
- NCT06092853
- Acronym / sponsor ID
- Recep Tayyip ErdoganUniversity
- Conditions
- Oxidative Stress, Inflammation
- Keywords
- Metabolic syndrome, periodontitis, interleukin-20
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Collaborators
- Recep Tayyip Erdogan University
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 23 Oct 2023 (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.
Metabolic syndrome and periodontitis are diseases that lower the quality of life and their incidence rates are increasing. Since both of these diseases are associated with systemic inflammation and insulin resistance, they may be comorbid. The aim of this study was to evaluate the effect of interleukin-20 (IL-20) on periodontal destruction in individuals with metabolic syndrome while considering the relationship between metabolic syndrome and periodontitis.
This study included a total of 80 individuals who were systemically and periodontally healthy (CG, n=20), were systemically healthy and had periodontitis (PG, n=20), had metabolic syndrome and were periodontally healthy (MG, n=20), or had both metabolic syndrome and periodontitis (MPG, n=20). Gingival crevicular fluid (GCF) and serum samples were collected from all participants for biochemical analyses.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| systemically and periodontally healthy (CG) | – | Other: Gingival crevicular fluid (GCF) and serum samplesGingival crevicular fluid (GCF) and serum samples were collected from all participants for biochemical analyses. |
| systemically healthy and periodontitis (PG) | – | Other: Gingival crevicular fluid (GCF) and serum samplesGingival crevicular fluid (GCF) and serum samples were collected from all participants for biochemical analyses |
| Metabolic syndrome and periodontally healthy (MG) | – | Other: Gingival crevicular fluid (GCF) and serum samplesGingival crevicular fluid (GCF) and serum samples were collected from all participants for biochemical analyses |
| Metabolic syndrome and periodontitis (MPG) | – | Other: Gingival crevicular fluid (GCF) and serum samplesGingival crevicular fluid (GCF) and serum samples were collected from all participants for biochemical analyses |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sample size of the study was calculated using the G*Power program with an effect size of 0.4, 80% power, and a margin of error of 0.05.
Key inclusion criteria (1 listed)
- all participants were required to have at least 20 teeth and be between the ages of 20 and 65 years
Key exclusion criteria (1 listed)
- Smokers, patients who had used antibiotics or anti-inflammatory and antioxidant drugs in the last 6 months, patients who were pregnant or lactating, those who had cancer or autoimmune diseases, and those who had undergone any periodontal treatment in the last 6 months
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 |
|---|---|---|
| Gingival crevicular fluid (GCF) and serum samplesGingival crevicular fluid (GCF) and serum samples were collected from all participants for biochemical analyses | Other | Metabolic syndrome and periodontally healthy (MG), Metabolic syndrome and periodontitis (MPG), systemically and periodontally healthy (CG), systemically healthy and periodontitis (PG) |
Primary outcome
concentration of gingival crevicular fluid (GCF) parameters
Time frame: 1 year
interleukin-20, RANKL, OPG values evaluated in GCF.
concentration of serum parameters
Time frame: 1 year
interleukin-20, RANKL, OPG, MMP-8, TOS, TAS values evaluated in serum
2 secondary outcomes
value of periodontal clinical parameters
Time frame: 1 year
value of patients' clinical metabolic syndrome parameters
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 39578819Senkal R, Yemenoglu H, Kose O, Karakas SM, Yilmaz A, Akyildiz K, Beder M, Bostan SA. The role of interleukin-20 on inflammatory stress and periodontal tissue destruction in patients with metabolic syndrome and periodontitis. BMC Oral Health. 2024 Nov 22;24(1):1423. doi: 10.1186/s12903-024-05224-3.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Oxidative Stress and Inflammation, run by Recep Tayyip Erdogan University Training and Research Hospital 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: finished, as of the sponsor's last update on 23 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concentration of gingival crevicular fluid (GCF) parameters (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06092853, which also lists 1 linked publication.
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 23 Oct 2023.