PeriodontitisNCT06091800
Interleukin 20 and Periodontal Tisuue Destruction
An observational study of Periodontitis, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
Periodontitis is an inflammatory disease that causes destruction of periodontal tissues. IL-20, on the other hand, is known as a potent angiogenic, chemotactic, and pro-inflammatory cytokine associated with various chronic inflammatory disorders. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- biochemical analysis
- How many people
- 60 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study included individuals who applied to Recep Tayyip Erdogan University, Faculty of Dentistry, Department of Periodontology for treatment
Who may be able to join
- The following criteria were required for inclusion: being systemically healthy, not smoking, not using antibiotics or systemic corticosteroids within the previous three months, not being pregnant or nursing, not having a chronic inflammatory disease, not receiving periodontal therapy within the previous six months, and possessing at least 20 teeth
Who cannot join
- smoking, using antibiotics or systemic corticosteroids within the previous three months, pregnant, receiving periodontal therapy within the previous six months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of Levels of IL-20, TNF-α, IL1β/IL-10, RANKL/OPG and MMP8 in Serum and Gingival Crevicular Fluid (GCF) in Peridontally Healthy and Periodontitis Individuals
Periodontitis is an inflammatory disease that causes destruction of periodontal tissues. IL-20, on the other hand, is known as a potent angiogenic, chemotactic, and pro-inflammatory cytokine associated with various chronic inflammatory disorders. IL-20 has a significant role in the regulation of osteoclastogenesis and osteoblastogenesis. The aim of this study was to evaluate the effect of IL-20 on periodontal destruction.
In the study, a total of 60 participants were included, 30 of whom were systemically and periodontally healthy (control group) and 30 of whom were systemically healthy and had periodontitis (periodontitis group). GCF and serum samples were collected from the participants for biochemical analysis. ELISA method was used to determine IL-20, TNF-α, IL1β/IL-10, RANKL/OPG and MMP8 levels
- Conditions
- Periodontitis
- Being tested
- biochemical analysis
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biochemical analysisOther
GCF and serum samples were collected from the participants for biochemical analysis.
| Study group | Role | What they receive |
|---|---|---|
| control group (periodontally healthy) | no attachment loss, probing pocket depth ≤ 3 mm, minimal bleeding on probing ≤ 10%, and no radiographic bone loss Receives: Other: biochemical analysis | |
| periodontitis group | interdental clinical attachment level ≥ 5 mm, probing pocket depth ≥ 6 mm, radiographic bone loss extending to the middle or apical thirds of the root, mid-crest defect, and a history of ≤4 teeth loss of periodontal origin Receives: Other: biochemical analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of biochemical findings in gingival crevicular fluid (GCF)
IL-20, RANKL, OPG and RANKL/OPG values eveluated in GCF
Measured: june 2022-june 2023
concentration of biochemical findings in serum
IL-20, RANKL, OPG, RANKL/OPG, MMP-8, TNF-α, IL-1β, IL-10 and IL-1β/IL-10
Measured: 1 year
Secondary outcomes (2)
value of periodontal clinical parameters
plaque index (PI) (Silness \& Löe), gingival index (GI) (Silness \& Löe) and bleeding on probing index (BOP) of all natural teeth of the patients
Measured: 1 year
value of periodontal clinical parameters were measured in mm
probing pocket depth (PPD), clinical attachment loss (CAL) of all natural teeth of the patients
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 posted19 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.
- 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
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Yemenoglu, Recep Tayyip Erdogan University
- Investigators
- Yemenoglu, Principal investigator, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091800
- Sponsor's protocol ID
- RecepTayyip ErdoganUniversity
- Other IDs
- Recep Tayyip ErdoganUniversity
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Levels of IL-20, TNF-α, IL1β/IL-10, RANKL/OPG and MMP8 in Serum and Gingival Crevicular Fluid (GCF) in Peridontally Healthy and Periodontitis Individuals
- ClinicalTrials.gov ID
- NCT06091800
- Acronym / sponsor ID
- RecepTayyip ErdoganUniversity
- Conditions
- Periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 19 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.
Periodontitis is an inflammatory disease that causes destruction of periodontal tissues. IL-20, on the other hand, is known as a potent angiogenic, chemotactic, and pro-inflammatory cytokine associated with various chronic inflammatory disorders. IL-20 has a significant role in the regulation of osteoclastogenesis and osteoblastogenesis. The aim of this study was to evaluate the effect of IL-20 on periodontal destruction.
In the study, a total of 60 participants were included, 30 of whom were systemically and periodontally healthy (control group) and 30 of whom were systemically healthy and had periodontitis (periodontitis group). GCF and serum samples were collected from the participants for biochemical analysis. ELISA method was used to determine IL-20, TNF-α, IL1β/IL-10, RANKL/OPG and MMP8 levels
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group (periodontally healthy) | – | Other: biochemical analysisno attachment loss, probing pocket depth ≤ 3 mm, minimal bleeding on probing ≤ 10%, and no radiographic bone loss |
| periodontitis group | – | Other: biochemical analysisinterdental clinical attachment level ≥ 5 mm, probing pocket depth ≥ 6 mm, radiographic bone loss extending to the middle or apical thirds of the root, mid-crest defect, and a history of ≤4 teeth loss of periodontal origin |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study included individuals who applied to Recep Tayyip Erdogan University, Faculty of Dentistry, Department of Periodontology for treatment
Key inclusion criteria (1 listed)
- The following criteria were required for inclusion: being systemically healthy, not smoking, not using antibiotics or systemic corticosteroids within the previous three months, not being pregnant or nursing, not having a chronic inflammatory disease, not receiving periodontal therapy within the previous six months, and possessing at least 20 teeth
Key exclusion criteria (1 listed)
- smoking, using antibiotics or systemic corticosteroids within the previous three months, pregnant, receiving periodontal therapy within the previous six 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 |
|---|---|---|
| biochemical analysisGCF and serum samples were collected from the participants for biochemical analysis. | Other | control group (periodontally healthy), periodontitis group |
Primary outcome
concentration of biochemical findings in gingival crevicular fluid (GCF)
Time frame: june 2022-june 2023
IL-20, RANKL, OPG and RANKL/OPG values eveluated in GCF
concentration of biochemical findings in serum
Time frame: 1 year
IL-20, RANKL, OPG, RANKL/OPG, MMP-8, TNF-α, IL-1β, IL-10 and IL-1β/IL-10
2 secondary outcomes
value of periodontal clinical parameters
Time frame: 1 year
value of periodontal clinical parameters were measured in mm
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 19 Oct 2023.
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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.
Yemenoglu principal investigator
Recep Tayyip Erdogan 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 Recep Tayyip Erdogan 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: finished, as of the sponsor's last update on 19 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 biochemical findings in gingival crevicular fluid (GCF) (time frame: june 2022-june 2023). 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?
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 19 Oct 2023.