BiomarkersNCT07171151
Detection of Disease Marker Factors in Cyst Fluid
An observational study of Biomarkers, run by Harran University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this observational study is to examine the cyst fluid obtained after a puncture procedure performed for cyst diagnosis in participants with cystic lesions on clinical and radiological examination.The main question it aims to answer is: What is the exact mechanism of formation of odontogenic cysts?… Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Biomarkers
- What is being tested?
- cyst fluid examination
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2025to May 2026
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study group will consist of individuals aged 12-80 with cystic lesions who agree to participate in the study themselves and with their families (if children), and who are not pregnant or breastfeeding.
Who may be able to join
- Individuals diagnosed with cysts
- Individuals who are not pregnant or breastfeeding
- Individuals who agree to sign the informed consent form
Who cannot join
- Systemically ill individuals who are contraindicated for surgery.
- Individuals who do not wish to sign the informed consent form.
- Individuals who are pregnant, breastfeeding, or using oral contraceptives will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Harran University, Faculty of Dentistry
Sanliurfa
mine alkaya karagoz, 905365417606, minekaragoz@harran.edu.tr
hande has elci, 905076577647, handehaselci@harran.edu.tr
About this study
Official title: Measurement of MMP-8, MMP-9, RANKL, MIP-1alpha in Biopsy Samples From Odontogenic Cyst Patients
The purpose of this observational study is to examine the cyst fluid obtained after a puncture procedure performed for cyst diagnosis in participants with cystic lesions on clinical and radiological examination.The main question it aims to answer is:
- What is the exact mechanism of formation of odontogenic cysts?
Biomarkers in the cyst fluid obtained after a puncture procedure performed as part of the diagnosis and treatment process of odontogenic cysts will be examined. The aim of this study is to gain insight into cyst pathology by examining the levels of biomarkers in odontogenic cyst fluid.
Read the detailed description
Patients with cystic lesions who apply to Harran University Oral and Maxillofacial Surgery between August 2025 and December 2025 will be included in the study. Approximately 25 patients are planned to be included in the study. Informed consent will be obtained from patients included in the study.
Participants will not undergo any procedures outside of the routine for the study. Aspiration will be performed before cyst enucleation/marsupialization. Later, excisional/incisional biopsies will also be performed during enucleation and marsupialization.The cyst fluid obtained during the puncture will be collected in a tube and centrifuged at 3000 rpm for 20 minutes at 4 degrees Celsius. The Eppendorf tubes will be stored at -80 °C until the clear liquid remaining above is taken and examined, without removing the particles that have settled at the bottom of the tube. The biochemical parameters of the cyst fluid obtained from the study participants will be analyzed using the ELISA method. MMP-8, MMP-9, RANKL, and MIP1alpha will be analyzed using commercially available ELISA kits, following the manufacturer's instructions.
While the concentration levels of MMP-8, MMP-9, RANKL, and MIP-1alpha are dependent variables, the cyst type, its inflammatory or developmental origin, and other clinical features are independent variables.The data will be calculated using the SPSS program. The normality of the data will be examined using the Shapiro-Wilk and Kolmogorov tests, and outliers will be calculated using boxplots and Z-scores. When comparing variables with a normal distribution in two independent groups, the "independent samples t-test" will be used; if there is no normal distribution, the Mann-Whitney U test will be used. If three or more distributions are normal, "one-way ANOVA" will be used; if normal distribution is not found, the Kruskal-Wallis test will be used. If the data is normally distributed, the Pearson correlation coefficient will be used for correlation analysis; otherwise, the Spearman correlation coefficient will be used. Boxplots will be used to show the distribution of biomarker levels by cyst type, Scatter Plots will be used to visualize correlations between biomarkers, and Bar Graphs will be used to compare mean biomarker levels by cyst type.
The underlying mechanism of odontogenic tumors and cysts is not yet clear. In the literature review, no studies were found on MMP-8 in odontogenic tumors, and only a few studies were found on RANKL and MIP-1alpha. Therefore, the aim of this study is to gain insight into cyst pathology by examining the levels of biomarkers in odontogenic cyst fluid. The secondary objective of this study is to examine the correlation between markers measured by cyst type.
- Conditions
- Biomarkers
- Being tested
- cyst fluid examination
- Keywords
- odontogenic cysts, biomarkers, MMP-8, MIP-1alfa
- Medical subject headings
- Odontogenic Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyst fluid examinationOther
Participants will not undergo any procedures outside of the routine for the study. The cyst fluid obtained during the puncture will be collected in a tube and centrifuged at 3000 rpm for 20 minutes at 4 degrees Celsius. The Eppendorf tubes will be stored at -80 °C until the clear liquid remaining above is taken and examined, without removing the particles that have settled at the bottom of the tube. The biochemical parameters of the cyst fluid obtained from the study participants will be analyzed using the ELISA method. MMP-8, MMP-9, RANKL, and MIP1alpha will be analyzed using commercially available ELISA kits, following the manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| individuals with odontogenic cysts | The cyst fluid obtained during the puncture will be collected in a tube and centrifuged. The clear liquid remaining on top will be transferred to an Eppendorf tube and stored at -80 degrees. After all samples are collected, they will be analyzed using the ELISA method. Receives: Other: cyst fluid examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMP-8 concentration level in cyst fluid
Cyst fluids aspirated during the puncture will be centrifuged using a centrifuge and stored at -80 degrees Celsius in Eppendorf tubes until examined. After all samples are collected, the MMP-8 concentration level will be measured.
Measured: through study completion, an average of 6 months
MMP-9 concentration level in cyst fluid
Cyst fluids aspirated during the puncture will be centrifuged using a centrifuge and stored at -80 degrees Celsius in Eppendorf tubes until examined. After all samples are collected, the MMP-9 concentration level will be measured.
Measured: through study completion, an average of 6 months
RANKL concentration level in cyst fluid
Cyst fluids aspirated during the puncture will be centrifuged using a centrifuge and stored at -80 degrees Celsius in Eppendorf tubes until examined. After all samples are collected, the RANKL concentration level will be measured.
Measured: through study completion, an average of 6 months
MIP-1alpha concentration level in cyst fluid
Cyst fluids aspirated during the puncture will be centrifuged using a centrifuge and stored at -80 degrees Celsius in Eppendorf tubes until examined. After all samples are collected, the MIP-1alpha concentration level will be measured.
Measured: through study completion, an average of 6 months
Secondary outcomes (1)
Correlation between the type of cyst and the measured markers
After measuring the concentration levels of the MMP-8, MMP-9, RANKL, and MIP-1alpha biomarkers in the cyst fluid, the results will be compared with the subsequent biopsy results to examine their correlation with the type and origin of the cyst.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start25 Aug 2025
- Primary completionDec 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiomarkersStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mine alkaya karagoz, Harran University
- Investigators
- hande has elci, Principal investigator, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171151
- Sponsor's protocol ID
- HRU/25.11.54
- Status last verified
- Sep 2025
- First submitted
- 25 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of MMP-8, MMP-9, RANKL, MIP-1alpha in Biopsy Samples From Odontogenic Cyst Patients
- ClinicalTrials.gov ID
- NCT07171151
- Acronym / sponsor ID
- HRU/25.11.54
- Conditions
- Biomarkers
- Keywords
- odontogenic cysts, biomarkers, MMP-8, MIP-1alfa
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 12 Sep 2025 (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 purpose of this observational study is to examine the cyst fluid obtained after a puncture procedure performed for cyst diagnosis in participants with cystic lesions on clinical and radiological examination.The main question it aims to answer is:
- What is the exact mechanism of formation of odontogenic cysts?
Biomarkers in the cyst fluid obtained after a puncture procedure performed as part of the diagnosis and treatment process of odontogenic cysts will be examined. The aim of this study is to gain insight into cyst pathology by examining the levels of biomarkers in odontogenic cyst fluid.
Detailed description
Patients with cystic lesions who apply to Harran University Oral and Maxillofacial Surgery between August 2025 and December 2025 will be included in the study. Approximately 25 patients are planned to be included in the study. Informed consent will be obtained from patients included in the study.
Participants will not undergo any procedures outside of the routine for the study. Aspiration will be performed before cyst enucleation/marsupialization. Later, excisional/incisional biopsies will also be performed during enucleation and marsupialization.The cyst fluid obtained during the puncture will be collected in a tube and centrifuged at 3000 rpm for 20 minutes at 4 degrees Celsius. The Eppendorf tubes will be stored at -80 °C until the clear liquid remaining above is taken and examined, without removing the particles that have settled at the bottom of the tube. The biochemical parameters of the cyst fluid obtained from the study participants will be analyzed using the ELISA method. MMP-8, MMP-9, RANKL, and MIP1alpha will be analyzed using commercially available ELISA kits, following the manufacturer's instructions.
While the concentration levels of MMP-8, MMP-9, RANKL, and MIP-1alpha are dependent variables, the cyst type, its inflammatory or developmental origin, and other clinical features are independent variables.The data will be calculated using the SPSS program. The normality of the data will be examined using the Shapiro-Wilk and Kolmogorov tests, and outliers will be calculated using boxplots and Z-scores. When comparing variables with a normal distribution in two independent groups, the "independent samples t-test" will be used; if there is no normal distribution, the Mann-Whitney U test will be used. If three or more distributions are normal, "one-way ANOVA" will be used; if normal distribution is not found, the Kruskal-Wallis test will be used. If the data is normally distributed, the Pearson correlation coefficient will be used for correlation analysis; otherwise, the Spearman correlation coefficient will be used. Boxplots will be used to show the distribution of biomarker levels by cyst type, Scatter Plots will be used to visualize correlations between biomarkers, and Bar Graphs will be used to compare mean biomarker levels by cyst type.
The underlying mechanism of odontogenic tumors and cysts is not yet clear. In the literature review, no studies were found on MMP-8 in odontogenic tumors, and only a few studies were found on RANKL and MIP-1alpha. Therefore, the aim of this study is to gain insight into cyst pathology by examining the levels of biomarkers in odontogenic cyst fluid. The secondary objective of this study is to examine the correlation between markers measured by cyst type.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| individuals with odontogenic cysts | – | Other: cyst fluid examinationThe cyst fluid obtained during the puncture will be collected in a tube and centrifuged. The clear liquid remaining on top will be transferred to an Eppendorf tube and stored at -80 degrees. After all samples are collected, they will be analyzed using the ELISA method. |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study group will consist of individuals aged 12-80 with cystic lesions who agree to participate in the study themselves and with their families (if children), and who are not pregnant or breastfeeding.
Key inclusion criteria (3 listed)
- Individuals diagnosed with cysts
- Individuals who are not pregnant or breastfeeding
- Individuals who agree to sign the informed consent form
Key exclusion criteria (3 listed)
- Systemically ill individuals who are contraindicated for surgery.
- Individuals who do not wish to sign the informed consent form.
- Individuals who are pregnant, breastfeeding, or using oral contraceptives will be excluded.
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 |
|---|---|---|
| cyst fluid examinationParticipants will not undergo any procedures outside of the routine for the study. The cyst fluid obtained during the puncture will be collected in a tube and centrifuged at 3000 rpm for 20 minutes at 4 degrees Celsius. The Eppendorf tubes will be stored at -80 °C until the clear liquid remaining above is taken and examined, without removing the particles that have settled at the bottom of the tube. The biochemical parameters of the cyst fluid obtained from the study participants will be analyzed using the ELISA method. MMP-8, MMP-9, RANKL, and MIP1alpha will be analyzed using commercially available ELISA kits, following the manufacturer's instructions. | Other | individuals with odontogenic cysts |
Primary outcome
MMP-8 concentration level in cyst fluid
Time frame: through study completion, an average of 6 months
Cyst fluids aspirated during the puncture will be centrifuged using a centrifuge and stored at -80 degrees Celsius in Eppendorf tubes until examined. After all samples are collected, the MMP-8 concentration level will be measured.
MMP-9 concentration level in cyst fluid
Time frame: through study completion, an average of 6 months
Cyst fluids aspirated during the puncture will be centrifuged using a centrifuge and stored at -80 degrees Celsius in Eppendorf tubes until examined. After all samples are collected, the MMP-9 concentration level will be measured.
RANKL concentration level in cyst fluid
Time frame: through study completion, an average of 6 months
Cyst fluids aspirated during the puncture will be centrifuged using a centrifuge and stored at -80 degrees Celsius in Eppendorf tubes until examined. After all samples are collected, the RANKL concentration level will be measured.
MIP-1alpha concentration level in cyst fluid
Time frame: through study completion, an average of 6 months
Cyst fluids aspirated during the puncture will be centrifuged using a centrifuge and stored at -80 degrees Celsius in Eppendorf tubes until examined. After all samples are collected, the MIP-1alpha concentration level will be measured.
1 secondary outcome
Correlation between the type of cyst and the measured markers
Time frame: through study completion, an average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
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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.
hande has elci principal investigator
Harran 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 Biomarkers, run by Harran 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 12 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mine alkaya karagoz (905365417606, minekaragoz@harran.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMP-8 concentration level in cyst fluid (time frame: through study completion, an average of 6 months). The study lists 4 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 12 Sep 2025.