NCT07171151

Brief 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? 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

August 25, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

August 25, 2025

Last Update Submit

September 9, 2025

Conditions

Keywords

odontogenic cystsbiomarkersMMP-8MIP-1alfa

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    through study completion, an average of 6 months

Secondary Outcomes (1)

  • Correlation between the type of cyst and the measured markers

    through study completion, an average of 6 months

Study Arms (1)

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.

Other: cyst fluid examination

Interventions

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.

individuals with odontogenic cysts

Eligibility Criteria

Age12 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Individuals diagnosed with cysts
  • Individuals who are not pregnant or breastfeeding
  • Individuals who agree to sign the informed consent form

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harran University, Faculty of Dentistry

Sanliurfa, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Cyst fluid obtained during puncture

MeSH Terms

Conditions

Odontogenic Cysts

Condition Hierarchy (Ancestors)

Jaw CystsBone CystsCystsNeoplasmsJaw DiseasesMusculoskeletal DiseasesStomatognathic Diseases

Study Officials

  • hande has elci

    Harran University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 25, 2025

First Posted

September 12, 2025

Study Start

August 25, 2025

Primary Completion

December 1, 2025

Study Completion

May 1, 2026

Last Updated

September 12, 2025

Record last verified: 2025-09

Locations