Comparison of Aquaporin -4, -5, -9 and IL-8 Levels in GCF, Dentin Fluid and Pulp Samples

NCT06938191 | Not Yet Recruiting

• 1 other identifier: 2025/05-2025.03.02
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aimed to compare the changes in AQP -4, -5, -9, and IL-8 levels in pulp tissue, GCF, and dentin fluid samples routinely obtained during the treatment of healthy and symptomatic teeth diagnosed with irreversible pulpitis and investigate whether there is a correlation between them. A total of 70 patients aged 18-64 years with healthy (Group 1) and symptomatic irreversible pulpitis (Group 2) diagnosed at Kırıkkale University, Faculty of Dentistry, Department of Endodontics who will undergo routine root canal treatment will be included in the study, with a minimum of 35 participants for each group. Before starting treatment, DOS samples will be taken from healthy, symptomatic, irreversible pulpitis-diagnosed teeth and teeth contralateral to these teeth. A dentin fluid sample will be taken by holding the membrane on the dentin surface, and the pulp tissue will be removed and transferred to Eppendorf tubes. The treatment process will be completed by applying routine root canal procedures to the teeth. The samples' Aquaporin -4, -5, -9, and IL-8 levels will be analyzed by specific enzyme-linked immunosorbent assay (ELISA).

Conditions

Pulpitis; Pulpitis - Irreversible; Pulp Inflammation; Healthy Pulp; Biomarkers

Keywords

healthy pulp; pulpitis; irreversible pulpitis; aquaporin-4; IL-8; aquaporin-5; aquaporin-9

Outcome Measures

Primary Outcomes (1)

• Aquaporin-4, Aquaporin-5 and Aquaporin-9 expression levels in pulp tissue in dentin fluid and GCF samples

  Levels of IL-8, AQP-4, AQP-5 and AQP-9 will be measured in dentin fluid, GCF and pulp tissue samples obtained during routine root canal treatment. The analysis will be performed using ELISA. The aim is to compare the expression levels between healthy individuals and patients with irreversible pulpitis.

  Immediately after the procedure

Secondary Outcomes (1)

• Correlation analysis between Aquaporin (AQP-4, AQP-5, AQP-9) and IL-8 levels in pulp tissue, dentin fluid, and GCF samples

  Immediately after the procedure

Study Arms (2)

healthy pulp group

Minimum 35 participants Procedure: Collection of GCF samples using periopaper. Collection of dentinal fluid using cellulose membrane. Collection of pulp tissue samples using a tirnerf.

irreversible pulp group

Minimum 35 participants Procedure: Collection of GCF samples using periopaper. Collection of dentinal fluid using cellulose membrane. Collection of pulp tissue samples using a tirnerf.

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study will include patients aged 18-64 years who present to the Department of Endodontics, Faculty of Dentistry, Kırıkkale University, with an indication for root canal therapy and are diagnosed with either a healthy pulp status (Group 1) or symptomatic irreversible pulpitis (Group 2).

You may qualify if:

• Patients aged 18 to 64 years.
• Patients without any known systemic disease.
• Patients requiring root canal treatment for prosthetic purposes (Healthy pulp group).
• Patients with third molars (wisdom teeth) indicated for extraction due to orthodontic or other clinical reasons (Healthy pulp group).
• Patients diagnosed with symptomatic irreversible pulpitis based on the criteria established by the American Association of Endodontists (AAE) (Symptomatic irreversible pulpitis group).
• Patients scheduled for routine root canal treatment at the Department of Endodontics, Faculty of Dentistry, Kırıkkale University.
• Patients who have provided written informed consent to participate in the study.

You may not qualify if:

• Patients with any known systemic disease.
• Pregnant women or those suspected of being pregnant.
• Patients who have used antibiotics, anti-inflammatory drugs, or antidepressants within the past 4 weeks.
• Patients with significant dental plaque or calculus, gingival redness or bleeding, severe gingivitis, generalized periodontitis, or periodontal pockets deeper than 4 mm.
• Patients with teeth showing internal or external root resorption.
• Patients for whom complete rubber dam isolation cannot be achieved.
• Patients with teeth exhibiting signs of necrosis, apical lesions, swelling, or presence of a sinus tract.
• Patients with immature teeth presenting open apices.
• Patients with third molars (wisdom teeth) that are not fully erupted or have been previously diagnosed with pericoronitis.

Sponsors & Collaborators

• Kırıkkale University: lead

MeSH Terms

Conditions

Pulpitis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• TANSU M BEŞPARMAK, PhD student

  Kirikkale University, Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

• ALİ ERDEMİR, PROF

  Kirikkale University, Faculty of Dentistry

  STUDY CHAIR

Central Study Contacts

ALİ ERDEMİR, PROF.

CONTACT

+905325650065; erdemirali@hotmail.com

TANSU M BEŞPARMAK

CONTACT

+905398973940; tansumervebesparmak@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor doctor

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 22, 2025
• Study Start: December 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): September 12, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-08