Effect of I-PRF Application on ALP and MMP-9 Levels in Teeth With Apical Periodontitis

NCT07320898 | Completed

• 1 other identifier: 2024/17 - 2024.12.22
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate the effect of injectable platelet rich fibrin (i-PRF) injection, in addition to routine root canal treatment, on alkaline phosphatase (ALP) and matrix metalloproteinase-9 (MMP-9) levels in teeth with chronic apical periodontitis. A total of 60 patients were included and randomly divided into two groups: the control group and the experimental group (i-PRF). Gingival crevicular fluid (GCF) samples and periapical exudate (PAE) samples were collected from the teeth at the first appointment, after completion of chemomechanical preparation. In both groups, calcium hydroxide was placed in the root canals, and the teeth were temporarily sealed with composite resin. While no additional procedure was performed in the control group, patients in the experimental group received submucosal i-PRF injection. The second samples were obtained after 4 weeks, and in the same session, the root canal treatment was completed, followed by permanent restoration. ALP and MMP-9 levels in the collected samples were analyzed using the ELISA test.

Conditions

i-PRF; Apical Periodontitis; Biomarkers; MMP-9; Alkaline Phosphatase

Keywords

apical periodontitis; Injectable platelet-rich fibrin; Alkaline phosphatase; Matrix metalloproteinase-9

Outcome Measures

Primary Outcomes (1)

• ALP and MMP-9 Levels in Periapical Exudate (PAE) and Gingival Crevicular Fluid (GCF)

  In teeth with apical periodontitis, periapical exudate (PAE) and gingival crevicular fluid (GCF) collected during the first and second sessions of root canal treatment will be analyzed to measure alkaline phosphatase (ALP) and matrix metalloproteinase-9 (MMP-9) levels. ALP levels will be expressed in U/L, while MMP-9 levels will be expressed in ng/dL, and each enzyme will be measured and reported separately. Enzyme levels will be compared between the group receiving injectable platelet-rich fibrin (i-PRF) and the group not receiving i-PRF.

  Baseline and 28. Days

Secondary Outcomes (1)

• Comparison of ALP and MMP-9 Levels Between Sessions and Sample Types

  Baseline and 28. Days

Study Arms (2)

Control Group

30 participants. Procedure: Root canal treatment without i-PRF application. Collection of GCF and PAE samples.

I-PRF Group

30 participants. Procedure: i-PRF application and root canal treatment. Collection of GCF and PAE samples.

Eligibility Criteria

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

Study Population

Patients between the ages of 18-64 years old and diagnosed with apical periodontitis who applied to Kırıkkale University, Faculty of Dentistry, Department of Endodontics with the indication of root canal treatment will be included in the study.

You may qualify if:

• Sixty patients who applied to Kırıkkale University Faculty of Dentistry and were diagnosed with chronic apical periodontitis and were included in the PAI 3-4 groups according to the Periapical Index Scoring System (PAI) among the patients who were prescribed root canal treatment were included in the study.
• Patients aged 18-64
• Upper or lower incisors and premolars with primary apical periodontitis
• Patients with ASA I
• Patients who have provided written informed consent to participate in the study.

You may not qualify if:

• Patients with ASA II or higher,
• Patients who have used antibiotics and anti-inflammatory medications within the last month,
• Patients with a periodontal pocket greater than 3 mm in the affected tooth,
• Teeth with internal or external root resorption, or teeth with swelling and pain on palpation,
• Pregnant women or those suspected of pregnancy,
• Patients with generalized periodontitis,
• Patients with immunosuppressive systemic diseases such as diabetes and hepatitis will not be included in the study.

Sponsors & Collaborators

• Kırıkkale University: lead

Study Sites (1)

Kırıkkale University, Faculty of Dentistry

Kırıkkale, Kırıkkale, 71100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Officials

• Gamze E NALBANT, Research Assistant

  Kirikkale University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

• Ali Türkyılmaz, Associate Professor

  Kirikkale University Faculty of Dentistry

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: January 6, 2026
• Study Start: January 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: October 10, 2025
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

TU (1)