Apical PeriodontitisNCT07320898
Effect of I-PRF Application on ALP and MMP-9 Levels in Teeth With Apical Periodontitis
An observational study of Apical Periodontitis and i-PRF, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis, i-PRF, Biomarkers
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 10 Oct 2025
- 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırıkkale University, Faculty of Dentistry
Kirikkale, Kırıkkale, 71100
About this study
Official title: The Effect of Injectable Platelet-Rich Fibrin on Alkaline Phosphatase and Matrix Metalloproteinase-9 Levels in Periapical Exudate and Gingival Crevicular Fluid of Teeth With Apical Periodontitis
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.
Read the detailed description
The study was conducted with 60 volunteer patients aged 18-64, classified as ASA I, who presented to the Department of Endodontics at the Faculty of Dentistry, Kırıkkale University. They had chronic apical periodontitis in the upper or lower jaw and a periapical lesion diameter of less than 1 cm on either incisor or premolar. Before starting root canal treatment, GCF samples were collected from the included teeth. Plaque on the tooth surface from which GCF samples were to be collected was removed with cotton pellets, and then isolated with a cotton roll. The teeth were dried with compressed air. Paper strips were inserted into the pocket from the mesiobuccal and distobuccal surfaces of the tooth. They were advanced until pressure was felt at the pocket base. GCF was collected by holding the paper strips in the sulcus for 30 seconds. The GCF volume of the paper strips was measured using a Periotron 8000 device, and the researcher recorded the volumes. Paper strips contaminated with blood or saliva were excluded from the study. The paper strips included in the study were placed in Eppendorf tubes and stored at -20°C, then at -80°C, until the ELISA experiments were performed.
Sterile paper points were used to collect periapical exudate samples from teeth after the shaping and irrigation protocols were completed. The root canals were dried to the working length using a #40 paper point. The #20 paper points, adjusted to a length 2 mm longer than the working length, were moved 2 mm from the apical stop and held for 1 minute. The process was repeated three times. A 4-mm cut was made at the ends of the periapical exudate-impregnated paper points with sterile surgical scissors, and the resulting segments were transferred to the Eppendorf tubes. After collecting the periapical sample, calcium hydroxide paste was placed in the canal. The tooth was temporarily sealed with composite resin to prevent contamination between sessions.
The procedures described above were performed identically in both groups. In the i-PRF group, five cc of blood was collected from the patients' antecubital vein into a glass-coated plastic tube without anticoagulant. I-PRF was centrifuged at 700 rpm for 3 minutes. After centrifugation, the i-PRF obtained at the top of the tube was collected using a syringe. The canal length measured during treatment was used to apply i-PRF at the point closest to the tooth apex. To ensure standardization across all patients, 0.5 cc of i-PRF was injected submucosally at the designated site. In the second session, following isolation and disinfection as described in the first session, GCF samples were collected, and after the final irrigation procedure, PAE samples were collected. The root canals were obturated by the lateral condensation method using gutta-percha cones and root canal sealer. Permanent restorations were made with composite resin. The samples were analyzed with ELISA. Data analysis was performed using SPSS 27.0, and a 95% confidence level was achieved. Frequency and percentage (n (%)) are given for categorical (qualitative) variables, while mean, standard deviation, minimum, maximum, and median values are given for numerical (quantitative) variables. The dependent-samples t-test and the Wilcoxon test were used for repeated measurements in the study. The independent-samples t-test and Mann-Whitney U test were used to compare groups. The Spearman correlation test was used for relationships between measurements.
- Conditions
- Apical Periodontitis, i-PRF, Biomarkers, MMP-9, Alkaline Phosphatase
- Keywords
- apical periodontitis, Injectable platelet-rich fibrin, Alkaline phosphatase, Matrix metalloproteinase-9
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 28. Days
Secondary outcomes (1)
Comparison of ALP and MMP-9 Levels Between Sessions and Sample Types
The secondary outcome will evaluate the differences in ALP and MMP-9 levels between the first and second sessions, and between the PAE and GCF samples. ALP values will be evaluated in U/L, and MMP-9 values in ng/dL.
Measured: Baseline and 28. Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 Jan 2025
- Primary completion1 Jun 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Turkyilmaz, Kırıkkale University
- Investigators
- Gamze E NALBANT, Research Assistant, Principal investigator, Kirikkale University Faculty of DentistryAli Türkyılmaz, Associate Professor, Study chair, Kirikkale University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320898
- Sponsor's protocol ID
- 2024/17 - 2024.12.22
- Status last verified
- Mar 2026
- First submitted
- 27 Nov 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Injectable Platelet-Rich Fibrin on Alkaline Phosphatase and Matrix Metalloproteinase-9 Levels in Periapical Exudate and Gingival Crevicular Fluid of Teeth With Apical Periodontitis
- ClinicalTrials.gov ID
- NCT07320898
- Acronym / sponsor ID
- 2024/17 - 2024.12.22
- Conditions
- Apical Periodontitis, i-PRF, Biomarkers, MMP-9, Alkaline Phosphatase
- Keywords
- apical periodontitis, Injectable platelet-rich fibrin, Alkaline phosphatase, Matrix metalloproteinase-9
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 6 Jan 2026 (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 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.
Detailed description
The study was conducted with 60 volunteer patients aged 18-64, classified as ASA I, who presented to the Department of Endodontics at the Faculty of Dentistry, Kırıkkale University. They had chronic apical periodontitis in the upper or lower jaw and a periapical lesion diameter of less than 1 cm on either incisor or premolar. Before starting root canal treatment, GCF samples were collected from the included teeth. Plaque on the tooth surface from which GCF samples were to be collected was removed with cotton pellets, and then isolated with a cotton roll. The teeth were dried with compressed air. Paper strips were inserted into the pocket from the mesiobuccal and distobuccal surfaces of the tooth. They were advanced until pressure was felt at the pocket base. GCF was collected by holding the paper strips in the sulcus for 30 seconds. The GCF volume of the paper strips was measured using a Periotron 8000 device, and the researcher recorded the volumes. Paper strips contaminated with blood or saliva were excluded from the study. The paper strips included in the study were placed in Eppendorf tubes and stored at -20°C, then at -80°C, until the ELISA experiments were performed.
Sterile paper points were used to collect periapical exudate samples from teeth after the shaping and irrigation protocols were completed. The root canals were dried to the working length using a #40 paper point. The #20 paper points, adjusted to a length 2 mm longer than the working length, were moved 2 mm from the apical stop and held for 1 minute. The process was repeated three times. A 4-mm cut was made at the ends of the periapical exudate-impregnated paper points with sterile surgical scissors, and the resulting segments were transferred to the Eppendorf tubes. After collecting the periapical sample, calcium hydroxide paste was placed in the canal. The tooth was temporarily sealed with composite resin to prevent contamination between sessions.
The procedures described above were performed identically in both groups. In the i-PRF group, five cc of blood was collected from the patients' antecubital vein into a glass-coated plastic tube without anticoagulant. I-PRF was centrifuged at 700 rpm for 3 minutes. After centrifugation, the i-PRF obtained at the top of the tube was collected using a syringe. The canal length measured during treatment was used to apply i-PRF at the point closest to the tooth apex. To ensure standardization across all patients, 0.5 cc of i-PRF was injected submucosally at the designated site. In the second session, following isolation and disinfection as described in the first session, GCF samples were collected, and after the final irrigation procedure, PAE samples were collected. The root canals were obturated by the lateral condensation method using gutta-percha cones and root canal sealer. Permanent restorations were made with composite resin. The samples were analyzed with ELISA. Data analysis was performed using SPSS 27.0, and a 95% confidence level was achieved. Frequency and percentage (n (%)) are given for categorical (qualitative) variables, while mean, standard deviation, minimum, maximum, and median values are given for numerical (quantitative) variables. The dependent-samples t-test and the Wilcoxon test were used for repeated measurements in the study. The independent-samples t-test and Mann-Whitney U test were used to compare groups. The Spearman correlation test was used for relationships between measurements.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ALP and MMP-9 Levels in Periapical Exudate (PAE) and Gingival Crevicular Fluid (GCF)
Time frame: Baseline and 28. Days
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.
1 secondary outcome
Comparison of ALP and MMP-9 Levels Between Sessions and Sample Types
Time frame: Baseline and 28. Days
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 31 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Gamze E NALBANT, Research Assistant principal investigator
Kirikkale University Faculty of Dentistry
Ali Türkyılmaz, Associate Professor study chair
Kirikkale University Faculty of Dentistry
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 Apical Periodontitis and i-PRF, run by Kırıkkale 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 5 inclusion and 7 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 31 Mar 2026. 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?
ALP and MMP-9 Levels in Periapical Exudate (PAE) and Gingival Crevicular Fluid (GCF) (time frame: Baseline and 28. Days). 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 31 Mar 2026.