Chronic Apical PeriodontitisREGEN-iPRFNCT07913399
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
A study testing Conventional Root Canal Treatment, Regenerative Endodontic Treatment with i-PRF and Injectable Platelet-Rich Fibrin (i-PRF) in people with Chronic Apical Periodontitis and Pulp Necrosis, run by Medipol University.
Trial summary
This randomized clinical trial aims to compare regenerative endodontic treatment using injectable platelet-rich fibrin (i-PRF) with conventional root canal treatment in mature necrotic anterior teeth with chronic apical periodontitis. Read more about this study
- Who is it for?
- Ages 10 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Apical Periodontitis, Pulp Necrosis
- What is being tested?
- Conventional Root Canal Treatment, Regenerative Endodontic Treatment with i-PRF and Injectable Platelet-Rich Fibrin (i-PRF)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2026to 1 Sep 2027
- Phase
- Interventional
- 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 10 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age between 10 and 45 years
- Mature permanent anterior teeth with a single root and a single canal
- Clinical and radiographic diagnosis of necrotic pulp with chronic apical periodontitis
- Negative response to cold test and Electric Pulp Test (EPT)
- American Society of Anesthesiologists (ASA) physical status I or II
- Ability to provide written informed consent (or assent for minors with parental/guardian consent) and comply with study visit schedules
- For healthy control group: Volunteers with healthy periapical and periodontal status (no apical periodontitis or periodontal disease)
Who cannot join
- Teeth with non-restorable coronal destruction or requiring a post
- Previously root canal-treated teeth
- Periodontal disease with probing depth greater than 4 mm
- Tooth mobility greater than Grade I
- Presence of root fracture or root resorption
- Known allergy to any study medications or materials
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- Patients unable to cooperate or complete scheduled follow-up visits
- Immunosuppressive diseases
- Use of medications affecting healing or blood coagulation (e.g., Nonsteroidal Anti-inflammatory Drugs [NSAIDs], acetylsalicylic acid, antiplatelet drugs)
- Development of crown fracture, root fracture, or severe internal/external root resorption between treatment sessions
About this study
Official title: Evaluation of Clinical Healing and Inflammatory Biomarkers Following Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin Versus Conventional Root Canal Treatment in Mature Necrotic Anterior Teeth With Chronic Apical Periodontitis: A Randomized Clinical Trial
This randomized clinical trial aims to compare regenerative endodontic treatment using injectable platelet-rich fibrin (i-PRF) with conventional root canal treatment in mature necrotic anterior teeth with chronic apical periodontitis. Clinical and radiographic healing, inflammatory biomarkers in gingival crevicular fluid (IL-1β, IL-6, TNF-α), postoperative pain, analgesic intake, and pulp vitality recovery will be evaluated over a 6-month follow-up. A healthy control group will be included for comparison of inflammatory biomarker levels.
Read the detailed description
This single-center, randomized, controlled clinical trial will include 120 participants divided into three groups: a healthy control group (n=40), a conventional root canal treatment group (n=40), and a regenerative endodontic treatment with injectable platelet-rich fibrin (i-PRF) group (n=40).
Baseline clinical and radiographic examinations will include periapical radiographs, pulp vitality tests (cold test and electric pulp test), periodontal assessment, lesion size, Periapical Index (PAI), pain assessment using a visual analogue scale (VAS), and collection of gingival crevicular fluid (GCF) samples for inflammatory biomarker analysis (IL-1β, IL-6, and TNF-α).
All teeth in the treatment groups will receive standardized chemomechanical preparation and calcium hydroxide intracanal medication during the first visit. After three weeks, participants will be randomly assigned to receive either conventional root canal treatment with mineral trioxide aggregate (MTA) obturation or regenerative endodontic treatment using induced bleeding, injectable platelet-rich fibrin (i-PRF), CollaCote membrane, and MTA. Blood samples collected from both treatment groups will be analyzed for growth factors (TGF-β, IGF, and FGF) using ELISA.
Postoperative pain will be recorded using VAS at 12 hours, 24 hours, 3 days, and 7 days. Analgesic intake and postoperative swelling will also be documented.
At the 6-month follow-up, clinical examination, periapical radiography, gingival crevicular fluid sampling, and pulp vitality testing will be repeated. The primary outcome will be clinical and radiographic healing based on modified Periapical Index (PAI) criteria. Secondary outcomes include changes in inflammatory biomarker levels, postoperative pain intensity, analgesic consumption, postoperative swelling, and recovery of pulp vitality in the regenerative treatment group.
- Conditions
- Chronic Apical Periodontitis, Pulp Necrosis
- Being tested
- Conventional Root Canal Treatment, Regenerative Endodontic Treatment with i-PRF, Injectable Platelet-Rich Fibrin (i-PRF)
- Keywords
- Regenerative Endodontics, Injectable Platelet-Rich Fibrin (i-PRF), Root Canal Treatment, Chronic Apical Periodontitis, Mature Necrotic Teeth, Periapical Healing, Inflammatory Biomarkers, Gingival Crevicular Fluid, Pulp Vitality, Randomized Clinical Trial
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Root Canal TreatmentProcedure or surgery
Conventional root canal treatment performed according to the study protocol using chemomechanical preparation, calcium hydroxide intracanal medication, and mineral trioxide aggregate (MTA) obturation.
Regenerative Endodontic Treatment with i-PRFProcedure or surgery
Regenerative endodontic treatment performed using induced bleeding, injectable platelet-rich fibrin (i-PRF), CollaCote membrane, and mineral trioxide aggregate (MTA) according to the study protocol.
Injectable Platelet-Rich Fibrin (i-PRF)Biological
Autologous injectable platelet-rich fibrin prepared from the participant's peripheral blood and used as a scaffold during regenerative endodontic treatment.
| Study group | Role | What they receive |
|---|---|---|
| Healthy control | No intervention | Healthy participants without apical periodontitis or periodontal disease. No intervention will be performed. Gingival crevicular fluid samples will be collected at baseline and at the 6-month follow-up for inflammatory biomarker analysis. |
| Conventional Root Canal Treatment | Active comparator | Participants with chronic apical periodontitis treated with conventional root canal treatment according to the study protocol. Receives: Procedure: Conventional Root Canal Treatment |
| Regenerative Endodontic Treatment (i-PRF) | Experimental | Participants with chronic apical periodontitis treated with regenerative endodontic treatment using injectable platelet-rich fibrin (i-PRF) according to the study protocol. Receives: Procedure: Regenerative Endodontic Treatment with i-PRF; Biological: Injectable Platelet-Rich Fibrin (i-PRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periapical Radiographic Healing Evaluated by Modified Periapical Index (PAI) Score
Radiographic evaluation of periapical tissue status and bone healing on standardized parallel periapical radiographs using the unabbreviated Modified Periapical Index (PAI) scale. The PAI is a 5-point scale ranging from 1 to 5: minimum value = 1 (normal periapical structure / complete healing / best outcome), maximum value = 5 (severe periodontitis with exacerbating features / worse outcome). Higher scores represent worse periapical status (worse outcome).
Measured: Baseline and 6 months post-treatment
Clinical Treatment Success Rate
Percentage of participants achieving complete clinical treatment success, defined as the absence of all clinical signs and symptoms (spontaneous pain, tenderness to percussion, tenderness to palpation, swelling, and sinus tract) along with normal tooth function.
Measured: 6 months post-treatment
Secondary outcomes (4)
Postoperative Pain Intensity Evaluated by Visual Analog Scale (VAS)
Self-reported postoperative pain intensity measured using the unabbreviated Visual Analog Scale (VAS). The VAS is a 10-point scale ranging from 0 to 10: minimum value = 0 (no pain / best outcome), maximum value = 10 (worst imaginable pain / worse outcome). Higher scores represent higher pain intensity (worse outcome).
Measured: 12 hours, 24 hours, Day 3, and Day 7 after the second treatment session
Analgesic Consumption
Number of ibuprofen tablets taken after treatment will be recorded based on patient diaries.
Measured: From the second treatment session to Day 7
Pulp Vitality Response
Recovery of pulp vitality will be evaluated using cold testing and electric pulp testing (EPT). EPT measurements will be performed twice and the numerical values will be recorded. Responses will be categorized as normal, sensitive, dull, or no response.
Measured: 6 months after treatment
Gingival Crevicular Fluid Inflammatory Biomarkers
Levels of IL-1β, IL-6, and TNF-α in gingival crevicular fluid will be measured and compared between baseline and the 6-month follow-up.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start15 Nov 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Apical PeriodontitisStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants with chronic apical periodontitis will be randomized to receive either conventional root canal treatment or regenerative endodontic treatment using i-PRF. A healthy control group will be included for comparison of inflammatory biomarkers without receiving any intervention.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Degirmencioglu, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913399
- Sponsor's protocol ID
- MedipolU-449
- Acronym
- REGEN-iPRF
- Status last verified
- Nov 2026
- First submitted
- 25 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Healing and Inflammatory Biomarkers Following Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin Versus Conventional Root Canal Treatment in Mature Necrotic Anterior Teeth With Chronic Apical Periodontitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07913399
- Acronym / sponsor ID
- REGEN-iPRF / MedipolU-449
- Conditions
- Chronic Apical Periodontitis, Pulp Necrosis
- Keywords
- Regenerative Endodontics, Injectable Platelet-Rich Fibrin (i-PRF), Root Canal Treatment, Chronic Apical Periodontitis, Mature Necrotic Teeth, Periapical Healing, Inflammatory Biomarkers, Gingival Crevicular Fluid
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 3 Nov 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.
This randomized clinical trial aims to compare regenerative endodontic treatment using injectable platelet-rich fibrin (i-PRF) with conventional root canal treatment in mature necrotic anterior teeth with chronic apical periodontitis. Clinical and radiographic healing, inflammatory biomarkers in gingival crevicular fluid (IL-1β, IL-6, TNF-α), postoperative pain, analgesic intake, and pulp vitality recovery will be evaluated over a 6-month follow-up. A healthy control group will be included for comparison of inflammatory biomarker levels.
Detailed description
This single-center, randomized, controlled clinical trial will include 120 participants divided into three groups: a healthy control group (n=40), a conventional root canal treatment group (n=40), and a regenerative endodontic treatment with injectable platelet-rich fibrin (i-PRF) group (n=40).
Baseline clinical and radiographic examinations will include periapical radiographs, pulp vitality tests (cold test and electric pulp test), periodontal assessment, lesion size, Periapical Index (PAI), pain assessment using a visual analogue scale (VAS), and collection of gingival crevicular fluid (GCF) samples for inflammatory biomarker analysis (IL-1β, IL-6, and TNF-α).
All teeth in the treatment groups will receive standardized chemomechanical preparation and calcium hydroxide intracanal medication during the first visit. After three weeks, participants will be randomly assigned to receive either conventional root canal treatment with mineral trioxide aggregate (MTA) obturation or regenerative endodontic treatment using induced bleeding, injectable platelet-rich fibrin (i-PRF), CollaCote membrane, and MTA. Blood samples collected from both treatment groups will be analyzed for growth factors (TGF-β, IGF, and FGF) using ELISA.
Postoperative pain will be recorded using VAS at 12 hours, 24 hours, 3 days, and 7 days. Analgesic intake and postoperative swelling will also be documented.
At the 6-month follow-up, clinical examination, periapical radiography, gingival crevicular fluid sampling, and pulp vitality testing will be repeated. The primary outcome will be clinical and radiographic healing based on modified Periapical Index (PAI) criteria. Secondary outcomes include changes in inflammatory biomarker levels, postoperative pain intensity, analgesic consumption, postoperative swelling, and recovery of pulp vitality in the regenerative treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants with chronic apical periodontitis will be randomized to receive either conventional root canal treatment or regenerative endodontic treatment using i-PRF. A healthy control group will be included for comparison of inflammatory biomarkers without receiving any intervention.
| Arm | Type | Receives |
|---|---|---|
| Healthy control | No intervention | –Healthy participants without apical periodontitis or periodontal disease. No intervention will be performed. Gingival crevicular fluid samples will be collected at baseline and at the 6-month follow-up for inflammatory biomarker analysis. |
| Conventional Root Canal Treatment | Active comparator | Procedure: Conventional Root Canal TreatmentParticipants with chronic apical periodontitis treated with conventional root canal treatment according to the study protocol. |
| Regenerative Endodontic Treatment (i-PRF) | Experimental | Procedure: Regenerative Endodontic Treatment with i-PRF, Biological: Injectable Platelet-Rich Fibrin (i-PRF)Participants with chronic apical periodontitis treated with regenerative endodontic treatment using injectable platelet-rich fibrin (i-PRF) according to the study protocol. |
Who may qualify
- Ages
- 10 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age between 10 and 45 years
- Mature permanent anterior teeth with a single root and a single canal
- Clinical and radiographic diagnosis of necrotic pulp with chronic apical periodontitis
- Negative response to cold test and Electric Pulp Test (EPT)
- American Society of Anesthesiologists (ASA) physical status I or II
Key exclusion criteria (10 listed)
- Teeth with non-restorable coronal destruction or requiring a post
- Previously root canal-treated teeth
- Periodontal disease with probing depth greater than 4 mm
- Tooth mobility greater than Grade I
- Presence of root fracture or root resorption
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 |
|---|---|---|
| Conventional Root Canal TreatmentConventional root canal treatment performed according to the study protocol using chemomechanical preparation, calcium hydroxide intracanal medication, and mineral trioxide aggregate (MTA) obturation. | Procedure or surgery | Conventional Root Canal Treatment |
| Regenerative Endodontic Treatment with i-PRFRegenerative endodontic treatment performed using induced bleeding, injectable platelet-rich fibrin (i-PRF), CollaCote membrane, and mineral trioxide aggregate (MTA) according to the study protocol. | Procedure or surgery | Regenerative Endodontic Treatment (i-PRF) |
| Injectable Platelet-Rich Fibrin (i-PRF)Autologous injectable platelet-rich fibrin prepared from the participant's peripheral blood and used as a scaffold during regenerative endodontic treatment. | Biological | Regenerative Endodontic Treatment (i-PRF) |
Primary outcome
Periapical Radiographic Healing Evaluated by Modified Periapical Index (PAI) Score
Time frame: Baseline and 6 months post-treatment
Radiographic evaluation of periapical tissue status and bone healing on standardized parallel periapical radiographs using the unabbreviated Modified Periapical Index (PAI) scale. The PAI is a 5-point scale ranging from 1 to 5: minimum value = 1 (normal periapical structure / complete healing / best outcome), maximum value = 5 (severe periodontitis with exacerbating features / worse outcome). Higher scores represent worse periapical status (worse outcome).
Clinical Treatment Success Rate
Time frame: 6 months post-treatment
Percentage of participants achieving complete clinical treatment success, defined as the absence of all clinical signs and symptoms (spontaneous pain, tenderness to percussion, tenderness to palpation, swelling, and sinus tract) along with normal tooth function.
4 secondary outcomes
Postoperative Pain Intensity Evaluated by Visual Analog Scale (VAS)
Time frame: 12 hours, 24 hours, Day 3, and Day 7 after the second treatment session
Analgesic Consumption
Time frame: From the second treatment session to Day 7
Pulp Vitality Response
Time frame: 6 months after treatment
Gingival Crevicular Fluid Inflammatory Biomarkers
Time frame: Baseline and 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 3 Nov 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Root Canal Treatment, Regenerative Endodontic Treatment with i-PRF and Injectable Platelet-Rich Fibrin (i-PRF) in people with Chronic Apical Periodontitis and Pulp Necrosis, run by Medipol University.
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 7 inclusion and 10 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: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Periapical Radiographic Healing Evaluated by Modified Periapical Index (PAI) Score (time frame: Baseline and 6 months post-treatment). The study lists 2 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 3 Nov 2026.