Apical PeriodontitisNCT07448571
Evaluation of Revitalization Success Using i-PRF in Non-Surgical Root Canal Retreatment
A study testing Non-Surgical Root Canal Retreatment and Regenerative Endodontic Treatment in people with Apical Periodontitis and Periapical Diseases, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this randomized controlled clinical trial is to determine whether regenerative endodontic treatment can improve healing outcomes in teeth with apical periodontitis following failed root canal treatment. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Apical Periodontitis, Periapical Diseases
- What is being tested?
- Non-Surgical Root Canal Retreatment and Regenerative Endodontic Treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 1 Dec 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged between 18 and 50 years.
- Single-rooted maxillary anterior teeth with closed apices.
- Presence of periapical lesion confirmed radiographically.
- Previously treated root canal tooth requiring non-surgical retreatment.
- Tooth has not previously undergone non-surgical root canal retreatment.
- Tooth is considered restorable.
- Patient is systemically healthy.
- Patient is willing to participate and provides informed consent.
Who cannot join
- Teeth without radiographic evidence of periapical lesion.
- Teeth with developmental anomalies.
- Patients with systemic diseases that may affect healing.
- Pregnant patients.
- Teeth presenting with internal or external root resorption.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Idil OZDEN, PhD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University
Istanbul
Melike Kaplanoglu, DDS, 905319330396, melikekaplanoglu37@gmail.com
Idil Ozden, DDS, PhD, idil.akman94@gmail.com
About this study
Official title: Evaluation of Revitalization Success Using i-PRF in Non-Surgical Root Canal Retreatment: A Clinical Study
The goal of this randomized controlled clinical trial is to determine whether regenerative endodontic treatment can improve healing outcomes in teeth with apical periodontitis following failed root canal treatment. The study includes adult patients who require non-surgical root canal retreatment due to persistent periapical lesions.
The main questions it aims to answer are:
Read more
Does regenerative endodontic treatment improve periapical healing compared with conventional non-surgical root canal retreatment? Does regenerative treatment increase long-term treatment success and tooth survival? Researchers will compare conventional non-surgical root canal retreatment with regenerative endodontic treatment using injectable platelet-rich fibrin (i-PRF) to see if the regenerative approach results in better clinical and radiographic outcomes.
Participants will:
Be randomly assigned to receive either conventional retreatment or regenerative endodontic treatment.
Undergo clinical and radiographic evaluations over a two-year follow-up period. Be assessed for pain, sensitivity, pulp vitality, hard tissue formation, and periapical healing.
Read the detailed description
Apical periodontitis is a common consequence of failed root canal treatment and is primarily associated with persistent intraradicular infection. Although non-surgical root canal retreatment remains the standard treatment approach for failed primary endodontic therapy, reported failure rates range between 23% and 30%. Even after thorough chemomechanical preparation, complete elimination of microorganisms may not always be achieved. In addition, conventional treatment does not restore pulp vitality and may compromise the structural integrity of the remaining tooth tissue.
Regenerative endodontic procedures have emerged as a biologically based alternative aimed at promoting tissue regeneration within the root canal system. By utilizing biological scaffolds and growth factor-rich preparations, regenerative therapy may enhance healing, support revascularization, and potentially restore natural defense mechanisms of the tooth.
This study is designed as a randomized controlled clinical trial comparing conventional non-surgical root canal retreatment with regenerative endodontic treatment. The regenerative protocol incorporates injectable platelet-rich fibrin (i-PRF), an autologous blood-derived biomaterial obtained through low-speed centrifugation. i-PRF contains growth factors and bioactive components that may support angiogenesis, cell migration, and tissue repair.
Following local anesthesia and rubber dam isolation, previously obturated root canal fillings will be removed. Standardized chemomechanical preparation and irrigation protocols will be performed according to the assigned treatment group. In the regenerative group, i-PRF will be applied as a biological scaffold prior to placement of a bioceramic material to achieve coronal sealing. In the conventional retreatment group, canals will be obturated using established root canal filling techniques.
All procedures will be performed under standardized clinical conditions. Radiographic examinations will be obtained using positioning devices to ensure reproducibility and standardization of angulation. Patients will be monitored periodically over a two-year follow-up period to assess healing progression and treatment outcomes.
This study seeks to provide evidence regarding the biological and clinical potential of regenerative endodontic therapy as an alternative to conventional retreatment in teeth with persistent apical periodontitis.
- Conditions
- Apical Periodontitis, Periapical Diseases
- Being tested
- Non-Surgical Root Canal Retreatment, Regenerative Endodontic Treatment
- Keywords
- apical periodontitis, root canal retreatment, regenerative endodontic treatment, Injectable Platelet-Rich Fibrin, Non-Surgical Endodontic Retreatment, Periapical Healing, Randomized Controlled Trial
- Medical subject headings
- Periapical Periodontitis, Periapical Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Surgical Root Canal RetreatmentProcedure or surgery
Conventional non-surgical root canal retreatment will be performed under local anesthesia and rubber dam isolation. Previous root canal filling materials will be removed, followed by standardized chemomechanical preparation and irrigation. The canals will be obturated using resin-based sealer and gutta-percha with lateral condensation technique, and the tooth will be restored with a permanent coronal restoration.
Regenerative Endodontic TreatmentProcedure or surgery
Regenerative endodontic treatment will be performed under local anesthesia and rubber dam isolation. After removal of previous root canal filling materials and standardized canal preparation, injectable platelet-rich fibrin obtained from the patient's autologous blood will be applied into the canal space as a biological scaffold. Mineral trioxide aggregate will be placed coronally, followed by permanent composite restoration.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Non-Surgical Root Canal Retreatment | Active comparator | Participants will receive conventional non-surgical root canal retreatment. Receives: Procedure: Non-Surgical Root Canal Retreatment |
| Regenerative Endodontic Treatment With Injectable Platelet-Rich Fibrin | Experimental | Participants will receive regenerative endodontic treatment using injectable platelet-rich fibrin as a biological scaffold. Receives: Procedure: Regenerative Endodontic Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Periapical Index (PAI) Score
Periapical healing will be assessed using standardized periapical radiographs and scored according to the Periapical Index (PAI) system. Changes in lesion size and PAI scores from baseline to follow-up visits over a 24-month period will be evaluated.
Measured: Baseline and up to 24 months
Secondary outcomes (4)
Postoperative Pain Intensity
Postoperative pain intensity will be assessed at follow-up visits using clinical evaluation and patient-reported outcomes when applicable.
Measured: Baseline and up to 24 months
Percussion and Palpation Sensitivity
Clinical evaluation of percussion and palpation sensitivity will be performed at scheduled follow-up visits to assess signs of persistent inflammation or tenderness.
Measured: Baseline and up to 24 months
Pulp Vitality Response
Pulp vitality will be assessed using standardized vitality testing methods during follow-up visits to determine restoration of tooth vitality.
Measured: Baseline and up to 24 months
Proportion of Teeth With Successful Healing (PAI ≤ 2)
Successful healing will be defined as a Periapical Index (PAI) score of 2 or lower at follow-up evaluations. The proportion of teeth achieving successful healing within 24 months will be compared between treatment groups.
Measured: Baseline and up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start1 May 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
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.
- More trials run by Marmara 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 will be randomly assigned in a 1:1 ratio to one of two parallel treatment groups. One group will receive conventional non-surgical root canal retreatment, and the other group will receive regenerative endodontic treatment using injectable platelet-rich fibrin. Each participant will receive only one assigned intervention and will be followed prospectively for outcome assessment.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melike Beyza Kaplanoğlu, Marmara University
- Investigators
- Idil OZDEN, PhD, Study chair, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448571
- Sponsor's protocol ID
- 2025-KAEK-43
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Revitalization Success Using i-PRF in Non-Surgical Root Canal Retreatment: A Clinical Study
- ClinicalTrials.gov ID
- NCT07448571
- Acronym / sponsor ID
- 2025-KAEK-43
- Conditions
- Apical Periodontitis, Periapical Diseases
- Keywords
- apical periodontitis, root canal retreatment, regenerative endodontic treatment, Injectable Platelet-Rich Fibrin, Non-Surgical Endodontic Retreatment, Periapical Healing, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 4 Mar 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 goal of this randomized controlled clinical trial is to determine whether regenerative endodontic treatment can improve healing outcomes in teeth with apical periodontitis following failed root canal treatment. The study includes adult patients who require non-surgical root canal retreatment due to persistent periapical lesions.
The main questions it aims to answer are:
Does regenerative endodontic treatment improve periapical healing compared with conventional non-surgical root canal retreatment? Does regenerative treatment increase long-term treatment success and tooth survival? Researchers will compare conventional non-surgical root canal retreatment with regenerative endodontic treatment using injectable platelet-rich fibrin (i-PRF) to see if the regenerative approach results in better clinical and radiographic outcomes.
Participants will:
Be randomly assigned to receive either conventional retreatment or regenerative endodontic treatment.
Undergo clinical and radiographic evaluations over a two-year follow-up period. Be assessed for pain, sensitivity, pulp vitality, hard tissue formation, and periapical healing.
Detailed description
Apical periodontitis is a common consequence of failed root canal treatment and is primarily associated with persistent intraradicular infection. Although non-surgical root canal retreatment remains the standard treatment approach for failed primary endodontic therapy, reported failure rates range between 23% and 30%. Even after thorough chemomechanical preparation, complete elimination of microorganisms may not always be achieved. In addition, conventional treatment does not restore pulp vitality and may compromise the structural integrity of the remaining tooth tissue.
Regenerative endodontic procedures have emerged as a biologically based alternative aimed at promoting tissue regeneration within the root canal system. By utilizing biological scaffolds and growth factor-rich preparations, regenerative therapy may enhance healing, support revascularization, and potentially restore natural defense mechanisms of the tooth.
This study is designed as a randomized controlled clinical trial comparing conventional non-surgical root canal retreatment with regenerative endodontic treatment. The regenerative protocol incorporates injectable platelet-rich fibrin (i-PRF), an autologous blood-derived biomaterial obtained through low-speed centrifugation. i-PRF contains growth factors and bioactive components that may support angiogenesis, cell migration, and tissue repair.
Following local anesthesia and rubber dam isolation, previously obturated root canal fillings will be removed. Standardized chemomechanical preparation and irrigation protocols will be performed according to the assigned treatment group. In the regenerative group, i-PRF will be applied as a biological scaffold prior to placement of a bioceramic material to achieve coronal sealing. In the conventional retreatment group, canals will be obturated using established root canal filling techniques.
All procedures will be performed under standardized clinical conditions. Radiographic examinations will be obtained using positioning devices to ensure reproducibility and standardization of angulation. Patients will be monitored periodically over a two-year follow-up period to assess healing progression and treatment outcomes.
This study seeks to provide evidence regarding the biological and clinical potential of regenerative endodontic therapy as an alternative to conventional retreatment in teeth with persistent apical periodontitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel treatment groups. One group will receive conventional non-surgical root canal retreatment, and the other group will receive regenerative endodontic treatment using injectable platelet-rich fibrin. Each participant will receive only one assigned intervention and will be followed prospectively for outcome assessment.
| Arm | Type | Receives |
|---|---|---|
| Conventional Non-Surgical Root Canal Retreatment | Active comparator | Procedure: Non-Surgical Root Canal RetreatmentParticipants will receive conventional non-surgical root canal retreatment. |
| Regenerative Endodontic Treatment With Injectable Platelet-Rich Fibrin | Experimental | Procedure: Regenerative Endodontic TreatmentParticipants will receive regenerative endodontic treatment using injectable platelet-rich fibrin as a biological scaffold. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients aged between 18 and 50 years.
- Single-rooted maxillary anterior teeth with closed apices.
- Presence of periapical lesion confirmed radiographically.
- Previously treated root canal tooth requiring non-surgical retreatment.
- Tooth has not previously undergone non-surgical root canal retreatment.
Key exclusion criteria (5 listed)
- Teeth without radiographic evidence of periapical lesion.
- Teeth with developmental anomalies.
- Patients with systemic diseases that may affect healing.
- Pregnant patients.
- Teeth presenting with internal or external 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 |
|---|---|---|
| Non-Surgical Root Canal RetreatmentConventional non-surgical root canal retreatment will be performed under local anesthesia and rubber dam isolation. Previous root canal filling materials will be removed, followed by standardized chemomechanical preparation and irrigation. The canals will be obturated using resin-based sealer and gutta-percha with lateral condensation technique, and the tooth will be restored with a permanent coronal restoration. | Procedure or surgery | Conventional Non-Surgical Root Canal Retreatment |
| Regenerative Endodontic TreatmentRegenerative endodontic treatment will be performed under local anesthesia and rubber dam isolation. After removal of previous root canal filling materials and standardized canal preparation, injectable platelet-rich fibrin obtained from the patient's autologous blood will be applied into the canal space as a biological scaffold. Mineral trioxide aggregate will be placed coronally, followed by permanent composite restoration. | Procedure or surgery | Regenerative Endodontic Treatment With Injectable Platelet-Rich Fibrin |
Primary outcome
Change in Periapical Index (PAI) Score
Time frame: Baseline and up to 24 months
Periapical healing will be assessed using standardized periapical radiographs and scored according to the Periapical Index (PAI) system. Changes in lesion size and PAI scores from baseline to follow-up visits over a 24-month period will be evaluated.
4 secondary outcomes
Postoperative Pain Intensity
Time frame: Baseline and up to 24 months
Percussion and Palpation Sensitivity
Time frame: Baseline and up to 24 months
Pulp Vitality Response
Time frame: Baseline and up to 24 months
Proportion of Teeth With Successful Healing (PAI ≤ 2)
Time frame: Baseline and up to 24 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 4 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Idil OZDEN, PhD contact
Idil OZDEN, PhD study chair
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Surgical Root Canal Retreatment and Regenerative Endodontic Treatment in people with Apical Periodontitis and Periapical Diseases, run by Marmara 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 8 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 4 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?
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?
Contact Melike B KAPLANOGLU (905319330396, melikekaplanoglu37@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Periapical Index (PAI) Score (time frame: Baseline and up to 24 months). 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 4 Mar 2026.