Evaluation of Revitalization Success Using i-PRF in Non-Surgical Root Canal Retreatment
1 other identifier
interventional
140
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2025
CompletedFirst Submitted
Initial submission to the registry
February 26, 2026
CompletedFirst Posted
Study publicly available on registry
March 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
March 4, 2026
February 1, 2026
1.1 years
February 26, 2026
February 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline and up to 24 months
Secondary Outcomes (4)
Postoperative Pain Intensity
Baseline and up to 24 months
Percussion and Palpation Sensitivity
Baseline and up to 24 months
Pulp Vitality Response
Baseline and up to 24 months
Proportion of Teeth With Successful Healing (PAI ≤ 2)
Baseline and up to 24 months
Study Arms (2)
Conventional Non-Surgical Root Canal Retreatment
ACTIVE COMPARATORParticipants will receive conventional non-surgical root canal retreatment.
Regenerative Endodontic Treatment With Injectable Platelet-Rich Fibrin
EXPERIMENTALParticipants will receive regenerative endodontic treatment using injectable platelet-rich fibrin as a biological scaffold.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Marmara University
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Idil OZDEN, PhD
Marmara University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
February 26, 2026
First Posted
March 4, 2026
Study Start
May 1, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
March 4, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share