Evaluation of Revitalization Success Using i-PRF in Non-Surgical Root Canal Retreatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorMarmara University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Teeth without radiographic evidence of periapical lesion.
Teeth with developmental anomalies.
Patients with systemic diseases that may affect healing.
Pregnant patients.
Trial design
Design model
Parallel
Treatments tested in this trial
Non-Surgical Root Canal Retreatment
Procedure/SurgeryConventional 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
Procedure/SurgeryRegenerative 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.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Conventional Non-Surgical Root Canal RetreatmentActive comparator 1 intervention
Group B: Regenerative Endodontic Treatment With Injectable Platelet-Rich FibrinExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline and up to 24 monthsSecondary outcomes
1
Postoperative Pain Intensity
Postoperative pain intensity will be assessed at follow-up visits using clinical evaluation and patient-reported outcomes when applicable.
Time frame
Baseline and up to 24 months2
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.
Time frame
Baseline and up to 24 months3
Pulp Vitality Response
Pulp vitality will be assessed using standardized vitality testing methods during follow-up visits to determine restoration of tooth vitality.
Time frame
Baseline and up to 24 months4
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.
Time frame
Baseline and up to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Marmara University
Lead sponsor
Marmara University Scientific Research Projects Unit
Collaborator
Source ClinicalTrials.gov