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NCT Number: NCT07448571

Evaluation of Revitalization Success Using i-PRF in Non-Surgical Root Canal Retreatment

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Idil Ozden, DDS, PhD

CONTACT

[email protected]

Melike Beyza KAPLANOGLU

PRINCIPAL_INVESTIGATOR

Melike Kaplanoglu, DDS

CONTACT

[email protected]

905319330396

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Non-Surgical Root Canal Retreatment

Procedure

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

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Postoperative Pain Intensity

    Time frame: Baseline and up to 24 months

    Postoperative pain intensity will be assessed at follow-up visits using clinical evaluation and patient-reported outcomes when applicable.

  2. Percussion and Palpation Sensitivity

    Time frame: Baseline and up to 24 months

    Clinical evaluation of percussion and palpation sensitivity will be performed at scheduled follow-up visits to assess signs of persistent inflammation or tenderness.

  3. Pulp Vitality Response

    Time frame: Baseline and up to 24 months

    Pulp vitality will be assessed using standardized vitality testing methods during follow-up visits to determine restoration of tooth vitality.

  4. Proportion of Teeth With Successful Healing (PAI ≤ 2)

    Time frame: Baseline and up to 24 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Idil OZDEN, PhD

CONTACT

[email protected]

Melike B KAPLANOGLU

CONTACT

[email protected]

905319330396

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Evaluation of Revitalization Success Using i-PRF in Non-Surgical Root Canal Retreatment: A Clinical Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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