Periapical Bleeding Versus PRF Techniques in Regenerative Endodontic Therapy: A Randomized Controlled Trial

Comparison of Regenerative Endodontic Procedures Using Periapical Bleeding Induction, L-PRF, and I-PRF in Mature Teeth With Periapical Lesions: A Randomized Controlled Clinical Trial

This study investigates a biological approach that allows infected and necrotic teeth to heal themselves instead of being treated with traditional root canal therapy. Traditional root canal treatment involves cleaning the infected tissue inside the tooth and sealing it with a filling material, whereas regenerative endodontic treatment is a novel approach that enables the tooth to repair itself. This treatment method involves inducing bleeding in the root area or applying special blood derivatives (PRF types) to accumulate healing-supporting cells and growth factors. The aim of the study is to compare the effects of different biological treatment methods on the healing process, postoperative pain, and tooth discoloration. The results may help develop more effective and aesthetically successful treatment options in the future.

Study Overview

• Status: Completed
• Conditions: Apical Periodontitis; Necrotic Pulp; Mature Teeth; Discoloration of Teeth; Regenerative Endodontic Procedures; PRF
• Intervention / Treatment: Procedure: RVS; Procedure: L-PRF; Procedure: i-PRF

Detailed Description

This study investigates the effectiveness of regenerative endodontic procedures in the treatment of necrotic and infected teeth. Traditional root canal treatment involves the complete removal of infected tissue from inside the tooth and sealing the root canal with a biocompatible filling material. However, this method does not restore the tooth's natural vitality or protective mechanisms. Additionally, it may increase tooth fragility and lead to discoloration over time.

Regenerative endodontic treatment is a biological approach that promotes the self-healing of the tooth. This method applies tissue engineering principles to stimulate the formation of new tissue within the root canal. During the treatment process, either bleeding is induced at the root tip or special platelet-rich fibrin (PRF) derivatives are applied to facilitate the accumulation of stem cells, growth factors, and immune-boosting components that support healing.

This study compares the effects of different regenerative treatment methods (bleeding induction, L-PRF, and I-PRF applications) on lesion healing, postoperative pain, and tooth discoloration. By determining the most effective method for teeth with completed root development and apical lesions, the study aims to establish an optimal treatment protocol for clinical practice. The findings will contribute to the development of treatment options that preserve the natural structure of the tooth, enhance aesthetics, and improve patient comfort and long-term treatment success.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Etlik
    • Ankara, Etlik, Turkey, 06010
      • Gulhane Faculty of Dentistry, University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Single-rooted teeth with mature teeth with necrotic pulp requiring endodontic treatment, and a periapical lesion (Periapical Index Score (PAI) ≥3).
• Individuals without systemic diseases, not using antibiotics, corticosteroids, antidiabetic, or antihypertensive medications, and not pregnant.
• Patients without acute pain.
• Patients without extraoral swelling, sinus tract, or acute apical abscess.
• Individuals willing to participate and able to attend follow-up sessions regularly.

Exclusion Criteria:

• Teeth with internal or external root resorption or vertical root fractures.
• Immature teeth.
• Individuals outside the age range of 14-65 years.
• Patients with complicated systemic diseases or those using antibiotics, corticosteroids, antidiabetic, or antihypertensive medications.
• Patients with acute pain, those who have taken analgesic medication in the last 24 hours, or those who have used antibiotics within two weeks before treatment.
• Patients who are unlikely to attend follow-up sessions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AP; Necrotic pulped, mature teeth with apical periodontitis.	Procedure: RVS; Revascularization; Procedure: L-PRF; Regenerative endodontic procedure with L-PRF application; Procedure: i-PRF; Regenerative endodontic procedure with i-PRF application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Assessment of Lesion Healing at 6 Months	Lesion healing will be evaluated using periapical radiographs with the parallel technique, and the Periapical Index (PAI) will be used for the assessment of lesion healing.	Baseline and 6 months
Change in Pain Level at 24 Hours, 72 Hours, and 1 Week Post-Treatment	Pain levels will be assessed using the Numerical Rating Scale (NRS), ranging from 0 (no pain) to 100 (worst pain), measured at 24 hours, 72 hours, and 1 week post-procedure.	Post-Treatment at 24 Hours, 72 Hours, and 1 Week
Assessment of Tooth Discoloration at 6 Months	Tooth discoloration will be evaluated using a spectrophotometer based on the CIELab system, and teeth with a ΔE value greater than 3 will be considered discolored.	Baseline and 6 months

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2024
• Primary Completion (Actual): March 10, 2024
• Study Completion (Actual): January 24, 2025

Study Registration Dates

• First Submitted: February 13, 2025
• First Submitted That Met QC Criteria: March 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Periapical Diseases; Jaw Diseases; Dental Pulp Diseases; Tooth Diseases; Necrosis; Periodontitis; Periapical Periodontitis; Dental Pulp Necrosis; Tooth Discoloration
• Other Study ID Numbers: HKORUCU1; 2023/056 (Other Grant/Funding Number: Scientific Research Projects Coordination Unit of Health Sciences University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The impact of gender differences on pain assessment in the study was also evaluated. Additionally, the effect of age on lesion healing was analyzed. Since the study examines the effects of demographic data on lesion healing and post-treatment pain, demographic data will be shared.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No