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

NCT06886438 | Completed

• 2 other identifiers: HKORUCU12023/056
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Necrotic Pulp; Regenerative Endodontic Procedures; Mature Teeth; Apical Periodontitis; PRF; Discoloration of Teeth

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

AP

EXPERIMENTAL

Necrotic pulped, mature teeth with apical periodontitis.

Procedure: RVS; Procedure: L-PRF; Procedure: i-PRF

Interventions

RVS PROCEDURE

Revascularization

AP

L-PRF PROCEDURE

Regenerative endodontic procedure with L-PRF application

AP

i-PRF PROCEDURE

Regenerative endodontic procedure with i-PRF application

AP

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Gulhane Faculty of Dentistry, University of Health Sciences

Ankara, Etlik, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Pulp Necrosis; Periapical Periodontitis; Tooth Discoloration

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Periapical Diseases; Jaw Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: March 20, 2025
• Study Start: February 3, 2024
• Primary Completion: March 10, 2024
• Study Completion: January 24, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

TU (1)