PRF and CGF Scaffolds With EDTA in Regeneration (RET-EDTA-CGF)

December 5, 2025 updated by: Aliye Kamalak, Kahramanmaras Sutcu Imam University

Current Regenerative Approaches Applied to Immature Teeth With Necrotic Pulps

This study evaluated the regenerative outcomes of immature permanent teeth with necrotic pulps treated using three scaffold types-blood clot, platelet-rich fibrin (PRF), and concentrated growth factor (CGF)-combined with either 5% or 17% EDTA as the final irrigant. Thirty teeth were randomly assigned to six treatment groups and followed clinically and radiographically for 12 months. Cone-beam computed tomography (CBCT) was used to assess root development parameters, including root length increase, apical diameter change, hard tissue formation, and periapical lesion volume. Clinical assessments included pain, swelling, sinus tract formation, percussion sensitivity, and pulp sensitivity testing. The study aimed to determine whether different scaffold materials and EDTA concentrations influence regenerative healing responses in immature necrotic teeth.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective randomized clinical study investigated regenerative endodontic treatment approaches for immature permanent teeth diagnosed with pulp necrosis and associated periapical pathology. Thirty teeth were allocated into six treatment subgroups based on two variables: scaffold type (blood clot, platelet-rich fibrin [PRF], or concentrated growth factor [CGF]) and final irrigation protocol (5% EDTA or 17% EDTA). All procedures were performed using a standardized regenerative protocol that included sodium hypochlorite irrigation, intracanal antibiotic medication, induction of apical bleeding when applicable, placement of the assigned scaffold, coronal sealing with mineral trioxide aggregate (MTA), and final composite restoration.

Radiographic evaluation involved cone-beam computed tomography (CBCT) at baseline and 12 months to measure root length development, apical diameter changes, hard tissue formation, and volumetric alterations in periapical lesions. Periapical radiographs were taken at baseline, 6 months, and 12 months to complement CBCT findings. Clinical follow-up included assessment of symptoms such as pain, swelling, sinus tract presence, tenderness to percussion, and pulp sensitivity using cold testing and electric pulp testing.

The primary aim of this study was to compare the effects of scaffold type and EDTA concentration on the biological and radiographic outcomes of regenerative endodontic treatment. The study sought to clarify how these variables may influence root maturation, apical closure, pulp vitality responses, and periapical tissue healing within a regenerative framework. This research was designed to contribute to the optimization of clinical protocols for managing immature teeth with necrotic pulps.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Kahramanmaraş, Turkey (Türkiye), 46010
        • Kahramanmaras Sutcu Imam University, Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Immature permanent teeth with open apices
  • Diagnosis of pulp necrosis
  • Radiographic evidence of periapical pathology
  • Teeth suitable for isolation and restoration
  • Patients aged 9 to 25 years
  • No systemic diseases that contraindicate dental treatment
  • Willingness to attend follow-up visits
  • Signed informed consent by patient or guardian

Exclusion Criteria:

  • Teeth with root fractures
  • Teeth with severe canal curvature (>30°)
  • Teeth with advanced root resorption
  • Periodontal pocket depth >3 mm
  • Previous endodontic treatment or retreatment
  • Pregnancy
  • Use of antibiotics or analgesics within the last 7 days
  • Nonrestorable crowns
  • Uncooperative patients unable to attend follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blood Clot + 5% EDTA
Standard regenerative endodontic treatment using final irrigation with 5% EDTA followed by induction of bleeding to form a blood clot scaffold.
Procedure: Blood Clot + 5% EDTA
Final irrigation with 5% EDTA followed by induction of apical bleeding to form an intracanal blood clot scaffold as part of the regenerative endodontic procedure.
Experimental: Blood Clot + 17% EDTA
Regenerative endodontic procedure using final irrigation with 17% EDTA and blood clot scaffold formation.
Procedure: Blood Clot + 17% EDTA
Final irrigation with 17% EDTA followed by controlled induction of bleeding beyond the apex to produce a blood clot scaffold for regenerative endodontic treatment.
Experimental: PRF + 5% EDTA
Regenerative endodontic procedure using platelet-rich fibrin scaffold after final irrigation with 5% EDTA.
Procedure: PRF + 5% EDTA
Application of platelet-rich fibrin (PRF) scaffold after final irrigation with 5% EDTA during regenerative endodontic therapy.
Experimental: PRF + 17% EDTA
Regenerative endodontic procedure using platelet-rich fibrin scaffold following final irrigation with 17% EDTA.
Procedure: PRF + 17% EDTA
Use of platelet-rich fibrin (PRF) scaffold following final irrigation with 17% EDTA in regenerative endodontic treatment.
Experimental: CGF + 5% EDTA
Regenerative endodontic protocol using concentrated growth factor scaffold after final irrigation with 5% EDTA.
Procedure: CGF + 5% EDTA
Placement of concentrated growth factor (CGF) scaffold after final irrigation with 5% EDTA as part of the regenerative endodontic protocol.
Experimental: CGF + 17% EDTA
Regenerative endodontic procedure using concentrated growth factor scaffold following final irrigation with 17% EDTA.
Procedure: CGF + 17% EDTA
Placement of concentrated growth factor (CGF) scaffold following final irrigation with 17% EDTA during regenerative endodontic treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Root Length Increase
Time Frame: Baseline to 12 months
Increase in root length measured using cone-beam computed tomography (CBCT).
Baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apical Diameter Change (Apical Closure)
Time Frame: Baseline to 12 months
Change in apical diameter measured by CBCT, used to evaluate apical closure after regenerative treatment.
Baseline to 12 months
Periapical Lesion Volume Reduction
Time Frame: Baseline to 12 months
Volumetric reduction in periapical radiolucency measured by CBCT segmentation.
Baseline to 12 months
Hard Tissue Formation Volume
Time Frame: Baseline to 12 months
Increase in newly formed mineralized tissue volume assessed by CBCT 3D segmentation.
Baseline to 12 months
Pulp Sensitivity Response
Time Frame: 12 months
Presence or absence of a positive response to cold testing and electric pulp testing (EPT).
12 months
Clinical Healing
Time Frame: Baseline, 6 months, and 12 months
Absence of pain, swelling, sinus tract, and percussion sensitivity during follow-up examinations.
Baseline, 6 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kahramanmaras Sutcu Imam University

Investigators

  • Principal Investigator: Aliye Kamalak, Kahramanmaraş Sütçü İmam University, Faculty of Dentistry, Department of Endodontics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

October 1, 2024

Study Completion (Actual)

October 1, 2024

Study Registration Dates

First Submitted

November 24, 2025

First Submitted That Met QC Criteria

November 24, 2025

First Posted (Estimated)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RET-EDTA-Study-2024
  • 2024/3-14 D (Other Grant/Funding Number: Scientific Research Projects Unit of KSU,Turkey)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD), including CBCT images and clinical records, will not be shared due to patient confidentiality and ethical restrictions stated by the institutional review board.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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