PRF and CGF Scaffolds With EDTA in Regeneration

NCT07265804 | Completed

• 2 other identifiers: RET-EDTA-Study-20242024/3-14 D
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Open Apex; Periapical Periodontitis; Procedure; Pulp Necrosis; Immature Permanent Teeth

Keywords

Regenerative Endodontics; Platelet-Rich Fibrin; Concentrated Growth Factor; Blood Clot Scaffold; EDTA Irrigation

Outcome Measures

Primary Outcomes (1)

• Root Length Increase

  Increase in root length measured using cone-beam computed tomography (CBCT).

  Baseline to 12 months

Secondary Outcomes (5)

• Apical Diameter Change (Apical Closure)

  Baseline to 12 months

• Periapical Lesion Volume Reduction

  Baseline to 12 months

• Hard Tissue Formation Volume

  Baseline to 12 months

• Pulp Sensitivity Response

  12 months

• Clinical Healing

  Baseline, 6 months, and 12 months

Study Arms (6)

Blood Clot + 5% EDTA

EXPERIMENTAL

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

Blood Clot + 17% EDTA

EXPERIMENTAL

Regenerative endodontic procedure using final irrigation with 17% EDTA and blood clot scaffold formation.

Procedure: Blood Clot + 17% EDTA

PRF + 5% EDTA

EXPERIMENTAL

Regenerative endodontic procedure using platelet-rich fibrin scaffold after final irrigation with 5% EDTA.

Procedure: PRF + 5% EDTA

PRF + 17% EDTA

EXPERIMENTAL

Regenerative endodontic procedure using platelet-rich fibrin scaffold following final irrigation with 17% EDTA.

Procedure: PRF + 17% EDTA

CGF + 5% EDTA

EXPERIMENTAL

Regenerative endodontic protocol using concentrated growth factor scaffold after final irrigation with 5% EDTA.

Procedure: CGF + 5% EDTA

CGF + 17% EDTA

EXPERIMENTAL

Regenerative endodontic procedure using concentrated growth factor scaffold following final irrigation with 17% EDTA.

Procedure: CGF + 17% EDTA

Interventions

Blood Clot + 17% EDTA PROCEDURE

Final irrigation with 17% EDTA followed by controlled induction of bleeding beyond the apex to produce a blood clot scaffold for regenerative endodontic treatment.

Blood Clot + 17% EDTA

PRF + 5% EDTA PROCEDURE

Application of platelet-rich fibrin (PRF) scaffold after final irrigation with 5% EDTA during regenerative endodontic therapy.

PRF + 5% EDTA

PRF + 17% EDTA PROCEDURE

Use of platelet-rich fibrin (PRF) scaffold following final irrigation with 17% EDTA in regenerative endodontic treatment.

PRF + 17% EDTA

CGF + 5% EDTA PROCEDURE

Placement of concentrated growth factor (CGF) scaffold after final irrigation with 5% EDTA as part of the regenerative endodontic protocol.

CGF + 5% EDTA

CGF + 17% EDTA PROCEDURE

Placement of concentrated growth factor (CGF) scaffold following final irrigation with 17% EDTA during regenerative endodontic treatment.

CGF + 17% EDTA

Blood Clot + 5% EDTA PROCEDURE

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.

Blood Clot + 5% EDTA

Eligibility Criteria

• Age: 9 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaraş Sütçü İmam University, Faculty of Dentistry

Kahramanmaraş, 46010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Pulp Necrosis; Periapical Periodontitis

Interventions

Blood Coagulation; Edetic Acid; Prolactin-Releasing Hormone

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

Intervention Hierarchy (Ancestors)

Hemostasis; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Aliye Kamalak

  Kahramanmaraş Sütçü İmam University, Faculty of Dentistry, Department of Endodontics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No blinding was possible because the type of scaffold (blood clot, PRF, or CGF) and the EDTA concentration (5% or 17%) were visibly identifiable during the clinical procedure. Operators could not be masked, and participants were aware of the treatment steps, making the study open label.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: This study used a parallel-group interventional model in which 30 immature permanent teeth diagnosed with pulp necrosis were randomly assigned to six treatment arms. Each participant received only one intervention, consisting of one scaffold type (blood clot, PRF, or CGF) combined with either 5% or 17% EDTA as the final irrigant. All groups were treated and followed simultaneously, and no crossover occurred between interventions.

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 5, 2025
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)