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Completed

NCT Number: NCT07265804

PRF and CGF Scaffolds With EDTA in Regeneration

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.

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Key information

Age range

9 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kahramanmaraş Sütçü İmam University, Faculty of Dentistry

Kahramanmaraş, 46010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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 + 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.

PRF + 5% EDTA

Procedure

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

PRF + 17% EDTA

Procedure

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

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 + 17% EDTA

Procedure

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

Primary outcomes

  1. Root Length Increase

    Time frame: Baseline to 12 months

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

Secondary outcomes

  1. 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.

  2. Periapical Lesion Volume Reduction

    Time frame: Baseline to 12 months

    Volumetric reduction in periapical radiolucency measured by CBCT segmentation.

  3. Hard Tissue Formation Volume

    Time frame: Baseline to 12 months

    Increase in newly formed mineralized tissue volume assessed by CBCT 3D segmentation.

  4. Pulp Sensitivity Response

    Time frame: 12 months

    Presence or absence of a positive response to cold testing and electric pulp testing (EPT).

  5. Clinical Healing

    Time frame: Baseline, 6 months, and 12 months

    Absence of pain, swelling, sinus tract, and percussion sensitivity during follow-up examinations.

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Official study title

Current Regenerative Approaches Applied to Immature Teeth With Necrotic Pulps

Acronym: RET-EDTA-CGF

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 5, 2025
Registry last updated
Dec 12, 2025

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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