PRF and CGF Scaffolds With EDTA in Regeneration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-10-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pulp Necrosis Immature Permanent Teeth Open Apex Periapical Periodontitis Procedure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Blood Clot + 5% EDTA

Intervention Type 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

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

Group Type EXPERIMENTAL

Blood Clot + 17% EDTA

Intervention Type 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

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

Group Type EXPERIMENTAL

PRF + 5% EDTA

Intervention Type PROCEDURE

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

PRF + 17% EDTA

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

Group Type EXPERIMENTAL

PRF + 17% EDTA

Intervention Type PROCEDURE

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

CGF + 5% EDTA

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

Group Type EXPERIMENTAL

CGF + 5% EDTA

Intervention Type PROCEDURE

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

CGF + 17% EDTA

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

Group Type EXPERIMENTAL

CGF + 17% EDTA

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

PRF + 5% EDTA

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

Intervention Type PROCEDURE

PRF + 17% EDTA

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

Intervention Type PROCEDURE

CGF + 5% EDTA

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

Intervention Type PROCEDURE

CGF + 17% EDTA

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

9 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No