PRF and CGF Scaffolds With EDTA in Regeneration
NCT07265804 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-12-12
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
- Pulp Necrosis
- Immature Permanent Teeth
- Open Apex
- Periapical Periodontitis
- Procedure
Interventions
- 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.
- 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.
- PROCEDURE
-
PRF + 5% EDTA
Application of platelet-rich fibrin (PRF) scaffold after final irrigation with 5% EDTA during regenerative endodontic therapy.
- PROCEDURE
-
PRF + 17% EDTA
Use of platelet-rich fibrin (PRF) scaffold following final irrigation with 17% EDTA in regenerative endodontic treatment.
- PROCEDURE
-
CGF + 5% EDTA
Placement of concentrated growth factor (CGF) scaffold after final irrigation with 5% EDTA as part of the regenerative endodontic protocol.
- PROCEDURE
-
CGF + 17% EDTA
Placement of concentrated growth factor (CGF) scaffold following final irrigation with 17% EDTA during regenerative endodontic treatment.
Sponsors & Collaborators
-
Kahramanmaras Sutcu Imam University
lead OTHER
Principal Investigators
-
Aliye Kamalak · Kahramanmaraş Sütçü İmam University, Faculty of Dentistry, Department of Endodontics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 9 Years
- Max Age
- 25 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-10-01
- Primary Completion
- 2024-10-01
- Completion
- 2024-10-01
Countries
- Turkey (Türkiye)
Study Locations
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