Pulp NecrosisRET-EDTA-CGFNCT07265804

PRF and CGF Scaffolds With EDTA in Regeneration

A study testing Blood Clot + 5% EDTA, Blood Clot + 17% EDTA and PRF + 5% EDTA in people with Pulp Necrosis and Immature Permanent Teeth, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 9 to 25 years
Conditions the study is for: Pulp Necrosis, Immature Permanent Teeth, Open Apex
What is being tested?: Blood Clot + 5% EDTA, Blood Clot + 17% EDTA and PRF + 5% EDTA
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Oct 2023to 1 Oct 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 9 to 25 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

Use of antibiotics or analgesics within the last 7 days
Nonrestorable crowns
Uncooperative patients unable to attend follow-up

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Kahramanmaraş Sütçü İmam University, Faculty of Dentistry
Kahramanmaraş, 46010

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Conditions: Pulp Necrosis, Immature Permanent Teeth, Open Apex, Periapical Periodontitis, Procedure
Being tested: Blood Clot + 5% EDTA, Blood Clot + 17% EDTA, PRF + 5% EDTA, PRF + 17% EDTA, CGF + 5% EDTA
Keywords: Regenerative Endodontics, Platelet-Rich Fibrin, Concentrated Growth Factor, Blood Clot Scaffold, EDTA Irrigation
Medical subject headings: Dental Pulp Necrosis, Periapical Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood Clot + 5% EDTAProcedure or surgery
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% EDTAProcedure or surgery
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% EDTAProcedure or surgery
Application of platelet-rich fibrin (PRF) scaffold after final irrigation with 5% EDTA during regenerative endodontic therapy.
PRF + 17% EDTAProcedure or surgery
Use of platelet-rich fibrin (PRF) scaffold following final irrigation with 17% EDTA in regenerative endodontic treatment.
CGF + 5% EDTAProcedure or surgery
Placement of concentrated growth factor (CGF) scaffold after final irrigation with 5% EDTA as part of the regenerative endodontic protocol.
CGF + 17% EDTAProcedure or surgery
Placement of concentrated growth factor (CGF) scaffold following final irrigation with 17% EDTA during regenerative endodontic treatment.

Study groups in NCT07265804
Study group	Role	What they receive
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. Receives: Procedure: Blood Clot + 5% EDTA
Blood Clot + 17% EDTA	Experimental	Regenerative endodontic procedure using final irrigation with 17% EDTA and blood clot scaffold formation. Receives: Procedure: Blood Clot + 17% EDTA
PRF + 5% EDTA	Experimental	Regenerative endodontic procedure using platelet-rich fibrin scaffold after final irrigation with 5% EDTA. Receives: Procedure: PRF + 5% EDTA
PRF + 17% EDTA	Experimental	Regenerative endodontic procedure using platelet-rich fibrin scaffold following final irrigation with 17% EDTA. Receives: Procedure: PRF + 17% EDTA
CGF + 5% EDTA	Experimental	Regenerative endodontic protocol using concentrated growth factor scaffold after final irrigation with 5% EDTA. Receives: Procedure: CGF + 5% EDTA
CGF + 17% EDTA	Experimental	Regenerative endodontic procedure using concentrated growth factor scaffold following final irrigation with 17% EDTA. Receives: Procedure: CGF + 17% EDTA

What is being measured

The primary outcome is the main question the study is designed to answer.

Root Length Increase
Increase in root length measured using cone-beam computed tomography (CBCT).
Measured: Baseline to 12 months

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20231 Oct 2024

First posted5 Dec 2025
Study start1 Oct 2023
Primary completion1 Oct 2024
Study completion1 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pulp NecrosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07265804
Sponsor's protocol ID: RET-EDTA-Study-2024
Other IDs: 2024/3-14 D
Acronym: RET-EDTA-CGF
Status last verified: Dec 2025
First submitted: 24 Nov 2025
Last updated: 12 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
Necrotic Pulps With no Apical Periodontitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
Pulp Necrosis, Apical Periodontitis

All Pulp Necrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Current Regenerative Approaches Applied to Immature Teeth With Necrotic Pulps
ClinicalTrials.gov ID: NCT07265804
Acronym / sponsor ID: RET-EDTA-CGF / RET-EDTA-Study-2024
Conditions: Pulp Necrosis, Immature Permanent Teeth, Open Apex, Periapical Periodontitis, Procedure
Keywords: Regenerative Endodontics, Platelet-Rich Fibrin, Concentrated Growth Factor, Blood Clot Scaffold, EDTA Irrigation
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
Study start: 1 Oct 2023 (actual)
Primary completion: 1 Oct 2024 (actual)
Study completion: 1 Oct 2024 (actual)
First posted: 5 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6
Model description: 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.

Arm	Type	Receives
Blood Clot + 5% EDTA	Experimental	Procedure: Blood Clot + 5% EDTAStandard regenerative endodontic treatment using final irrigation with 5% EDTA followed by induction of bleeding to form a blood clot scaffold.
Blood Clot + 17% EDTA	Experimental	Procedure: Blood Clot + 17% EDTARegenerative endodontic procedure using final irrigation with 17% EDTA and blood clot scaffold formation.
PRF + 5% EDTA	Experimental	Procedure: PRF + 5% EDTARegenerative endodontic procedure using platelet-rich fibrin scaffold after final irrigation with 5% EDTA.
PRF + 17% EDTA	Experimental	Procedure: PRF + 17% EDTARegenerative endodontic procedure using platelet-rich fibrin scaffold following final irrigation with 17% EDTA.
CGF + 5% EDTA	Experimental	Procedure: CGF + 5% EDTARegenerative endodontic protocol using concentrated growth factor scaffold after final irrigation with 5% EDTA.
CGF + 17% EDTA	Experimental	Procedure: CGF + 17% EDTARegenerative endodontic procedure using concentrated growth factor scaffold following final irrigation with 17% EDTA.

Who may qualify

Ages: 9 to 25 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Blood Clot + 5% EDTAFinal 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 or surgery	Blood Clot + 5% EDTA
Blood Clot + 17% EDTAFinal irrigation with 17% EDTA followed by controlled induction of bleeding beyond the apex to produce a blood clot scaffold for regenerative endodontic treatment.	Procedure or surgery	Blood Clot + 17% EDTA
PRF + 5% EDTAApplication of platelet-rich fibrin (PRF) scaffold after final irrigation with 5% EDTA during regenerative endodontic therapy.	Procedure or surgery	PRF + 5% EDTA
PRF + 17% EDTAUse of platelet-rich fibrin (PRF) scaffold following final irrigation with 17% EDTA in regenerative endodontic treatment.	Procedure or surgery	PRF + 17% EDTA
CGF + 5% EDTAPlacement of concentrated growth factor (CGF) scaffold after final irrigation with 5% EDTA as part of the regenerative endodontic protocol.	Procedure or surgery	CGF + 5% EDTA
CGF + 17% EDTAPlacement of concentrated growth factor (CGF) scaffold following final irrigation with 17% EDTA during regenerative endodontic treatment.	Procedure or surgery	CGF + 17% EDTA

Primary outcome

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

5 secondary outcomes

Apical Diameter Change (Apical Closure)
Time frame: Baseline to 12 months
Periapical Lesion Volume Reduction
Time frame: Baseline to 12 months
Hard Tissue Formation Volume
Time frame: Baseline to 12 months
Pulp Sensitivity Response
Time frame: 12 months
Clinical Healing
Time frame: Baseline, 6 months, and 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
Individual participant dataSharing planned: No. 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.

Related trials for Pulp Necrosis

Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
Necrotic Pulps With no Apical Periodontitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
Pulp Necrosis, Apical Periodontitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Aliye Kamalak principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Root Length Increase (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07265804.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.