Endodontic DiseaseNCT06945965

Evaluation of Different Scaffolds in Regenerative Endodontic Treatment

A study testing Injectable platelet-rich fibrin (i-PRF) scaffold, platelet-rich fibrin (PRF)scaffold and blood clot (BC) scaffold in people with Endodontic Disease and Regenerative Endodontics, run by British University In Egypt at 1 site in Egypt.

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

The aim of this study is to evaluate and compare the regenerative potentials of Injectable Platelet-Rich Fibrin (I-PRF), Platelet-Rich Fibrin (PRF), and Blood Clot (BC) as different scaffolds regarding: Radiographic outcomes (increase of root length, increase in thickness of dentinal wall, healing of periapical… Read more about this study

Who is it for?: Ages 6 to 25 yearsHealthy volunteers can take part
Conditions the study is for: Endodontic Disease, Regenerative Endodontics
What is being tested?: Injectable platelet-rich fibrin (i-PRF) scaffold, platelet-rich fibrin (PRF)scaffold and blood clot (BC) scaffold
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteEgypt
Study dates: 1 Sep 2021to 1 Mar 2025
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 6 to 25 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Necrotic immature permanent anterior teeth.
Teeth not indicated for post/core final restoration.
Radiographically: The root has incomplete development with an apical opening of more than 1 mm.

Who cannot join

Medically compromised patients with blood and immunity disorders. Family history of autoimmune disorder. Also, patients with physical or mental handicapping conditions.
Teeth with questionable restorability of the remaining crown/root structure.
Pathological tooth mobility.
Radiographically: Evidence of root fracture or root resorption (external or internal).

Trial locations and contacts

1 site in 1 country.

Egypt1 site

British University in Egypt
Cairo, 1306

Other trials in Egypt

About this study

Official title: Evaluation of Different Scaffolds in Regenerative Endodontic Treatment of Immature Non-Vital Permanent Teeth and Their Release of Growth Factors: A Randomized Clinical Trial

Radiographic outcomes (increase of root length, increase in thickness of dentinal wall, healing of periapical lesion, and apical closure).

Clinical outcomes in the treatment of young, immature permanent teeth with necrotic pulps.

Conditions: Endodontic Disease, Regenerative Endodontics
Being tested: Injectable platelet-rich fibrin (i-PRF) scaffold, platelet-rich fibrin (PRF)scaffold, blood clot (BC) scaffold
Keywords: PRF, Regeneration, Blood Clot, Scaffolds
Medical subject headings: Dental Pulp Diseases, Thrombosis

What participants receive

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

Injectable platelet-rich fibrin (i-PRF) scaffoldProcedure or surgery
The separated plasma and platelets form a light-yellow-colored layer, which is situated at the top of the tube. This is then aspirated using a syringe with a needle (partially active injectable form).
platelet-rich fibrin (PRF)scaffoldProcedure or surgery
The fibrin clot was removed from the test tube with sterile tweezers, then cut into fragments, then placed incrementally in the canal space below the CEJ using hand pluggers (without prior induction of apical bleeding).
blood clot (BC) scaffoldProcedure or surgery
A sterile saline-soaked cotton pellet was placed into the canal 2 mm below the orifice for 15 minutes to form a blood clot.

Study groups in NCT06945965
Study group	Role	What they receive
Regeneration with Injectable platelet-rich fibrin (i-PRF) scaffold	Experimental	10 ml of venous blood was drawn from the patient's arm. Then it was collected in a sterile tube without anticoagulant. * The collected blood was centrifuged immediately. * The separated plasma and platelets form a light-yellow-colored layer, which is situated at the top of the tube. This is then aspirated using a syringe with a needle and amounts to a partially active injectable form. Receives: Procedure: Injectable platelet-rich fibrin (i-PRF) scaffold
Regeneration with platelet-rich fibrin (PRF)scaffold	Experimental	10 ml venous blood was drawn from the patient's arm * Then it was collected in a sterile tube without anticoagulant. * The collected blood was centrifuged immediately. * Following the centrifugation, the fibrin clot was formed in the middle of the tube between the red corpuscles at the bottom and acellular plasma at the top. Receives: Procedure: platelet-rich fibrin (PRF)scaffold
Regeneration with blood clot (BC) scaffold	Active comparator	The file will be passed 2 mm beyond the apical end to induce bleeding inside the canal till approximately 2-3 mm below the CEJ. Receives: Procedure: blood clot (BC) scaffold

What is being measured

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

Root Length
the distance between the CEJ and the apical endpoint mesially (M) and distally (D) on the coronal plane and labially (L) and palatally (P) on the sagittal plane. it was measured by a measure length tool in millimeters.
Measured: 12 months
Root dentine thickness
Root dentine thickness was measured as a line from the outer root canal diameter to the canal lumen in the mesial, distal, buccal, and lingual dentinal walls of the root. It was measured from the axial plane at 4 mm and 8 mm from the CEJ. It was measured by the same length-measuring tool in millimeters.
Measured: 12 months
Apical foramen diameter
It was measured as a line from the mesial and distal root ends at the coronal plane and from the labial to palatal root ends at the sagittal plane in millimeters.
Measured: 12months
Bony lesion volume
The volume of each slice of the lesion was calculated by multiplying the area of each cut by the distance of 0.5mm between the tomographic sections. With the sum of the volume of all the slices, the total volume of the bony lesion was obtained in cubic centimeters.
Measured: 12 months

Secondary outcomes (1)

Pulp sensibility
response to the cold with ethyl chloride and/or electrical pulp testing.
Measured: 12 months

Timeline

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

1 Sep 20211 Mar 2025

First posted27 Apr 2025
Study start1 Sep 2021
Primary completion1 Mar 2025
Study completion1 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Endodontic DiseaseStudies 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
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06945965
Sponsor's protocol ID: Regenerative Endodontic
Status last verified: Apr 2025
First submitted: 3 Apr 2025
Last updated: 27 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Masuki H, Okudera T, Watanebe T, Suzuki M, Nishiyama K, Okudera H, Nakata K, Uematsu K, Su CY, Kawase T. Growth factor and pro-inflammatory cytokine contents in platelet-rich plasma (PRP), plasma rich in growth factors (PRGF), advanced platelet-rich fibrin (A-PRF), and concentrated growth factors (CGF). Int J Implant Dent. 2016 Dec;2(1):19. doi: 10.1186/s40729-016-0052-4. Epub 2016 Aug 22.
PubMed 27747711
El Bagdadi K, Kubesch A, Yu X, Al-Maawi S, Orlowska A, Dias A, Booms P, Dohle E, Sader R, Kirkpatrick CJ, Choukroun J, Ghanaati S. Reduction of relative centrifugal forces increases growth factor release within solid platelet-rich-fibrin (PRF)-based matrices: a proof of concept of LSCC (low speed centrifugation concept). Eur J Trauma Emerg Surg. 2019 Jun;45(3):467-479. doi: 10.1007/s00068-017-0785-7. Epub 2017 Mar 21.
PubMed 28324162
Metlerska J, Fagogeni I, Nowicka A. Efficacy of Autologous Platelet Concentrates in Regenerative Endodontic Treatment: A Systematic Review of Human Studies. J Endod. 2019 Jan;45(1):20-30.e1. doi: 10.1016/j.joen.2018.09.003. Epub 2018 Nov 13.
PubMed 30446403
Murray PE. Platelet-Rich Plasma and Platelet-Rich Fibrin Can Induce Apical Closure More Frequently Than Blood-Clot Revascularization for the Regeneration of Immature Permanent Teeth: A Meta-Analysis of Clinical Efficacy. Front Bioeng Biotechnol. 2018 Oct 11;6:139. doi: 10.3389/fbioe.2018.00139. eCollection 2018.
PubMed 30364277

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

Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
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 recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
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

All Endodontic Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Different Scaffolds in Regenerative Endodontic Treatment of Immature Non-Vital Permanent Teeth and Their Release of Growth Factors: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT06945965
Acronym / sponsor ID: Regenerative Endodontic
Conditions: Endodontic Disease, Regenerative Endodontics
Keywords: PRF, Regeneration, Blood Clot, Scaffolds
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: British University In EgyptUniversity, hospital or other
Study start: 1 Sep 2021 (actual)
Primary completion: 1 Mar 2025 (actual)
Study completion: 1 Mar 2025 (actual)
First posted: 27 Apr 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.

Radiographic outcomes (increase of root length, increase in thickness of dentinal wall, healing of periapical lesion, and apical closure).

Clinical outcomes in the treatment of young, immature permanent teeth with necrotic pulps.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Regeneration with Injectable platelet-rich fibrin (i-PRF) scaffold	Experimental	Procedure: Injectable platelet-rich fibrin (i-PRF) scaffold10 ml of venous blood was drawn from the patient's arm. Then it was collected in a sterile tube without anticoagulant. * The collected blood was centrifuged immediately. * The separated plasma and platelets form a light-yellow-colored layer, which is situated at the top of the tube. This is then aspirated using a syringe with a needle and amounts to a partially active injectable form.
Regeneration with platelet-rich fibrin (PRF)scaffold	Experimental	Procedure: platelet-rich fibrin (PRF)scaffold10 ml venous blood was drawn from the patient's arm * Then it was collected in a sterile tube without anticoagulant. * The collected blood was centrifuged immediately. * Following the centrifugation, the fibrin clot was formed in the middle of the tube between the red corpuscles at the bottom and acellular plasma at the top.
Regeneration with blood clot (BC) scaffold	Active comparator	Procedure: blood clot (BC) scaffoldThe file will be passed 2 mm beyond the apical end to induce bleeding inside the canal till approximately 2-3 mm below the CEJ.

Who may qualify

Ages: 6 to 25 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Necrotic immature permanent anterior teeth.
Teeth not indicated for post/core final restoration.
Radiographically: The root has incomplete development with an apical opening of more than 1 mm.

Key exclusion criteria (4 listed)

Medically compromised patients with blood and immunity disorders. Family history of autoimmune disorder. Also, patients with physical or mental handicapping conditions.
Teeth with questionable restorability of the remaining crown/root structure.
Pathological tooth mobility.
Radiographically: Evidence of root fracture or root resorption (external or internal).

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
Injectable platelet-rich fibrin (i-PRF) scaffoldThe separated plasma and platelets form a light-yellow-colored layer, which is situated at the top of the tube. This is then aspirated using a syringe with a needle (partially active injectable form).	Procedure or surgery	Regeneration with Injectable platelet-rich fibrin (i-PRF) scaffold
platelet-rich fibrin (PRF)scaffoldThe fibrin clot was removed from the test tube with sterile tweezers, then cut into fragments, then placed incrementally in the canal space below the CEJ using hand pluggers (without prior induction of apical bleeding).	Procedure or surgery	Regeneration with platelet-rich fibrin (PRF)scaffold
blood clot (BC) scaffoldA sterile saline-soaked cotton pellet was placed into the canal 2 mm below the orifice for 15 minutes to form a blood clot.	Procedure or surgery	Regeneration with blood clot (BC) scaffold

Primary outcome

Root Length
Time frame: 12 months
the distance between the CEJ and the apical endpoint mesially (M) and distally (D) on the coronal plane and labially (L) and palatally (P) on the sagittal plane. it was measured by a measure length tool in millimeters.
Root dentine thickness
Time frame: 12 months
Root dentine thickness was measured as a line from the outer root canal diameter to the canal lumen in the mesial, distal, buccal, and lingual dentinal walls of the root. It was measured from the axial plane at 4 mm and 8 mm from the CEJ. It was measured by the same length-measuring tool in millimeters.
Apical foramen diameter
Time frame: 12months
It was measured as a line from the mesial and distal root ends at the coronal plane and from the labial to palatal root ends at the sagittal plane in millimeters.
Bony lesion volume
Time frame: 12 months
The volume of each slice of the lesion was calculated by multiplying the area of each cut by the distance of 0.5mm between the tomographic sections. With the sum of the volume of all the slices, the total volume of the bony lesion was obtained in cubic centimeters.

1 secondary outcome

Pulp sensibility
Time frame: 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 27 Apr 2025.
Background: PubMed 27747711Masuki H, Okudera T, Watanebe T, Suzuki M, Nishiyama K, Okudera H, Nakata K, Uematsu K, Su CY, Kawase T. Growth factor and pro-inflammatory cytokine contents in platelet-rich plasma (PRP), plasma rich in growth factors (PRGF), advanced platelet-rich fibrin (A-PRF), and concentrated growth factors (CGF). Int J Implant Dent. 2016 Dec;2(1):19. doi: 10.1186/s40729-016-0052-4. Epub 2016 Aug 22.
Background: PubMed 28324162El Bagdadi K, Kubesch A, Yu X, Al-Maawi S, Orlowska A, Dias A, Booms P, Dohle E, Sader R, Kirkpatrick CJ, Choukroun J, Ghanaati S. Reduction of relative centrifugal forces increases growth factor release within solid platelet-rich-fibrin (PRF)-based matrices: a proof of concept of LSCC (low speed centrifugation concept). Eur J Trauma Emerg Surg. 2019 Jun;45(3):467-479. doi: 10.1007/s00068-017-0785-7. Epub 2017 Mar 21.
Background: PubMed 30446403Metlerska J, Fagogeni I, Nowicka A. Efficacy of Autologous Platelet Concentrates in Regenerative Endodontic Treatment: A Systematic Review of Human Studies. J Endod. 2019 Jan;45(1):20-30.e1. doi: 10.1016/j.joen.2018.09.003. Epub 2018 Nov 13.
Background: PubMed 30364277Murray PE. Platelet-Rich Plasma and Platelet-Rich Fibrin Can Induce Apical Closure More Frequently Than Blood-Clot Revascularization for the Regeneration of Immature Permanent Teeth: A Meta-Analysis of Clinical Efficacy. Front Bioeng Biotechnol. 2018 Oct 11;6:139. doi: 10.3389/fbioe.2018.00139. eCollection 2018.
Individual participant dataSharing planned: No

Related trials for Endodontic Disease

Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
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
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Not yet recruitingPhase 3
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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

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.

shehab M Mohamed, Phd study director

British University In Egypt

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 3 inclusion and 4 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 27 Apr 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 Egypt. 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 (time frame: 12 months). The study lists 4 primary outcomes in all. 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 NCT06945965, which also lists 4 linked publications.

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 27 Apr 2025.