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Evaluation of Different Scaffolds in Regenerative Endodontic Treatment

B

British University In Egypt

Status

Completed

Conditions

Endodontic Disease
Regenerative Endodontics

Treatments

Procedure: Injectable platelet-rich fibrin (i-PRF) scaffold
Procedure: platelet-rich fibrin (PRF)scaffold
Procedure: blood clot (BC) scaffold

Study type

Interventional

Funder types

Other

Identifiers

NCT06945965
Regenerative Endodontic

Details and patient eligibility

About

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 lesion, and apical closure).

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

Enrollment

30 patients

Sex

All

Ages

6 to 25 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 3 patient groups

Regeneration with Injectable platelet-rich fibrin (i-PRF) scaffold
Experimental group
Description:
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.
Treatment:
Procedure: Injectable platelet-rich fibrin (i-PRF) scaffold
Regeneration with platelet-rich fibrin (PRF)scaffold
Experimental group
Description:
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.
Treatment:
Procedure: platelet-rich fibrin (PRF)scaffold
Regeneration with blood clot (BC) scaffold
Active Comparator group
Description:
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.
Treatment:
Procedure: blood clot (BC) scaffold

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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