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Completed

NCT Number: NCT06945965

Evaluation of Different Scaffolds in Regenerative Endodontic Treatment

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.

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Key information

Conditions

Endodontic Disease Cardiovascular Diseases Dental Pulp Diseases Embolism and Thrombosis Regenerative Endodontics Stomatognathic Diseases Thrombosis Tooth Diseases Vascular Diseases

Age range

6 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

British University in Egypt

Cairo, 1306, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Injectable platelet-rich fibrin (i-PRF) scaffold

Procedure

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)scaffold

Procedure

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) scaffold

Procedure

A sterile saline-soaked cotton pellet was placed into the canal 2 mm below the orifice for 15 minutes to form a blood clot.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Pulp sensibility

    Time frame: 12 months

    response to the cold with ethyl chloride and/or electrical pulp testing.

Sponsors and collaborators

Lead sponsor

British University In Egypt

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 27, 2025
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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