Evaluation of Different Scaffolds in Regenerative Endodontic Treatment

British University In Egypt30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Endodontic Disease Regenerative Endodontics

Interventions

Injectable platelet-rich fibrin (i-PRF) scaffoldPROCEDURE

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

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

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

British University in Egypt

Cairo, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 12 months

Secondary Outcomes

Pulp sensibility

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

Time frame: 12 months

Data from ClinicalTrials.gov

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