Endodontic Disease, Regenerative Endodontics
Conditions
Keywords
PRF, Regeneration, Blood Clot, Scaffolds
Brief 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 lesion, and apical closure). Clinical outcomes in the treatment of young, immature permanent teeth with necrotic pulps.
Interventions
PROCEDUREInjectable platelet-rich fibrin (i-PRF) scaffold
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).
PROCEDUREplatelet-rich fibrin (PRF)scaffold
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).
PROCEDUREblood clot (BC) scaffold
A sterile saline-soaked cotton pellet was placed into the canal 2 mm below the orifice for 15 minutes to form a blood clot.
Sponsors
British University In Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The trial design of this study is planned to be a double-blinded design in which the participant and the statistician will be blinded, and only the operator knows which treatment the patient will receive.
Eligibility
Sex/Gender
ALL
Age
6 Years to 25 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Root Length | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Pulp sensibility | 12 months | response to the cold with ethyl chloride and/or electrical pulp testing. |
Countries
Egypt
Outcome results
None listed