Evaluation of Different Scaffolds in Regenerative Endodontic Treatment

Not Applicable

Completed

• Conditions: Endodontic Disease; Regenerative Endodontics

• Registration Number: NCT06945965
• Lead Sponsor: British University In Egypt

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-03
• Study First Submitted QC: 2025-04-22
• Last Update Submitted: 2025-04-22
• Study First Posted: 2025-04-27
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Pulp sensibility	12 months	response to the cold with ethyl chloride and/or electrical pulp testing.

Trial Locations

Locations (1)

British University in Egypt; 🇪🇬 Cairo, Egypt