Efficacy of Combined Blood Clot and Platelet Rich Fibrin Scaffolds in Regeneration of Necrotic Immature Permanent Teeth

Phase 2

Completed

• Conditions: Pulp Necroses
• Interventions: Biological: Blood clot scaffold combined with PRF; Biological: Blood clot scaffold

• Registration Number: NCT04390854
• Lead Sponsor: Nourhan M.Aly

Brief Summary

The aim of the present study is to assess clinically and radio-graphically the regenerative potential of immature permanent teeth with necrotic pulp using blood clot and Platelet rich fibrin scaffolds.

Detailed Description

30 immature necrotic permanent teeth in patients will be allocated and divided into two groups. Group 1 will be treated by regenerative procedure using blood clot as a scaffold and Group 2 will be treated with regenerative procedures using combined blood clot and Platelet rich fibrin as a scaffold.

Study Timeline

• Study Start: 2018-07-06
• Primary Completion: 2020-01-20
• Study First Submitted: 2020-05-08
• Study First Submitted QC: 2020-05-14
• Study First Posted: 2020-05-18
• Study Completion: 2020-08-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

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

Inclusion Criteria

• Necrotic incisors with immature roots
• Pulp space not needed for post and core.
• The patient has to be free from any coagulation disorders, with normal platelets count.
• Good oral hygiene
• Cooperative patient

Exclusion Criteria

• Internal or external root resorption.
• Root fracture and/or alveolar fracture.
• Previous root canal treatment.
• Medically compromised patients
• Uncooperative patient

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Induced blood clot scaffold combined with Platelet rich fibrin	Blood clot scaffold combined with PRF	-
Induced blood clot scaffold	Blood clot scaffold	-

Primary Outcome Measures

Name	Time	Method
Assessment of pulp vitality	12 months	Pulp vitality will be assessed using thermal and electric pulp sensibility tests
Assessment of the size of periapical radiolucency	12 months	Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).
Subjective pain assessment	12 months	The patient will be asked about the presence of any pain or discomfort. Pain severity will be categorized as: no pain - mild pain - moderate pain - severe pain
Assessment of root development	12 months	Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt