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

NCT04390854 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-11-04

No results posted yet for this study

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.

Conditions

  • Pulp Necroses

Interventions

BIOLOGICAL

Blood clot scaffold

Bleeding will be induced in the canal by passing a size 30 sterile K-file 3 mm beyond the apex with the goal of having the entire canal filled with blood to the level of the cemento-enamel junction. Bleeding will be stopped just below the cemento enamel junction. Biodentine will be placed approximately 3-4 mm below the cementoenamel junction.

BIOLOGICAL

Blood clot scaffold combined with PRF

Platelet-rich fibrin will be prepared by drawing the patient blood into a 10mL test tube without the addition of an anticoagulant. To prevent the blood from coagulating after coming in contact with the glass tube, it will be centrifuged immediately using a table top centrifuge\*\* at 400 g force for 12 minutes. Then platelet-rich fibrin membrane will be placed into the canal space to a level 3 mm below the cemento-enamel junction using hand plugger following the induction of apical bleeding by passing a number 30 sterile hand file 3 mm beyond the apex of the tooth. Biodentine cap will be placed over the platelet-rich fibrin scaffold.

Sponsors & Collaborators

  • Alexandria University

    collaborator OTHER

  • Nourhan M.Aly

    lead OTHER

Principal Investigators

  • Mahmoud MS Hassan, M.Sc · Faculty of Dentistry, Alexandria University, Egypt

  • Mohamed Ibrahim, PhD · Faculty of Dentistry, Alexandria University, Egypt

  • Sybel M Moussa, PhD · Faculty of Dentistry, Alexandria University, Egypt

  • Nihal A Lehita, PhD · Faculty of Dentistry, Alexandria University, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-06
Primary Completion
2020-01-20
Completion
2020-08-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04390854 on ClinicalTrials.gov