CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Blood clot scaffold +1 morebiological
Likely dose
Blood clot scaffold combined with PRF 10mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT04390854
NCT04390854Phase 2Completed

Efficacy of Combined Blood Clot and Platelet Rich Fibrin Scaffolds in Regeneration of Necrotic Immature Permanent Teeth (A Randomized Controlled Clinical Trial)

Nourhan M.Aly·interventional·Posted May 18, 2020·Updated Nov 4, 2020

In Brief

A Phase 2 clinical trial evaluating Blood clot scaffold and Blood clot scaffold combined with PRF for Pulp Necroses. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulp Necroses
CountriesEgypt

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMay 18, 2020
Enrollment StartJul 6, 2018
Primary CompletionJan 20, 2020
Study CompletionAug 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.1 years ago

Interventions

Blood clot scaffoldbiological

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.

Blood clot scaffold combined with PRFbiological

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.