CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Chitosan scaffold/ MTA pulp dressing material +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04308863
NCT04308863Phase 2Completed

Evaluation of Chitosan Scaffold and Mineral Trioxide Aggregate Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis

Nourhan M.Aly·interventional·Posted Mar 16, 2020·Updated May 19, 2022

In Brief

A Phase 2 clinical trial evaluating Chitosan scaffold/ MTA pulp dressing material and MTA pulp dressing material for Pulpitis - Irreversible. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The aim of this study is to evaluate the clinical and radiographic outcomes of Chitosan scaffold and Mineral trioxide aggregate (MTA) when used as pulpotomy agents in mature permanent teeth with irreversible pulpitis.

Study Details

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

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMar 16, 2020
Enrollment StartNov 15, 2018
Primary CompletionOct 30, 2020
Study CompletionDec 20, 2020
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.3 years ago

Interventions

Chitosan scaffold/ MTA pulp dressing materialdrug

Chitosan 3-D porous scaffold will be prepared. The chitosan scaffolds will be examined with the Scanning electron microscopy (SEM) to analyze the surface of the chitosan scaffolds. The scaffolds will be sterilized by Ethylene oxide and stored until further use. A piece of 2-mm thick chitosan scaffold will be gently placed onto the pulp chamber floor and covering the canal orifices, and then a 2-3 mm thick layer of fast setting EndoCem Zr MTA will be applied onto the chitosan scaffold and will be gently condensed with moistened cotton pellet to attain adequate thickness which will be confirmed radiographically. MTA will be allowed to set for 4-5 mins.

MTA pulp dressing materialdrug

MTA will be gently placed over the fresh pulp wound using an MTA carrier to a thickness of 2-3 mm. It will be condensed lightly with moistened cotton pellet to attain adequate thickness and confirmed radiographically. MTA will be allowed to set for 4-5 mins.