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

NCT04308863 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-05-19

No results posted yet for this study

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.

Conditions

  • Pulpitis - Irreversible

Interventions

DRUG

Chitosan scaffold/ MTA pulp dressing material

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.

DRUG

MTA pulp dressing material

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.

Sponsors & Collaborators

  • Alexandria University

    collaborator OTHER

  • Nourhan M.Aly

    lead OTHER

Principal Investigators

  • Maha T Aboul Kheir, M.Sc · Faculty of Dentistry, Alexandria University, Egypt

  • Rania M ElBackly, PhD · Faculty of Dentistry, Alexandria University, Egypt

  • Raef Sherif, PhD · Faculty of Dentistry, Alexandria University, Egypt

  • Yasser Elkamary · European Egyptian Pharmaceutical Industries, Pharco Corporation, Alexandria, Egypt

  • Nayera Mokhless, PhD · Faculty of Dentistry, Alexandria University, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-15
Primary Completion
2020-10-30
Completion
2020-12-20

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 NCT04308863 on ClinicalTrials.gov