PRF Pulpotomy Using Different Bioceramic Materials in Permanent Molars

March 3, 2021 updated by: Mohamed Nageh, Fayoum University

Outcome of PRF Pulpotomy Using Different Bioceramic Materials in Permanent Molars With Irreversible Pulpitis: A Randomized Controlled Trial

this study aimed to compare the clinical and radiographic outcomes of full pulpotmy after application of Biodentine, or MTA, or Portland cement above PRF membrane In permanent molars with irreversible pulpitis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Fayoum, Egypt
        • Faculty of dentistry Fayoum University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • spontaneous, lingering pain exacerbated by hot and cold , and/or radiating pain
  • Responded to cold and electric pulp testing

Exclusion Criteria:

  • pain on palpation, percussion,
  • mobility or swelling
  • peridontall widening
  • Teeth with marginal periodontitis or crestal bone loss
  • resorption
  • calcified canals

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Portland cement
pulpotomy with PRF and white Portland cement
Procedure: portland cement
pulpotomy with PRF and white Portland cement
Experimental: Mineral trioxide aggregate
pulpotomy with PRF and Mineral trioxide aggregate
Procedure: Mineral trioxide aggregate
pulpotomy with PRF and white Mineral trioxide aggregate
Experimental: Biodentine
pulpotomy with PRF and Biodentine
Procedure: Biodentine
pulpotomy with PRF and Biodentine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in postoperative pain
Time Frame: 24 hours, 48 hours, 1 week, every 3 months for 12 months
persistence , relief , or exacerbation of pain using visual analogue scale for pain score
24 hours, 48 hours, 1 week, every 3 months for 12 months
Change in swelling
Time Frame: 24 hours, 48 hours, 1 week, every 3 months for 12 months
appearance of periapical swelling or facial swelling after the clinical procedures (Binary outcome: Yes/No)
24 hours, 48 hours, 1 week, every 3 months for 12 months
Change in Mobility
Time Frame: 24 hours, 48 hours, 1 week, every 3 months for 12 months
appearance of teeth mobility after the clinical procedures (record of periodontal pocket depth)
24 hours, 48 hours, 1 week, every 3 months for 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
calcific like bridge
Time Frame: 12 month
measure of the calcific bridge thickness using CBCT
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

March 2, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (Actual)

March 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 5, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRF Pulp

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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