Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis

August 2, 2023 updated by: shehabeldin saber, British University In Egypt

Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis: A Randomised Control Trial

high-quality evidence is needed to add to current knowledge and also assess the long-term outcomes for full/complete pulpotomy after carious pulpal exposure in patients with signs and symptoms indicative of irreversible pulpitis

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

380

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 Contact

Study Contact Backup

Study Locations

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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • a mature permanent tooth
  • symptoms indicative of IRP
  • responsive to cold and EPT sensibility testing
  • restorable and can be adequately isolated during treatment
  • One tooth (molar or premolar) per patient.

Exclusion Criteria:

  • active periodontal disease
  • complex medical histories
  • unable to consent
  • pregnant or breast-feeding
  • excessive bleeding that cannot be controlled

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: standard root canal treatment
Procedure: vital pulp therapy
removal of the coronal pulp followed by placing a biocompatible material to preserve the vitality of the radicular pulp
Active Comparator: Pulpotomy
vital pulp therapy
Procedure: vital pulp therapy
removal of the coronal pulp followed by placing a biocompatible material to preserve the vitality of the radicular pulp

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score
Time Frame: day 3 post treatment
score by a numeric rating scale from 1(minimum pain) to 100 (maximum pain)
day 3 post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score
Time Frame: 6 months post treatment
score by a numeric rating scale from 1(minimum pain) to 100 (maximum pain)
6 months post treatment

Collaborators and Investigators

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

Sponsor

British University In Egypt

Investigators

  • Principal Investigator: shehabeldin Saber, professor of endodontics

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)

April 1, 2023

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

February 11, 2023

First Posted (Actual)

February 13, 2023

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FD BUE REC 22-034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

not to be shared

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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