Comparative Study of the Outcome of Partial and Full Pulpotomy in Irreversible Pulpits

March 14, 2022 updated by: Jordan University of Science and Technology

Full Versus Partial Pulpotomy in the Management of Teeth With Clinical Diagnosis of Irreversible Pulpits: A Randomized Clinical Trial

This study aims at comparing the outcome of partial pulpotomy and full pulpotomy in the management of carious pulp exposures in permanent teeth with a clinical diagnosis of irreversible pulpits. The primary outcome is resolution of symptoms and the secondary outcome is clinical and radiographic normality at 1 and 2 years follow up.

The study design will be a double blind randomized clinical trial.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Aim: to compare the outcome of partial and full pulpotomy in managing carious pulp exposures in mature permanent teeth with symptoms of irreversible pulpitis

Methods: Assuming a 10% difference in the success rate in favor of pulpotomy, with 80% power and accounting for possible 10% attrition, the minimum sample size required is estimated to be 80 teeth in 80 patients in every arm.

Patients referred to the postgraduate Endodontic clinic for management of deep carious lesions with symptoms of irreversible pulpits will be assessed for inclusion in the study according to preset inclusion criteria. After a written informed consent baseline demographics of patients and teeth will be recorded.

Pulpotomy (partial or full using block randomization) will be performed under aseptic procedures and the tooth will be permanently restored. Post operative baseline radiographs will be taken.

Primary outcome will be assessed after 48 hours. secondary outcome will be assessed at 6 months, 1 year and 2 years post operatively.

Data of outcome and effect of preoperative and intraoperative variables on the outcome will be compared statistically using appropriate tests

Study Type

Interventional

Enrollment (Anticipated)

200

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

  • Jordan
      • Irbid, Jordan, 22110
        • Recruiting
        • Jordan University of Science and Technology
        • Contact:

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

10 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mature permanent tooth
  • Deep caries extending more than two thirds of dentine or exposing the pulp
  • Tooth responds positively to cold test
  • Clinical symptoms of irreversible pulpits
  • Tooth is restorable and can be restored with coronal restoration
  • Bleeding normally is confirmed after pulp exposure
  • hemostasis could be achieved within 8 minutes

Exclusion Criteria:

  • Non restorable teeth
  • necrotic teeth
  • hemostasis could not be achieved within 8 minutes

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
Active Comparator: Partial Pulpotomy
After pulp exposure 2-3 mm of the pulp tissue will be amputated, a calcium silicate based material will be placed over the pulp and the tooth will be restored.
Procedure: Partial pulpotomy
Partial pulp tissue amputation
Active Comparator: Full Pulpotomy
After pulp exposure the entire coronal pulp to the level of canal orifices will be amputated , calcium silicate based material will be placed over the pulp and the tooth will be restored.
Procedure: Full Pulpotomy
Full Pulpotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative pain level measured by visual analogy scale from 0-10
Time Frame: 48 hours
scale from 0-10
48 hours
Post operative pain level measured by a numerical scale from 0-10
Time Frame: 48 hours
scale from 0-10
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical success as measured by clinical examination
Time Frame: 6, 12, 24 months
The tooth should be pain free, no sinus tract or swelling, no tenderness to palpation as determined by clinical examination
6, 12, 24 months
Radiographic success as evaluated by periapical x-rays
Time Frame: 6, 12, 24 months
There should be no evidence of bone resorption or root resorption on the x-ray
6, 12, 24 months

Collaborators and Investigators

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

Sponsor

Jordan University of Science and Technology

Investigators

  • Study Chair: Nessrin Taha, PhD, Jordan University of Science and Technology

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)

June 1, 2021

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

November 28, 2021

First Submitted That Met QC Criteria

March 14, 2022

First Posted (Actual)

March 15, 2022

Study Record Updates

Last Update Posted (Actual)

March 15, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 329/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Until the time of completion of the study, ankylosis of data and submission for publication, then data can be provided to other researchers

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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