Post Operative Pain of Partial Pulpotomy Using a Bioceramic Material in Patients With Symptomatic Irreversible Pulpitis

May 12, 2024 updated by: Mohamed Omaia Ahmed Salah, October 6 University

Evaluation of Postoperative Pain After Partial Pulpotomy Versus Full Root Canal Treatment in Managing Young Permanent Molars With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial

The goal of this clinical trial is to assess post-operative pain of partial pulpotomy using a newly introduced Bioceramic material in young patients with symptomatic irreversible pulpitis at 24, 48, 72 hours postoperatively using visual analogue scale (VAS). The main question[s] it aims to answer are:

• In patients with symptomatic irreversible pulpitis does the use of bioceramic material in partial pulpotomy decrease amount of post operative pain in comparison to conventional root canal treatment?

Participants will record the intensity of pain at 24,48, 72 hours postoperatively.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Early Phase 1

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
      • Giza, Egypt, 12573
        • Faculty of Dentistry, October 6 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

  • Child

Accepts Healthy Volunteers

Yes

Description

  1. Inclusion criteria :

    1. Subject's age between 9-14 years.
    2. Both male and female subjects.
    3. Medically free and healthy subjects.
    4. Mandibular molar teeth.
    5. Teeth with symptomatic irreversible pulpitis.
    6. Teeth with mature closed apices.

  2. Exclusion Criteria:

    1. Teeth with acute dentoalveolar abscess.
    2. Subjects having more than one tooth that require root canal treatment.
    3. Subjects that have taken analgesic, anti-inflammatory or antibiotic drugs during the 10 days prior to the start of treatment.
    4. Subjects with systemic diseases who have endocrine diseases, Infectious diseases or Psychological disturbance.
    5. Teeth with periodontal disease or pulp calcification.
    6. Subjects taking chronic pain medications.

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
No Intervention: Control: conventional root canal treatment
Other: Test: partial pulpotomy
Partial pulpotomy using bioceramic putty
Procedure: Partial pulpotomy
Use of newly introduced bioceramic putty in partial pulpotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative pain
Time Frame: after 24 hours
Measure intensity of post operative pain using visual analogue scale (VAS)
after 24 hours
Post operative pain
Time Frame: after 48 hours
Measure intensity of post operative pain using visual analogue scale (VAS)
after 48 hours
Post operative pain
Time Frame: After 72 hours
Measure intensity of post operative pain using visual analogue scale (VAS)
After 72 hours

Collaborators and Investigators

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

Sponsor

October 6 University

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, 2023

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

October 22, 2023

Study Registration Dates

First Submitted

July 7, 2023

First Submitted That Met QC Criteria

July 13, 2023

First Posted (Actual)

July 21, 2023

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 12, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECO6U/27-2023

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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