Effect of Apical Patency and Local Corticosteroid on Pain and Neuropeptides Release in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial

June 8, 2024 updated by: Mustafa M. Sultan, Suez Canal University

The goal of this randomized clinical trial is to learn the effect of using local corticosteroids and maintaining apical patency in reducing post-preparation pain in patients with acute irreversible pulpitis in molar teeth. The main question it aims to answer is:

• How effective are using local corticosteroids and maintaining apical patency in reducing post-preparation pain in patients with acute irreversible pulpitis? Participants will be asked to fill a visual analogue scale to record their pain, after receiving a root canal treatment while using local corticosteroids or not as well as maintaining apical patency or not.

Researchers will compare the use of corticosteroids and maintaining apical patency in reducing post-operative pain.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

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 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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Symptomatic acute irreversible pulpitis in molar teeth.
  • Normal periapical condition including periapical radiography with minimal widening of periodontal ligament.
  • Normal probing depth.
  • No medical condition.
  • No contraindication for administration of corticosteroids and local anesthesia.

Exclusion Criteria:

  • Facial or oral paresthesia.
  • Pregnancy & breastfeeding.
  • Unrestorable tooth.
  • Marginal periodontal disease.
  • Presence of a crown on the tooth involved.
  • Over instrumentation during root canal treatment.
  • Long-term use of corticosteroids.
  • False-positive cases of sensibility test with necrosis discovered after gaining access to the tooth.
  • Cases requiring intrapulpal injection to promote anesthesia.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: No apical patency
Procedure: Non-corticosteroid injection
no infiltration injection of 0.7 ml of dexamethasone lateral to the involved tooth after anesthesia administration.
Drug: Corticosteroid injection
infiltration injection of 0.7 ml of dexamethasone lateral to the involved tooth after anesthesia administration.
Active Comparator: Apical patency
Procedure: Non-corticosteroid injection
no infiltration injection of 0.7 ml of dexamethasone lateral to the involved tooth after anesthesia administration.
Drug: Corticosteroid injection
infiltration injection of 0.7 ml of dexamethasone lateral to the involved tooth after anesthesia administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain
Time Frame: 6, 12, 24, 48, 72 hour and 7 days postoperative intervals
Patients were instructed to record their pain level using the Visual Analog Scale
6, 12, 24, 48, 72 hour and 7 days postoperative intervals
Inflammatory markers
Time Frame: before treatment, after 3 days and after 7 days
Gingival crevicular fluid samples were collected by periopaper for testing the level of IL-1β and IL-10
before treatment, after 3 days and after 7 days

Collaborators and Investigators

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

Sponsor

Suez Canal 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)

February 1, 2021

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

June 8, 2024

First Submitted That Met QC Criteria

June 8, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 8, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 291/2020

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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