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Intracanal Corticosteroid Solution for Post-Endodontic Pain Relief in Irreversible Pulpitis and Apical Periodontitis

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What is being tested

Dexamethasone

+ Placebo

DrugOther
Who is being recruted

Neurologic Manifestations+4

+ Pain

+ Pain, Postoperative

From 18 to 70 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledEarly Phase 1
Interventional
Study Start: March 2025
See protocol details

Summary

Principal SponsorUniversity of Jordan
Study ContactRenad H KhanferMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2025

Actual date on which the first participant was enrolled.

This study is focused on understanding if intentionally pushing a corticosteroid solution, specifically dexamethasone, beyond the root canal into the surrounding tissue can help reduce pain after root canal treatment. The study targets patients who have symptomatic irreversible pulpitis and symptomatic apical periodontitis, which are conditions associated with significant dental pain and inflammation. By exploring this method, the research aims to find better ways to manage pain without relying solely on traditional pain relief methods, potentially leading to improved recovery experiences for patients undergoing root canal procedures. Participants in this study will receive a root canal treatment where either a dexamethasone solution or a placebo is used. The method involves carefully allowing the solution to extend beyond the root canal into the tissues around the root. The main focus is to observe any reduction in pain levels following the procedure, comparing the effects of the corticosteroid to those of the placebo. This approach involves some degree of risk as it intentionally breaches the canal barrier, but it is closely monitored to ensure patient safety while investigating the potential benefits.

Official TitleEffect of Intentional Extrusion of an Intracanal Corticosteroid Solution on Post Endodontic Treatment Pain: a Randomized Clinical Trial
NCT06894069
Principal SponsorUniversity of Jordan
Study ContactRenad H KhanferMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsPainPain, PostoperativePathologic ProcessesPostoperative ComplicationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Criteria

3 inclusion criteria required to participate
A diagnosis of irreversible pulpits with symptomatic apical periodontitis

Adult patients (aged 18 - 70)

Healthy patients or those with a well-controlled disease (ASA I & II)

9 exclusion criteria prevent from participating
A diagnosis of necrotic pulp, or normal apical tissues

Patients with a severe systemic disease (ASA III or higher)

Patients who received analgesics12 hours before presentation

Previously treated/initiated Endodontics treatment on the same tooth

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Patients in this group will receive a standard root canal treatment but with the extra step of extruding a Dexamethasone (DXM) solution through the root canals to the periradicular tissues prior to obturation.

Group II

Placebo
Patients in this group will receive a standard root canal treatment with saline used as the final irrigating solution prior to obturation.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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