Intracanal Dexamethasone Extrusion and Postoperative Endodontic Pain

The aim of this research is to assess the effect of intentionally extruding a corticosteroid intracanal solution into the periapical tissues on the postoperative pain after root canal treatment in patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis (SIP/SAP). The main question it aims to answer: Is there an analgesic effect of extruding an intracanal solution of DXA into the periapical tissues in patients diagnosed with SIP/SAP? Researchers will compare dexamethasone to a placebo to see if the extrusion dexamethasone works in reducing post-endodontic treatment pain.

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Key information

Conditions

Post Operative Pain Control Endodontic Treatment Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Exclusion criteria

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
Unopposed teeth
Third molar teeth
Non-restorable teeth
Periodontally compromised teeth
Pregnant or lactating patients

Treatment and study plan

Dexamethasone

Drug

a 2 ml solution of dexamethasone (3.3mg/ml) will be flushed in the root canal and intentionally extruded to the periradicular tissues to assess its potnetial sedative effect

Placebo

Other

2ml of normal saline will be used as placebo to be flushed and extruded through the canals to the periradicular tissues

Primary outcomes

Post-operative pain following root canal treatment

Time frame: at 12, 24, 48 and 72 hours after completing the treatment
The outcome measure is patient-reported pain following root canal treatment. Patients will be given a questionnaire to complete, on 4 different time intervals following the completion of their root canal treatment (12, 24, 48 and 72 h). For each time interval, patients will be asked to fill out:
- their perceived pain level on a standard 100mm visual-analogue scale, with pain values ranging from zero (no pain at all) and ascending gradually until 100 (worst imagined pain).
- Whether they needed to take any analgesics. In this case, details about the type, route, dose and timing of the analgesic taken will have to be filled out

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmad M El Ma'aita

CONTACT

+962799552225

Renad H Khanfer

CONTACT

[email protected]

+962795101571

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study title

Effect of Intentional Extrusion of an Intracanal Corticosteroid Solution on Post Endodontic Treatment Pain: a Randomized Clinical Trial

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Mar 25, 2025
Registry last updated: Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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