Intracanal Dexamethasone Extrusion and Postoperative Endodontic Pain

Early Phase 1

Not yet recruiting

• Conditions: Post Operative Pain Control; Endodontic Treatment
• Interventions: Drug: Dexamethasone; Other: Placebo

• Registration Number: NCT06894069
• Lead Sponsor: University of Jordan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-23
• Status Verified: 2025-03
• Study Start: 2025-03
• Study First Submitted QC: 2025-03-23
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Post-operative pain following root canal treatment	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: 1. 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).; 2. 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