Intracanal Dexamethasone Extrusion and Postoperative Endodontic Pain

NCT06894069 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 10/2023/ 32001
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post Operative Pain Control; Endodontic Treatment

Keywords

Root canal treatment; Post-operative pain; Corticosteroids; Dexamethasone; Randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• Post-operative pain following root canal 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

  at 12, 24, 48 and 72 hours after completing the treatment

Study Arms (2)

DXM

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.

Drug: Dexamethasone

Saline

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

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

DXM

Placebo OTHER

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

Saline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Jordan: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Renad H Khanfer

CONTACT

+962795101571; renad_hazem@hotmai.com

Ahmad M El Ma'aita

CONTACT

+962799552225

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: March 25, 2025
• Study Start: March 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL