Intracanal Dexamethasone Extrusion and Postoperative Endodontic Pain

NCT ID: NCT06894069

Last Updated: 2025-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2025-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post Operative Pain Control Endodontic Treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DXM

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 Type EXPERIMENTAL

Dexamethasone

Intervention Type 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

Saline

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexamethasone

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Jordan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Renad Hazem Khanfer

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Renad H Khanfer

Role: CONTACT

+962795101571

Ahmad M El Ma'aita

Role: CONTACT

+962799552225

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10/2023/ 32001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.