Tobradex as Intracanal Medicament

January 10, 2026 updated by: Abdulaziz Bakhsh, Umm Al-Qura University

Effect of Calcium Hydroxide vs. Tobradex Intracanal Medicament on Postoperative Endodontic Pain: A Prospective Trial

The goal of this prospective clinical study was to evaluate and compare the short-term effects of two intracanal medicaments-calcium hydroxide and a tobramycin-dexamethasone combination (Tobradex)-on postoperative pain following emergency root canal treatment in adult patients with symptomatic irreversible pulpitis.

The main question it aimed to answer was:

Does Tobradex reduce postoperative endodontic pain more effectively than calcium hydroxide within the first 48 hours after emergency root canal treatment? Adult patients presenting with acute dental pain and already receiving emergency root canal therapy as part of their routine clinical care were included. After canal debridement, patients received either calcium hydroxide or Tobradex as an intracanal medicament based on availability at the time of treatment. Participants reported their pain intensity using a numeric rating scale before treatment and again at 24 and 48 hours following the procedure. Pain outcomes were compared between groups, and the influence of demographic factors such as age and gender was also explored.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective clinical study investigates the effect of two commonly used intracanal medicaments-calcium hydroxide and a tobramycin-dexamethasone combination (Tobradex)-on postoperative pain following emergency root canal treatment. Postoperative pain remains a frequent concern after endodontic emergency procedures, particularly in teeth diagnosed with symptomatic irreversible pulpitis. While calcium hydroxide is widely used for its antimicrobial properties, evidence regarding its effectiveness in pain control is inconsistent. In contrast, intracanal medicaments containing corticosteroids have shown promise in reducing inflammation-related pain, yet limited clinical data are available for alternative steroid-antibiotic formulations such as Tobradex.

Patients presenting with acute endodontic pain and requiring emergency root canal treatment received standardized clinical care. Following canal debridement and irrigation, an intracanal medicament was placed, and the access cavity was temporized. The choice of medicament depended on availability during the emergency visit, reflecting real-world clinical practice. Pain intensity was assessed using a numeric rating scale at baseline and during the early postoperative period, allowing evaluation of both immediate and short-term pain reduction.

The primary focus of the study was to compare the magnitude and timing of pain relief achieved by the two medicaments within the first 48 hours after treatment. Secondary objectives included exploring whether patient-related factors, such as age or gender, influenced postoperative pain reduction. By examining pain outcomes during this critical early period, the study aims to clarify the potential benefit of incorporating a corticosteroid-antibiotic combination as an intracanal medicament in emergency endodontic care.

The findings of this study are intended to inform clinical decision-making regarding inter-appointment pain management and to provide preliminary evidence supporting alternative intracanal medicament strategies that prioritize patient comfort without compromising antimicrobial control.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Mecca, Saudi Arabia
        • Faculty of Dental Medicine, Umm Al-Qura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18 years or older
  • Patients presenting with acute dental pain diagnosed as symptomatic irreversible pulpitis
  • Teeth requiring emergency root canal treatment
  • Ability to understand and provide informed consent
  • Willingness to report pain levels during the follow-up period

Exclusion Criteria:

  • Presence of acute or chronic apical abscess requiring systemic antibiotic therapy
  • Teeth with previous root canal treatment
  • Patients with systemic conditions that may affect healing or pain perception (e.g., uncontrolled diabetes, immunocompromised status)
  • Known allergy or hypersensitivity to calcium hydroxide, tobramycin, dexamethasone, or related compounds
  • Pregnant or lactating women

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tobramycin-Dexamethasone (Tobradex)
Participants receive a tobramycin-dexamethasone combination (Tobradex) as an intracanal medicament following standardized emergency root canal treatment for symptomatic irreversible pulpitis.
Drug: Tobramycin + Dexamethasone
Tobramycin-dexamethasone (Tobradex) is placed as an intracanal medicament after canal debridement during emergency root canal treatment to reduce postoperative inflammation and pain.
Active Comparator: Calcium Hydroxide
Participants receive calcium hydroxide as an intracanal medicament following standardized emergency root canal treatment for symptomatic irreversible pulpitis.
Drug: Calcium Hydroxide (Ca(OH)2)
Calcium hydroxide is placed as an intracanal medicament after canal debridement during emergency root canal treatment as part of routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative endodontic pain intensity
Time Frame: Baseline to 48 hours post-treatment
Pain intensity measured using a numeric rating scale (0-10) at baseline, 24 hours, and 48 hours following intracanal medicament placement.
Baseline to 48 hours post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umm Al-Qura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

December 30, 2025

First Submitted That Met QC Criteria

December 30, 2025

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 10, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAPO-02-K-012-2023-05-1631

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data collected during this study will not be shared publicly. Aggregate, de-identified results will be reported through publications and presentations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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