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OpenTrials
Completed

NCT Number: NCT07332936

Tobradex as Intracanal Medicament

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dental Medicine, Umm Al-Qura University

Mecca, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Calcium Hydroxide (Ca(OH)2)

Drug

Calcium hydroxide is placed as an intracanal medicament after canal debridement during emergency root canal treatment as part of routine clinical practice.

Tobramycin + Dexamethasone

Drug

Tobramycin-dexamethasone (Tobradex) is placed as an intracanal medicament after canal debridement during emergency root canal treatment to reduce postoperative inflammation and pain.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Umm Al-Qura University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 12, 2026
Registry last updated
Jan 13, 2026

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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