NCT07332936

Tobradex as Intracanal Medicament

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Umm Al-Qura University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Symptomatic Irreversible Pulpitis
• Postoperative Endodontic Pain Following Emergency Root Canal Treatment

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2026-01-12
• Last updated: 2026-01-13

Locations

1 site across 1 country: Saudi Arabia