Tobradex as Intracanal Medicament

NCT07332936 | Completed

• 1 other identifier: HAPO-02-K-012-2023-05-1631
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Intracanal medication; Calcium Hydroxide; Tobradex; Pain; Root canal treatment

Outcome Measures

Primary Outcomes (1)

• Postoperative endodontic pain intensity

  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

Study Arms (2)

Tobramycin-Dexamethasone (Tobradex)

EXPERIMENTAL

Participants receive a tobramycin-dexamethasone combination (Tobradex) as an intracanal medicament following standardized emergency root canal treatment for symptomatic irreversible pulpitis.

Drug: Tobramycin + Dexamethasone

Calcium Hydroxide

ACTIVE COMPARATOR

Participants receive calcium hydroxide as an intracanal medicament following standardized emergency root canal treatment for symptomatic irreversible pulpitis.

Drug: Calcium Hydroxide (Ca(OH)2)

Interventions

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.

Calcium Hydroxide

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.

Tobramycin-Dexamethasone (Tobradex)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (1)

Faculty of Dental Medicine, Umm Al-Qura University

Mecca, Saudi Arabia

Location

Related Publications (1)

• Alhilou AM, Al-Moraissi EA, Bakhsh A, Christidis N, Nasman P. Pain after emergency treatments of symptomatic irreversible pulpitis and symptomatic apical periodontitis in the permanent dentition: a systematic review of randomized clinical trials. Front Oral Health. 2023 Oct 18;4:1147884. doi: 10.3389/froh.2023.1147884. eCollection 2023.

  PMID: 37920592 RESULT

MeSH Terms

Conditions

Pain

Interventions

Calcium Hydroxide; Tobramycin, Dexamethasone Drug Combination

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes; Dexamethasone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Tobramycin; Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 12, 2026
• Study Start: July 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)