Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
43 participants
INTERVENTIONAL
2023-07-01
2024-06-30
Brief Summary
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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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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Tobramycin-Dexamethasone (Tobradex)
Participants receive a tobramycin-dexamethasone combination (Tobradex) as an intracanal medicament following standardized emergency root canal treatment for symptomatic irreversible pulpitis.
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.
Calcium Hydroxide
Participants receive calcium hydroxide as an intracanal medicament following standardized emergency root canal treatment for symptomatic irreversible pulpitis.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Umm Al-Qura University
OTHER
Responsible Party
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Abdulaziz Bakhsh
Assistant Professor
Locations
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Faculty of Dental Medicine, Umm Al-Qura University
Mecca, , Saudi Arabia
Countries
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References
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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.
Other Identifiers
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HAPO-02-K-012-2023-05-1631
Identifier Type: -
Identifier Source: org_study_id
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