CompletedNot Applicable

Tobradex as Intracanal Medicament

Saudi Arabia43 participantsStarted 2023-07-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postoperative endodontic pain intensity

Timeframe: Baseline to 48 hours post-treatment

Trial details

NCT IDNCT07332936

SponsorUmm Al-Qura University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-30

View on ClinicalTrials.gov More Symptomatic Irreversible Pulpitis trials