New enzyme pill may ease root canal pain
NCT ID NCT07239505
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether Trinase, an enzyme-based anti-inflammatory medication, can reduce pain after root canal treatment. 182 men with moderate to severe tooth pain will receive either Trinase or a placebo 30 minutes before the procedure. Pain levels and the need for extra painkillers will be tracked for 48 hours after treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 182 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Dec 2025
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 50 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Systemically healthy male patients (ASA I or II) * Aged 18 to 50 years * Presenting with symptomatic irreversible pulpitis in a restorable mandibular molar * Preoperative moderate to severe pain (VAS ≥45 mm) * Normal periapical tissue (no radiolucency, pocket depth ≤5 mm, mobility ≤ Grade I) Exclusion Criteria: Medically compromised patients (ASA III or higher) * History of allergy or intolerance to Trinase or any of its components (trypsin, bromelain, rutin) * Vertical root fracture * External or internal root resorption * Periodontal pocket depth \>5 mm * Tooth mobility Grade II or III * Presence of periapical lesion (radiolucency) * Female patients (to standardize pain perception and hormonal factors)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
Locations
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Fayoum University
RECRUITINGAl Fayyum, Faiyum Governorate, 12311, Egypt
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