Pre-op Trinase to reduce pain after a one-visit root canal for symptomatic irreversible pulpitis
The Role Of Trinase In Reducing Post-Operative Pain For Patients With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
We will test whether a single Trinase tablet taken 30 minutes before a one-visit root canal reduces pain and the need for pain pills in men aged 18–50 with symptomatic irreversible pulpitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 182 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Male |
| Sponsor | Fayoum University Academic / other |
| Locations | 1 site (Al Fayyum, Faiyum Governorate) |
| Trial ID | NCT07239505 on ClinicalTrials.gov |
What this trial studies
This randomized, placebo-controlled trial will enroll 182 healthy men aged 18–50 with moderate-to-severe symptomatic irreversible pulpitis in a restorable mandibular molar. Participants will receive either a Trinase tablet or a placebo 30 minutes before a single-visit root canal performed with standard endodontic techniques. Pain will be recorded on a Visual Analogue Scale before treatment and at 6, 12, 24, and 48 hours after treatment, and patients will log any analgesic tablets taken during the first 48 hours. The trial compares post-operative pain trajectories and analgesic use between the Trinase and placebo groups to determine if pre-operative Trinase lowers early post-endodontic pain.
Who should consider this trial
Good fit: Healthy men aged 18–50 with symptomatic irreversible pulpitis in a restorable mandibular molar, preoperative VAS pain ≥45 mm, and no significant periapical or periodontal disease are the intended participants.
Not a fit: Female patients, medically compromised individuals (ASA III+), or patients with excluded dental conditions such as periapical lesions, root resorption, vertical root fracture, deep pockets, or high tooth mobility would not be expected to benefit from participation or be eligible.
Why it matters
Potential benefit: If successful, Trinase could reduce pain and the need for analgesic medication after root canal therapy, improving patient comfort and recovery.
How similar studies have performed: Proteolytic enzyme combinations (trypsin, bromelain, rutin) have shown pain and inflammation reductions in other surgical contexts, but Trinase has limited direct evidence for post-endodontic pain and has not been widely tested in this setting.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Al Fayyum, Faiyum Governorate
- Fayoum University — Al Fayyum, Faiyum Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Ahmed Maged Negm, Associate Professor
- Email: ahmed.maged@mgu.edu.eg
- Phone: 00201006600995
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.