Actively Recruiting
A Randomized Controlled Trial Evaluating Whether Pre-operative Trinase Reduces Post-operative Pain in Patients With Symptomatic Irreversible Pulpitis Compared to Placebo, Using VAS Scores and Analgesic Intake Over 48 Hours.
Led by Fayoum University · Updated on 2025-12-01
182
Participants Needed
1
Research Sites
19 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to determine whether Trinase, an enzyme-based anti-inflammatory medication, can reduce pain after root canal treatment in patients with symptomatic irreversible pulpitis. A total of 182 male patients aged 18 to 50 years who present with moderate to severe tooth pain will be randomly assigned to receive either a Trinase tablet or a placebo 30 minutes before treatment. All root canal procedures will be performed in a single visit using standard endodontic techniques. Pain levels will be measured on a Visual Analogue Scale (VAS) before treatment and at 6, 12, 24, and 48 hours after treatment. Patients will also record the number of pain-relief tablets they take during the first 48 hours. The goal of the study is to see whether Trinase can lower post-operative pain and reduce the need for analgesic medication compared with placebo. This information may help improve pain management for patients undergoing root canal therapy.
CONDITIONS
Official Title
A Randomized Controlled Trial Evaluating Whether Pre-operative Trinase Reduces Post-operative Pain in Patients With Symptomatic Irreversible Pulpitis Compared to Placebo, Using VAS Scores and Analgesic Intake Over 48 Hours.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients who are systemically healthy (ASA I or II)
- Aged between 18 and 50 years
- Diagnosed with symptomatic irreversible pulpitis in a restorable mandibular molar
- Experiencing moderate to severe preoperative pain (VAS 45 mm)
- Normal periapical tissue with no radiolucency, periodontal pocket depth 5 mm, and tooth mobility Grade I or less
You will not qualify if you...
- Medically compromised patients (ASA III or higher)
- History of allergy or intolerance to Trinase or its components (trypsin, bromelain, rutin)
- Presence of vertical root fracture
- External or internal root resorption
- Periodontal pocket depth greater than 5 mm
- Tooth mobility Grade II or III
- Presence of periapical lesion (radiolucency)
- Female patients (due to hormonal factors affecting pain perception)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fayoum University
Al Fayyum, Faiyum Governorate, Egypt, 12311
Actively Recruiting
Research Team
A
Ahmed Maged Negm, Associate Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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