Status:
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.
Lead Sponsor:
Fayoum University
Conditions:
Symptomatic Irreversible Pulpitis (SIP)
Postoperative Pain After Endodontic Treatment
Eligibility:
MALE
18-50 years
Phase:
NA
Brief Summary
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 18...
Detailed Description
Symptomatic irreversible pulpitis is a common endodontic condition characterized by severe inflammatory dental pain. Although root canal treatment (RCT) is effective in removing the inflamed pulp tiss...
Eligibility 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)
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2025
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT07239505
Start Date
August 1 2025
End Date
December 15 2025
Last Update
December 1 2025
Active Locations (1)
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1
Fayoum University
Al Fayyum, Faiyum Governorate, Egypt, 12311