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Compares treatment options for Symptomatic Irreversible Pulpitis (SIP)
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.
ClinicalTrials.gov ID: NCT07239505
What this study is testing
What is Trinase?
Trinase is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for symptomatic irreversible pulpitis (sip).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, men only
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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)
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Al Fayyum, Faiyum Governorate, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Al Fayyum, Faiyum Governorate, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.