Premedication on Post-endodontic Pain

Gulf Medical University

Status and phase: Enrolling; Phase 3

Conditions: Premedication

Treatments: Procedure: Root canal treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06671743

IRB-COD-STD-22-JULY-2024

Details and patient eligibility

About

The goal of this clinical trial is to compare the efficacy of preoperative administration of alpha-chemo-trypsin, ibuprofen, and acetaminophen in managing post-endodontic pain in patients with symptomatic irreversible pulpitis. The main question it aims to answer is:

What is the efficacy of preoperative administration of alpha-chemo-trypsin, ibuprofen, and acetaminophen in managing post-endodontic pain in patients with symptomatic irreversible pulpitis? Participants will undergo root canal treatment after premedication. Researchers will compare [alpha-chemo-trypsin, ibuprofen, and acetaminophen] to see the intensity of post-endodontic pain.

Enrollment: 48 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Eligibility for root canal treatment Patients diagnosed with symptomatic irreversible pulpitis with normal apical tissue in mandibular molars

Exclusion criteria

• • Patient under any medication or analgesic intake for pain management.

  • Patients with any systemic health issues
  • Patient allergies to trypsin-chymotrypsin, ibuprofen, and paracetamol
  • Pregnancy.
  • Non-restorable teeth.
  • Immature roots.
  • Calcifications.
  • Resorptions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 4 patient groups, including a placebo group

trypsin-chymotrypsin

Experimental group

Treatment:

Procedure: Root canal treatment

Ibuprofen

Active Comparator group

Treatment:

Procedure: Root canal treatment

paracetamol

Active Comparator group

Treatment:

Procedure: Root canal treatment

placebo

Placebo Comparator group

Treatment:

Procedure: Root canal treatment