Comparing Trypsin-Chymotrypsin and Naproxen Sodium for Post-endodontic Treatment Pain

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-45
SponsorDow University of Health Sciences

About this trial

This study aims to compare the pain reduction efficacy of Trypsin-Chymotrypsin and Naproxen sodium after root canal treatment in patients with symptomatic irreversible pulpitis. A lot of patients suffer greatly from post endodontic treatment pain and have a fear of dental treatments due to the pain. Patients refuse to go to the dentists and neglect oral hygiene care. That's why it is very important to find an effective drug regimen to reduce this post treatment pain. The null hypothesis is that there will be no difference between the efficacy and mean pain scores of Trypsin-chymotrypsin and Naproxen Sodium for post-endodontic treatment pain. Conducted as a triple-blinded, parallel, randomized controlled trial, 100 patients will be randomly assigned to receive either Trypsin-Chymotrypsin or Naproxen sodium following standard root canal therapy. Pain levels will be assessed using a numerical rating scale at 1, 6, 12, and 24 hours post-treatment to evaluate the effectiveness of these two pain management modalities.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Both male and female, healthy patients (ASA class 1).

Patients between the age group of 18-45 years.

Patients who are appointed for endodontic treatment.

Maxillary or mandibular teeth diagnosed with symptomatic irreversible pulpitis based on delayed responses to vitality tests.

Disqualifiers

Patients who will require emergency dental treatment.

Teeth with any form of peri-apical lesion will be excluded.

Patient who have taken analgesics within 24 hours prior to the treatment.

Patients with known hypersensitivity or allergy to any of the study medications.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Trypsin-Chymotrypsin

    Drug

    100000 IU

  • Naproxen Sodium 550mg

    Drug

    550mg

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Trypsin-ChymotrypsinExperimental treatment 1 intervention
Group B: Naproxen SodiumActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in post-endodontic treatment pain score using Numeric Rating Scale

The Numeric Rating Scale (NRS-11) is an eleven-point scale that ranges from 0, indicating no pain, to 10, representing the most severe pain the patient has ever encountered.

Time frame
24 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

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