Actively Recruiting

Phase 4
Age: 18Years - 45Years
All Genders
Healthy Volunteers
ID06562816

Comparing Trypsin-Chymotrypsin and Naproxen Sodium for Post-endodontic Treatment Pain: a Randomized Controlled Trial

Led by Dow University of Health Sciences · Updated on 2024-11-04

100

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the pain reduction effects of Trypsin-Chymotrypsin compared to Naproxen Sodium in patients with symptomatic irreversible pulpitis after root canal treatment. This study addresses the issue of significant post-treatment pain that often causes patients to avoid dental care, aiming to find an effective pain management option. Conducted as a triple-blinded, randomized controlled trial, it seeks to determine if there is any difference in pain relief between these two medications. The trial includes 100 patients randomly assigned to two groups: one receives Trypsin-Chymotrypsin tablets three times a day before meals for 24 hours, while the other group takes Naproxen Sodium 550mg twice a day after meals for 24 hours. Both treatments follow standard root canal therapy. The medications are given in sealed envelopes to maintain blinding and reduce bias. Participants will report their pain levels using a numerical rating scale at 1, 6, 12, and 24 hours after treatment. Researchers will monitor and compare the change in pain scores between the two groups over this period. The study is designed to minimize bias with computer-generated randomization and quadruple masking, ensuring reliable results about the effectiveness of these pain management options after endodontic treatment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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.
  • Patients with any systemic disease such as uncontrolled diabetes, gastric ulcers, bleeding disorders, or cardiovascular problems.
  • Pregnant or lactating women and pediatric patients.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 24 hours

Participants receive either Trypsin-Chymotrypsin or Naproxen Sodium after root canal treatment to reduce post-operative pain.

1 treatment period with pain assessments at 1, 6, 12, and 24 hours

Trial Site Locations

Total: 1 location

1

Dow University of Health Sciences

Karachi, Sindh, Pakistan, 74200

Actively Recruiting

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Research Team

D

Dr. Hafsa Zaki, BDS

D

Dr. Shahbaz Ahmed, BDS

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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Published Research Related To This Trial

The Effect of Trypsin-Chymotrypsin on Postoperative Pain after Single Visit Endodontic Treatment: A Randomized Controlled Trial.

Ahmed Abdel Rahman Hashem, Alaa Adly Abd El Sattar, Tariq Yehia Abdel Rahman

https://pubmed.ncbi.nlm.nih.gov/36574828

Longer analgesic effect with naproxen sodium than ibuprofen in post-surgical dental pain: a randomized, double-blind, placebo-controlled, single-dose trial.

Stephen A Cooper, Paul Desjardins, Patrick Brain...

https://pubmed.ncbi.nlm.nih.gov/31402718

Antibiotics for the urgent management of symptomatic irreversible pulpitis, symptomatic apical periodontitis, and localized acute apical abscess: Systematic review and meta-analysis-a report of the American Dental Association.

Malavika P Tampi, Lauren Pilcher, Olivia Urquhart...

https://pubmed.ncbi.nlm.nih.gov/31761029

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