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

NCT ID: NCT06562816

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-16
• Study Completion Date: 2025-01-31

Brief Summary

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.

Detailed Description

i. Background Prevention or management of pain, especially after root canal treatment, is of utmost importance to Endodontists. Non-steroidal anti-inflammatory drugs (NSAIDs) have been the most commonly used pain reduction modality in cases of irreversible pulpitis, but they do come with certain demerits. A lot of other alternatives have been researched as better alternatives for NSAIDs. Trypsin- Chymotrypsin has been proven to be an effective pain reducer after endodontic therapy.

ii. Objective The objective of this study is to compare the pain reduction efficacy of Trypsin- Chymotrypsin and Naproxen sodium after root canal treatment.

iii. Methodology In this triple-blinded, parallel, randomized controlled trial, a total of 100 patients will be included who are coming to the Operative Dentistry department for root canal treatment for any tooth. The patient must have a history of symptomatic irreversible pulpitis. The patients will be randomly allocated into two groups. One group (n = 50 will be the Trypsin- Chymotrypsin group, and the second group (n = 50) will be the Naproxen sodium group (active control group). The root canal treatment will be performed as usual. The first group will receive Trypsin- Chymotrypsin 1:100000 and the second group will receive Naproxen Sodium 550mg in sealed envelopes. The intensity of post-operative pain will be evaluated using a numerical rating scale at 1 hour, 6 hours, 12 hours, and 24 hour intervals.

iv. Sequence Generation: Computer generated randomization using appropriate software (random.org) to assign the participants to trypsin-chymotrypsin or naproxen sodium group, ensuring a complete random allocation to each treatment arm, decreasing a risk of bias and enhancing the internal validity of the study.

v. Blinding: The participants, researcher and outcome assessors will be blinded in this research (triple blinded).

vi. Allocation Concealment: The allocation concealment will be achieved by packaging medicines in tightly sealed, opaque envelopes by a different person not conducting research or assessing outcomes. This process ensured that researchers involved in participant enrollment could not predict or influence the treatment assignment, reducing the risk of selection bias.

Conditions

Effect of Drug

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Trypsin-Chymotrypsin

This group will receive sealed envelopes containing oral formulations of Trypsin:Chymotryspin in the ratio of 6:1 with an enzymatic activity of 100000 A.U./tablet (Tab. Chymoral Forte) three times a day, 30 minutes before meals for 24 hours.

Group Type: EXPERIMENTAL

Trypsin-Chymotrypsin

Intervention Type: DRUG

100000 IU

Naproxen Sodium

The active control group will receive oral formulation of Naproxen Sodium 550mg (Tab. Synflex) twice a day, after meals for 24 hours.

Group Type: ACTIVE_COMPARATOR

Naproxen Sodium 550mg

Intervention Type: DRUG

550mg

Interventions

Trypsin-Chymotrypsin

100000 IU

Intervention Type: DRUG

Naproxen Sodium 550mg

550mg

Intervention Type: DRUG

Other Intervention Names

Chymoral Forte; Synflex 550mg

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dow University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Hafsa Zaki

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Hafsa Zaki

Role: PRINCIPAL_INVESTIGATOR

DUHS

Locations

Dow University of Health Sciences

Karachi, Sindh, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Dr. Hafsa Zaki, BDS

Role: CONTACT

hafsazaki99@hotmail.com

+923462746052

Dr. Shahbaz Ahmed, BDS

Role: CONTACT

saj119@googlemail.com

+923212000873

Facility Contacts

Dr. Hafsa Zaki

Role: primary

hafsazaki99@hotmail.com

+923462746052

Dr. Shahbaz Ahmed

Role: backup

saj119@googlemail.com

+923212000873

References

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Reference Type: BACKGROUND

PMID: 21902704 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 36574828 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 25821010 (View on PubMed)

Other Identifiers

3376

Identifier Type: -

Identifier Source: org_study_id