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

NCT06562816 | Recruiting Phase 4

• 1 other identifier: 3376
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Effect of Drug

Keywords

Trypsin-Chymotrypsin; Naproxen Sodium; Symptomatic Irreversible Pulpitis; Acute Irreversible Pulpitis; Post-endodontic treatment pain; Root canal treatment; Proteolytic Enzyme

Outcome Measures

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.

  24 hours

Study Arms (2)

Trypsin-Chymotrypsin

EXPERIMENTAL

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.

Drug: Trypsin-Chymotrypsin

Naproxen Sodium

ACTIVE COMPARATOR

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

Drug: Naproxen Sodium 550mg

Interventions

Trypsin-Chymotrypsin DRUG

100000 IU

Also known as: Chymoral Forte

Trypsin-Chymotrypsin

Naproxen Sodium 550mg DRUG

550mg

Also known as: Synflex 550mg

Naproxen Sodium

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, 74200, Pakistan

RECRUITING

Related Publications (6)

• Mehrvarzfar P, Abbott PV, Saghiri MA, Delvarani A, Asgar K, Lotfi M, Karamifar K, Kharazifard MJ, Khabazi H. Effects of three oral analgesics on postoperative pain following root canal preparation: a controlled clinical trial. Int Endod J. 2012 Jan;45(1):76-82. doi: 10.1111/j.1365-2591.2011.01950.x. Epub 2011 Sep 8.

  PMID: 21902704 BACKGROUND

• Hashem AAR, Abd El Sattar AA, Abdel Rahman TY. The Effect of Trypsin-Chymotrypsin on Postoperative Pain after Single Visit Endodontic Treatment: A Randomized Controlled Trial. J Endod. 2023 Mar;49(3):240-247. doi: 10.1016/j.joen.2022.12.010. Epub 2022 Dec 24.

  PMID: 36574828 BACKGROUND

• Cooper SA, Desjardins P, Brain P, Paredes-Diaz A, Troullos E, Centofanti R, An B. Longer analgesic effect with naproxen sodium than ibuprofen in post-surgical dental pain: a randomized, double-blind, placebo-controlled, single-dose trial. Curr Med Res Opin. 2019 Dec;35(12):2149-2158. doi: 10.1080/03007995.2019.1655257. Epub 2019 Aug 27.

  PMID: 31402718 BACKGROUND

• Tampi MP, Pilcher L, Urquhart O, Kennedy E, O'Brien KK, Lockhart PB, Abt E, Aminoshariae A, Durkin MJ, Fouad AF, Gopal P, Hatten BW, Lang MS, Patton LL, Paumier T, Suda KJ, Cho H, Carrasco-Labra A. 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. J Am Dent Assoc. 2019 Dec;150(12):e179-e216. doi: 10.1016/j.adaj.2019.09.011.

  PMID: 31761029 BACKGROUND

• Al-Hadidi F, Bsisu I, AlRyalat SA, Al-Zu'bi B, Bsisu R, Hamdan M, Kanaan T, Yasin M, Samarah O. Association between mobile phone use and neck pain in university students: A cross-sectional study using numeric rating scale for evaluation of neck pain. PLoS One. 2019 May 20;14(5):e0217231. doi: 10.1371/journal.pone.0217231. eCollection 2019.

  PMID: 31107910 BACKGROUND

• Mkontwana N, Novikova N. Oral analgesia for relieving post-caesarean pain. Cochrane Database Syst Rev. 2015 Mar 29;2015(3):CD010450. doi: 10.1002/14651858.CD010450.pub2.

  PMID: 25821010 BACKGROUND

MeSH Terms

Interventions

chymotrypsin, trypsin drug combination; Naproxen

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Dr. Hafsa Zaki

  DUHS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Hafsa Zaki, BDS

CONTACT

+923462746052; hafsazaki99@hotmail.com

Dr. Shahbaz Ahmed, BDS

CONTACT

+923212000873; saj119@googlemail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 20, 2024
• Study Start: August 16, 2024
• Primary Completion: November 30, 2024
• Study Completion: January 31, 2025
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)