Efficacy of Trypsin-Chymotrypsin On Post-operative Pain After Single Visit Root Canal Treatment

NCT05479747 | Completed Phase 4 Results

• 1 other identifier: FDASU-Rec IM012110
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Achieving effective pain control after endodontic treatment is still a disruptive event to all the clinicians. There is a knowledge gap regarding the effect of protease on postoperative pain following root canal treatment, therefore, the efficacy of Trypsin-Chymotrypsin on post endodontic pain was evaluated clinically in a randomized triple-blind trial.

Conditions

Effect of Drug

Keywords

Trypsin and chymotrypsin; Ibuprofen; postoperative pain; Analgesic drugs; pain control drugs

Outcome Measures

Primary Outcomes (1)

• Effect of Trypsin-Chymotrypsin on Post-operative Pain After Single Endodontic Treatment in Teeth With Symptomatic Irreversible Pulpitis

  analgesic effect assessed by numerical rating scale. The minimum score value is zero. The maximum score value is ten. Maximum scores indicate the worst possible outcome.

  from 6 hours following drug intake after obturation to 72 hours (start with 6 hours first interval then at 12 hours intervals)

Secondary Outcomes (2)

• Synergistic Effect With NSAIDS

  from 6 hours following drug intake after obturation to 72 hours (start with 6 hours first interval then at 12 hours intervals)

• Reported Side Effect

  from 6 hours following drug intake after obturation to 72 hours (start with 6 hours first interval then at 12 hours intervals)

Study Arms (4)

Ibuprofen (Brufen)

ACTIVE COMPARATOR

Participants were handed Brufen (Ibuprofen) (Abbott chemical laboratories, Advil, USA) 600 mg 3 times daily for 3 days after meals in tightly sealed envelope with an included written paper contained the instruction for dose administration.

Drug: post operative analgesics

Trypsin 5 mg Chymotrypsin 5 mg (Ambezim G)

EXPERIMENTAL

Participants were handed Ambezim G (Trypsin 5 mg Chymotrypsin 5 mg) (Global Napi Pharmaceutical Company, Giza, Egypt) 3 times daily for 3 days one hour before meals in tightly sealed envelope with an included written paper contained the instruction for dose administration.

Drug: post operative analgesics

Ibuprofen (Brufen) + Trypsin 5 mg Chymotrypsin 5 mg (Ambezim G)

ACTIVE COMPARATOR

Participants were handed Brufen (Ibuprofen) (Abbott chemical laboratories, Advil, USA) 600 mg 3 times daily for 3 days after meals and Ambezim G (Trypsin 5 mg Chymotrypsin 5 mg) (Global Napi Pharmaceutical Company, Giza, Egypt) 3 times daily for 3 days one hour before meals in tightly sealed envelope with an included written paper contained the instruction for dose administration.

Drug: post operative analgesics

Placebo pills (Sugar pills)

PLACEBO COMPARATOR

Participants were handed postoperatively sugar pills (Placebo pills) (Department of pharmaceutics \& industrial pharmacy at Faculty of pharmacy Ain Shams University, Cairo, Egypt) 3 times daily for 3 days in tightly sealed envelope with an included written paper contained the instruction for dose administration.

Drug: post operative analgesics

Interventions

post operative analgesics DRUG

post-operative pain killer

Also known as: pain control drug

Ibuprofen (Brufen); Ibuprofen (Brufen) + Trypsin 5 mg Chymotrypsin 5 mg (Ambezim G); Placebo pills (Sugar pills); Trypsin 5 mg Chymotrypsin 5 mg (Ambezim G)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Egyptian healthy symptomatic both gender patients
• aged (18- 40) years old
• with no physical disability, facial paresthesia or psychological problems
• had mandibular first molars with symptomatic irreversible pulpitis and with normal appearance radiographically.

You may not qualify if:

• The vulnerable group
• participants who un abled to read and fill the questionnaire,
• those who took preoperative analgesics 24 h prior to treatment
• those with known sensitivity to the drugs used in this study

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ahmed Abdel Rahman Hashem

Cairo, Egypt

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Dr
• Organization: Faculty of Dentistry, Ain Shams University

AlaaMahmoud@dent.asu.edu.eg

+11112228724

Study Officials

• Ahmed A Hashem, PHD

  Head of endodontic department Faculty of dentistry Ain Shams University, cairo,Egypt

  STUDY CHAIR

• Tariq Y Abdel Rahman, PHD

  Lecturer, Endodontic Department, Faculty of Dentistry, Ain Shams University

  STUDY DIRECTOR

• Alaa A Abd El Sattar, Master

  Faculty of Dentistry, Ain Shams University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: 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: July 25, 2022
• First Posted: July 29, 2022
• Study Start: June 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 1, 2024
• Results First Posted: March 1, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)