The Effect of Trypsin-Chymotrypsin On Postoperative Pain After Single Visit Endodontic Treatment A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Effect of Trypsin-Chymotrypsin on Post-operative Pain After Single Endodontic Treatment in Teeth With Symptomatic Irreversible Pulpitis
Study Overview
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.
Detailed Description
This study approved by the institutional review of board (IRB) of the ethics committee at the Faculty of Dentistry, Ain Shams University, Cairo, Egypt under approval number FDASU-Rec IM012110.
This study design was a prospective, parallel triple blind phase IV randomized clinical trial.
A pilot study was performed on five patients in each group and its results were used for sample size calculation. Based upon the results of the pilot study; the minimum estimated sample size was a total of 52 patients. Sample size was increased to 60 for compensation of the drop-out. Sample size calculation was performed by using G*Power Version 3.1.9.2.
All included patient signed an informed consent prior to start of the study.
Randomization and blinding:60 patients who had the eligibility criteria were allocated randomly according to the ratio of 1:1 to each group. Randomization was performed by using computer software (www.randome.org).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Ibuprofen (Brufen)
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.
Intervention: post operative analgesics (Drug)
Trypsin 5 mg Chymotrypsin 5 mg (Ambezim G)
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.
Intervention: post operative analgesics (Drug)
Ibuprofen (Brufen) + Trypsin 5 mg Chymotrypsin 5 mg (Ambezim G)
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.
Intervention: post operative analgesics (Drug)
Placebo pills (Sugar pills)
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.
Intervention: post operative analgesics (Drug)
Outcomes
Primary Outcomes
Effect of Trypsin-Chymotrypsin on Post-operative Pain After Single Endodontic Treatment in Teeth With Symptomatic Irreversible Pulpitis
Time Frame: from 6 hours following drug intake after obturation to 72 hours (start with 6 hours first interval then at 12 hours intervals)
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.
Secondary Outcomes
- 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))
- 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))
Investigators
Alaa Adly Abd El-Sattar Mahmoud
principal investigator
Ain Shams University