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

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT05479747

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Effect of Drug	Drug: post operative analgesics	Phase 4

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).

Allocation concealment mechanism: Random sequence generations, allocation concealment and interventions preparation were occurred before starting by the help of one independent person who concealed the allocation sequence from the investigators in opaque and tightly sealed envelope. Before study implementation, this person also divided the medicaments into 60 tightly sealed opaque envelopes contained a treatment with the recommended dose and labeled by one-digit alphabetical symbol (X, Y, Z, R).

Implementation of the study: After root canal treatment, post-operative medicaments were assigned by telephone verification. This independent person informed the operator which drug should be prescribed in the form of X, Y, Z or R to maintain operator blinding. The investigators used the computerized generated randomization protocol for each eligible patient. So, patients were enrolled into each of the groups and prescribed with different post-operative intervention. All pain assessment forms and data were monitored by a trained clinician. He was not a part of the study team.The statistician was also blinded.

Patient history revealed diffuse lingering pulpal pain. Cold sensibility testing with Endo-Ice (1,1,1,2 Tetrafluoroethane; Hygenic Corp) indicated a moderate to severe response. Vitality was matched with the contra lateral as control. The vitality was established clinically by blood observation in the canal. Teeth had no sensitivity to percussion or palpation. Radiographically had normal periapical condition. Endodontic treatment procedures were done by the same operator in the post-graduate clinic of the Endodontic Department of the Faculty of Dentistry, Ain Shams University, Egypt. Patients were assessed by a trained clinician who was not a part of the study team.

85 patients were assessed for the eligibility criteria. 25 individuals were excluded due to different reasons. 60 participants were included. They were randomized into four groups (N = 15).

Group I: (ibuprofen) Participants were given ibuprofen 600 mg 3 times per day for 3 days after each of the three meals.

Group II: (Trypsin-Chymotrypsin) Participants were given (Trypsin 5 mg Chymotrypsin 5 mg3 times per day for 3 days one hour before each of the three meals.

Group III: (ibuprofen + Trypsin Chymotrypsin) Participants were given ibuprofen 600 mg 3 times per day for 3 days after each of the three meals and (Trypsin 5 mg Chymotrypsin 5 mg) 3 times per day for 3 days one hour before each of the three meals.

Group IV: (placebo) Participants were given postoperatively placebo sugar pills 3 times per day for 3 day.

All participant were asked to record their postoperative pain intensity at 6h ,12h ,24h, 48h ,72h following obturation. They also asked to report the occurrence of any side effects.

Data analysis:

Statistical analysis was undertaken with IBM SPSS Statistics. Age difference was analyzed by using one-way ANOVA test. For Pain records, Kruskal-Wallis test for comparison among the four groups, Friedman's test for changes by time intervals in each group and for pair-wise comparisons when Kruskal-Wallis or Friedman's test was significant, Dunn's test was used. Chi-square test was used for qualitative data. The significance level was set at P ≤ 0.05.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effect of Trypsin-Chymotrypsin On Postoperative Pain After Single Visit Endodontic Treatment A Randomized Controlled Trial

Actual Study Start Date :

Jun 1, 2021

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: post operative analgesics post-operative pain killer Other Names: pain control drug
Experimental: 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.	Drug: post operative analgesics post-operative pain killer Other Names: pain control drug
Active Comparator: 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.	Drug: post operative analgesics post-operative pain killer Other Names: pain control drug
Placebo Comparator: 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.	Drug: post operative analgesics post-operative pain killer Other Names: pain control drug

Outcome Measures

Primary Outcome Measures

effect of Trypsin-Chymotrypsin on post-operative pain after single endodontic treatment in teeth with symptomatic irreversible pulpitis [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 Outcome Measures

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)]
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.
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)]
assessed by Passive surveillance of harm. It depends on adverse effects reported by the participants.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

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.

Exclusion criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Abdel Rahman Hashem	Cairo		Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

Study Chair: Ahmed A Hashem, PHD, Head of endodontic department Faculty of dentistry Ain Shams University, cairo,Egypt
Study Director: Tariq Y Abdel Rahman, PHD, Lecturer, Endodontic Department, Faculty of Dentistry, Ain Shams University
Principal Investigator: Alaa A Abd El Sattar, Master, Faculty of Dentistry, Ain Shams University