Efficacy of Trypsin-Chymotrypsin On Post-operative Pain After Single Visit Root Canal Treatment
Condition: Effect of Drug
Study type: Interventional
Phase: Phase 4

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).

      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.
    

Intervention name(s): post operative analgesics
Intervention type(s): Drug
Intervention description(s): post-operative pain killer
Other intervention name(s): pain control drug
Intervention MeSH terms: Analgesics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Trypsin and chymotrypsin; Ibuprofen; postoperative pain; Analgesic drugs; pain control drugs