Trial Outcomes & Findings for Efficacy of Trypsin-Chymotrypsin On Post-operative Pain After Single Visit Root Canal Treatment (NCT NCT05479747)
NCT ID: NCT05479747
Last Updated: 2024-03-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
from 6 hours following drug intake after obturation to 72 hours (start with 6 hours first interval then at 12 hours intervals)
Results posted on
2024-03-01
Participant Flow
Participant milestones
| Measure |
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.
post operative analgesics: post-operative pain killer
|
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.
post operative analgesics: post-operative pain killer
|
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.
post operative analgesics: post-operative pain killer
|
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.
post operative analgesics: post-operative pain killer
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Trypsin-Chymotrypsin On Post-operative Pain After Single Visit Root Canal Treatment
Baseline characteristics by cohort
| Measure |
Ibuprofen (Brufen)
n=15 Participants
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.
post operative analgesics: post-operative pain killer
|
Trypsin 5 mg Chymotrypsin 5 mg (Ambezim G)
n=15 Participants
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.
post operative analgesics: post-operative pain killer
|
Ibuprofen (Brufen) + Trypsin 5 mg Chymotrypsin 5 mg (Ambezim G)
n=15 Participants
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.
post operative analgesics: post-operative pain killer
|
Placebo Pills (Sugar Pills)
n=15 Participants
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.
post operative analgesics: post-operative pain killer
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
27.5 years
STANDARD_DEVIATION 8 • n=5 Participants
|
27.8 years
STANDARD_DEVIATION 8 • n=7 Participants
|
27.9 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
28 years
STANDARD_DEVIATION 7.7 • n=4 Participants
|
27.8 years
STANDARD_DEVIATION 7.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Egyptian
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
15 participants
n=4 Participants
|
60 participants
n=21 Participants
|
|
Region of Enrollment
Egypt
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
15 participants
n=4 Participants
|
60 participants
n=21 Participants
|
|
pre-operative pain scores
|
8.4 units on a scale
STANDARD_DEVIATION 0.63 • n=5 Participants
|
8.53 units on a scale
STANDARD_DEVIATION 1.13 • n=7 Participants
|
8.13 units on a scale
STANDARD_DEVIATION 1.36 • n=5 Participants
|
8.73 units on a scale
STANDARD_DEVIATION 0.8 • n=4 Participants
|
8.4 units on a scale
STANDARD_DEVIATION 0.98 • n=21 Participants
|
PRIMARY outcome
Timeframe: from 6 hours following drug intake after obturation to 72 hours (start with 6 hours first interval then at 12 hours intervals)Population: We detect the effect of Trypsin 5 mg Chymotrypsin 5 mg (Ambezim G) on post-operative pain and compared its effect with the most known potent analgesic ibuprofen (Brufen) and with a combination of both drugs and with Placebo pills (Sugar pills) for better evaluation of its efficacy.
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.
Outcome measures
| Measure |
Ibuprofen (Brufen)
n=15 Participants
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.
post operative analgesics: post-operative pain killer
|
Trypsin 5 mg Chymotrypsin 5 mg (Ambezim G)
n=15 Participants
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.
post operative analgesics: post-operative pain killer
|
Ibuprofen (Brufen) + Trypsin 5 mg Chymotrypsin 5 mg (Ambezim G)
n=15 Participants
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.
post operative analgesics: post-operative pain killer
|
Placebo Pills (Sugar Pills)
n=15 Participants
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.
post operative analgesics: post-operative pain killer
|
|---|---|---|---|---|
|
Effect of Trypsin-Chymotrypsin on Post-operative Pain After Single Endodontic Treatment in Teeth With Symptomatic Irreversible Pulpitis
after 6 hours follow up
|
3.47 score on a scale
Standard Deviation 1.55
|
3.53 score on a scale
Standard Deviation 1.46
|
2.93 score on a scale
Standard Deviation 1.33
|
6.13 score on a scale
Standard Deviation 0.64
|
|
Effect of Trypsin-Chymotrypsin on Post-operative Pain After Single Endodontic Treatment in Teeth With Symptomatic Irreversible Pulpitis
after 12 hours follow up
|
2 score on a scale
Standard Deviation 1.41
|
1.87 score on a scale
Standard Deviation 1.51
|
1.4 score on a scale
Standard Deviation 0.91
|
4.47 score on a scale
Standard Deviation 0.64
|
|
Effect of Trypsin-Chymotrypsin on Post-operative Pain After Single Endodontic Treatment in Teeth With Symptomatic Irreversible Pulpitis
after 24 hours follow up
|
0.87 score on a scale
Standard Deviation 1.06
|
0.8 score on a scale
Standard Deviation 1.08
|
0.2 score on a scale
Standard Deviation 0.41
|
3.4 score on a scale
Standard Deviation 0.74
|
|
Effect of Trypsin-Chymotrypsin on Post-operative Pain After Single Endodontic Treatment in Teeth With Symptomatic Irreversible Pulpitis
after 48 hours follow up
|
0 score on a scale
Standard Deviation 0
|
0.13 score on a scale
Standard Deviation 0.52
|
0 score on a scale
Standard Deviation 0
|
2.47 score on a scale
Standard Deviation 0.64
|
|
Effect of Trypsin-Chymotrypsin on Post-operative Pain After Single Endodontic Treatment in Teeth With Symptomatic Irreversible Pulpitis
after 72 hours follow up
|
0 score on a scale
Standard Deviation 0
|
0.13 score on a scale
Standard Deviation 0.52
|
0 score on a scale
Standard Deviation 0
|
1.2 score on a scale
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: from 6 hours following drug intake after obturation to 72 hours (start with 6 hours first interval then at 12 hours intervals)Population: We compared the result of each pharmaceutical alone with the result of a combination of both drugs in group Ibuprofen (Brufen) + Trypsin 5 mg Chymotrypsin 5 mg (Ambezim G) to conclude the secondary outcome (synergistic effect with NSAIDS).
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.
Outcome measures
| Measure |
Ibuprofen (Brufen)
n=15 Participants
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.
post operative analgesics: post-operative pain killer
|
Trypsin 5 mg Chymotrypsin 5 mg (Ambezim G)
n=15 Participants
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.
post operative analgesics: post-operative pain killer
|
Ibuprofen (Brufen) + Trypsin 5 mg Chymotrypsin 5 mg (Ambezim G)
n=15 Participants
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.
post operative analgesics: post-operative pain killer
|
Placebo Pills (Sugar Pills)
n=15 Participants
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.
post operative analgesics: post-operative pain killer
|
|---|---|---|---|---|
|
Synergistic Effect With NSAIDS
after 6 hours follow up
|
3.47 score on a scale
Standard Deviation 1.55
|
3.53 score on a scale
Standard Deviation 1.46
|
2.93 score on a scale
Standard Deviation 1.33
|
6.13 score on a scale
Standard Deviation 0.64
|
|
Synergistic Effect With NSAIDS
after 12 hours follow up
|
2 score on a scale
Standard Deviation 1.41
|
1.87 score on a scale
Standard Deviation 1.51
|
1.4 score on a scale
Standard Deviation 0.91
|
4.47 score on a scale
Standard Deviation 0.64
|
|
Synergistic Effect With NSAIDS
after 24 hours follow up
|
0.87 score on a scale
Standard Deviation 1.06
|
0.8 score on a scale
Standard Deviation 1.08
|
0.2 score on a scale
Standard Deviation 0.41
|
3.4 score on a scale
Standard Deviation 0.74
|
|
Synergistic Effect With NSAIDS
after 48 hours follow up
|
0 score on a scale
Standard Deviation 0
|
0.13 score on a scale
Standard Deviation 0.52
|
0 score on a scale
Standard Deviation 0
|
2.47 score on a scale
Standard Deviation 0.64
|
|
Synergistic Effect With NSAIDS
after 72 hours follow up
|
0 score on a scale
Standard Deviation 0
|
0.13 score on a scale
Standard Deviation 0.52
|
0 score on a scale
Standard Deviation 0
|
1.2 score on a scale
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Ibuprofen (Brufen)
n=15 Participants
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.
post operative analgesics: post-operative pain killer
|
Trypsin 5 mg Chymotrypsin 5 mg (Ambezim G)
n=15 Participants
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.
post operative analgesics: post-operative pain killer
|
Ibuprofen (Brufen) + Trypsin 5 mg Chymotrypsin 5 mg (Ambezim G)
n=15 Participants
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.
post operative analgesics: post-operative pain killer
|
Placebo Pills (Sugar Pills)
n=15 Participants
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.
post operative analgesics: post-operative pain killer
|
|---|---|---|---|---|
|
Reported Side Effect
after 72 hours
|
0 reported side effects
Standard Deviation 0
|
0 reported side effects
Standard Deviation 0
|
0 reported side effects
Standard Deviation 0
|
0 reported side effects
Standard Deviation 0
|
|
Reported Side Effect
after 6 hours
|
0 reported side effects
Standard Deviation 0
|
0 reported side effects
Standard Deviation 0
|
0 reported side effects
Standard Deviation 0
|
0 reported side effects
Standard Deviation 0
|
|
Reported Side Effect
after 12 hours
|
0 reported side effects
Standard Deviation 0
|
0 reported side effects
Standard Deviation 0
|
0 reported side effects
Standard Deviation 0
|
0 reported side effects
Standard Deviation 0
|
|
Reported Side Effect
after 24 hours
|
0 reported side effects
Standard Deviation 0
|
0 reported side effects
Standard Deviation 0
|
0 reported side effects
Standard Deviation 0
|
0 reported side effects
Standard Deviation 0
|
|
Reported Side Effect
after 48 hours
|
0 reported side effects
Standard Deviation 0
|
0 reported side effects
Standard Deviation 0
|
0 reported side effects
Standard Deviation 0
|
0 reported side effects
Standard Deviation 0
|
Adverse Events
Ibuprofen (Brufen)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Trypsin 5 mg Chymotrypsin 5 mg (Ambezim G)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ibuprofen (Brufen) + Trypsin 5 mg Chymotrypsin 5 mg (Ambezim G)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Pills (Sugar Pills)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place