Effect of DrugPhase 4NCT05479747
Efficacy of Trypsin-Chymotrypsin On Post-operative Pain After Single Visit Root Canal Treatment
A Phase 4 study testing post operative analgesics in people with Effect of Drug, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Effect of Drug
- What is being tested?
- post operative analgesics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 31 Dec 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Trypsin-Chymotrypsin On Postoperative Pain After Single Visit Endodontic Treatment A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Effect of Drug
- Being tested
- post operative analgesics
- Keywords
- Trypsin and chymotrypsin, Ibuprofen, postoperative pain, Analgesic drugs, pain control drugs
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
post operative analgesicsDrug
Also called pain control drug
post-operative pain killer
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: post operative analgesics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
assessed by Passive surveillance of harm. It depends on adverse effects reported by the participants.
Measured: from 6 hours following drug intake after obturation to 72 hours (start with 6 hours first interval then at 12 hours intervals)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start1 Jun 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effect of DrugStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Adly Abd El-Sattar Mahmoud, Ain Shams University
- Investigators
- Ahmed A Hashem, PHD, Study chair, Head of endodontic department Faculty of dentistry Ain Shams University, cairo,EgyptTariq Y Abdel Rahman, PHD, Study director, Lecturer, Endodontic Department, Faculty of Dentistry, Ain Shams UniversityAlaa A Abd El Sattar, Master, Principal investigator, Faculty of Dentistry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479747
- Sponsor's protocol ID
- FDASU-Rec IM012110
- Status last verified
- Jul 2023
- First submitted
- 25 Jul 2022
- Last updated
- 1 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36574828
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Trypsin-Chymotrypsin On Postoperative Pain After Single Visit Endodontic Treatment A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05479747
- Acronym / sponsor ID
- FDASU-Rec IM012110
- Conditions
- Effect of Drug
- Keywords
- Trypsin and chymotrypsin, Ibuprofen, postoperative pain, Analgesic drugs, pain control drugs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 29 Jul 2022 (actual)
- Results
- Posted 1 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen (Brufen) | Active comparator | Drug: post operative analgesicsParticipants 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. |
| Trypsin 5 mg Chymotrypsin 5 mg (Ambezim G) | Experimental | Drug: post operative analgesicsParticipants 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. |
| Ibuprofen (Brufen) + Trypsin 5 mg Chymotrypsin 5 mg (Ambezim G) | Active comparator | Drug: post operative analgesicsParticipants 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. |
| Placebo pills (Sugar pills) | Placebo comparator | Drug: post operative analgesicsParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| post operative analgesicsAlso: pain control drugpost-operative pain killer | 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) |
Primary outcome
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.
2 secondary outcomes
Synergistic Effect With NSAIDS
Time frame: 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
Time frame: from 6 hours following drug intake after obturation to 72 hours (start with 6 hours first interval then at 12 hours intervals)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36574828Hashem 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed A Hashem, PHD study chair
Head of endodontic department Faculty of dentistry Ain Shams University, cairo,Egypt
Tariq Y Abdel Rahman, PHD study director
Lecturer, Endodontic Department, Faculty of Dentistry, Ain Shams University
Alaa A Abd El Sattar, Master principal investigator
Faculty of Dentistry, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing post operative analgesics in people with Effect of Drug, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05479747, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.