Effect of DrugPhase 4NCT06562816
Comparing Trypsin-Chymotrypsin and Naproxen Sodium for Post-endodontic Treatment Pain
A Phase 4 study testing Trypsin-Chymotrypsin and Naproxen Sodium 550mg in people with Effect of Drug, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
This study aims to compare the pain reduction efficacy of Trypsin-Chymotrypsin and Naproxen sodium after root canal treatment in patients with symptomatic irreversible pulpitis. A lot of patients suffer greatly from post endodontic treatment pain and have a fear of dental treatments due to the pain. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Drug
- What is being tested?
- Trypsin-Chymotrypsin and Naproxen Sodium 550mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Aug 2024to 31 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both male and female, healthy patients (ASA class 1).
- Patients between the age group of 18-45 years.
- Patients who are appointed for endodontic treatment.
- Maxillary or mandibular teeth diagnosed with symptomatic irreversible pulpitis based on delayed responses to vitality tests.
Who cannot join
- Patients who will require emergency dental treatment.
- Teeth with any form of peri-apical lesion will be excluded.
- Patient who have taken analgesics within 24 hours prior to the treatment.
- Patients with known hypersensitivity or allergy to any of the study medications.
- Patients with any systemic disease such as uncontrolled diabetes, gastric ulcers, bleeding disorders, or cardiovascular problems.
- Pregnant or lactating women and pediatric patients.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Dow University of Health Sciences
Karachi, Sindh, 74200
Dr. Hafsa Zaki, +923462746052, hafsazaki99@hotmail.com
Dr. Shahbaz Ahmed, +923212000873, saj119@googlemail.com
About this study
Official title: Comparing Trypsin-Chymotrypsin and Naproxen Sodium for Post-endodontic Treatment Pain: a Randomized Controlled Trial
This study aims to compare the pain reduction efficacy of Trypsin-Chymotrypsin and Naproxen sodium after root canal treatment in patients with symptomatic irreversible pulpitis. A lot of patients suffer greatly from post endodontic treatment pain and have a fear of dental treatments due to the pain. Patients refuse to go to the dentists and neglect oral hygiene care. That's why it is very important to find an effective drug regimen to reduce this post treatment pain. The null hypothesis is that there will be no difference between the efficacy and mean pain scores of Trypsin-chymotrypsin and Naproxen Sodium for post-endodontic treatment pain. Conducted as a triple-blinded, parallel, randomized controlled trial, 100 patients will be randomly assigned to receive either Trypsin-Chymotrypsin or Naproxen sodium following standard root canal therapy. Pain levels will be assessed using a numerical rating scale at 1, 6, 12, and 24 hours post-treatment to evaluate the effectiveness of these two pain management modalities.
Read the detailed description
- Background Prevention or management of pain, especially after root canal treatment, is of utmost importance to Endodontists. Non-steroidal anti-inflammatory drugs (NSAIDs) have been the most commonly used pain reduction modality in cases of irreversible pulpitis, but they do come with certain demerits. A lot of other alternatives have been researched as better alternatives for NSAIDs. Trypsin- Chymotrypsin has been proven to be an effective pain reducer after endodontic therapy. ii. Objective The objective of this study is to compare the pain reduction efficacy of Trypsin- Chymotrypsin and Naproxen sodium after root canal treatment. iii. Methodology In this triple-blinded, parallel, randomized controlled trial, a total of 100 patients will be included who are coming to the Operative Dentistry department for root canal treatment for any tooth. The patient must have a history of symptomatic irreversible pulpitis. The patients will be randomly allocated into two groups. One group (n = 50 will be the Trypsin- Chymotrypsin group, and the second group (n = 50) will be the Naproxen sodium group (active control group). The root canal treatment will be performed as usual. The first group will receive Trypsin- Chymotrypsin 1:100000 and the second group will receive Naproxen Sodium 550mg in sealed envelopes. The intensity of post-operative pain will be evaluated using a numerical rating scale at 1 hour, 6 hours, 12 hours, and 24 hour intervals. iv. Sequence Generation: Computer generated randomization using appropriate software (random.org) to assign the participants to trypsin-chymotrypsin or naproxen sodium group, ensuring a complete random allocation to each treatment arm, decreasing a risk of bias and enhancing the internal validity of the study.
- Blinding: The participants, researcher and outcome assessors will be blinded in this research (triple blinded). vi. Allocation Concealment: The allocation concealment will be achieved by packaging medicines in tightly sealed, opaque envelopes by a different person not conducting research or assessing outcomes. This process ensured that researchers involved in participant enrollment could not predict or influence the treatment assignment, reducing the risk of selection bias.
- Conditions
- Effect of Drug
- Being tested
- Trypsin-Chymotrypsin, Naproxen Sodium 550mg
- Keywords
- Trypsin-Chymotrypsin, Naproxen Sodium, Symptomatic Irreversible Pulpitis, Acute Irreversible Pulpitis, Post-endodontic treatment pain, Root canal treatment, Proteolytic Enzyme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trypsin-ChymotrypsinDrug
Also called Chymoral Forte
100000 IU
Naproxen Sodium 550mgDrug
Also called Synflex 550mg
550mg
| Study group | Role | What they receive |
|---|---|---|
| Trypsin-Chymotrypsin | Experimental | This group will receive sealed envelopes containing oral formulations of Trypsin:Chymotryspin in the ratio of 6:1 with an enzymatic activity of 100000 A.U./tablet (Tab. Chymoral Forte) three times a day, 30 minutes before meals for 24 hours. Receives: Drug: Trypsin-Chymotrypsin |
| Naproxen Sodium | Active comparator | The active control group will receive oral formulation of Naproxen Sodium 550mg (Tab. Synflex) twice a day, after meals for 24 hours. Receives: Drug: Naproxen Sodium 550mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in post-endodontic treatment pain score using Numeric Rating Scale
The Numeric Rating Scale (NRS-11) is an eleven-point scale that ranges from 0, indicating no pain, to 10, representing the most severe pain the patient has ever encountered.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start16 Aug 2024
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Effect of DrugStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hafsa Zaki, Dow University of Health Sciences
- Investigators
- Dr. Hafsa Zaki, Principal investigator, DUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562816
- Sponsor's protocol ID
- 3376
- Status last verified
- Oct 2024
- First submitted
- 16 Aug 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is some information that can be sensitive to some patients. Sharing this data can compromise their confidentiality and cause a breach of their privacy. Anonymous data can be shared upon request.
Publications
Mehrvarzfar P, Abbott PV, Saghiri MA, Delvarani A, Asgar K, Lotfi M, Karamifar K, Kharazifard MJ, Khabazi H. Effects of three oral analgesics on postoperative pain following root canal preparation: a controlled clinical trial. Int Endod J. 2012 Jan;45(1):76-82. doi: 10.1111/j.1365-2591.2011.01950.x. Epub 2011 Sep 8.
PubMed 21902704Hashem 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 36574828Cooper SA, Desjardins P, Brain P, Paredes-Diaz A, Troullos E, Centofanti R, An B. Longer analgesic effect with naproxen sodium than ibuprofen in post-surgical dental pain: a randomized, double-blind, placebo-controlled, single-dose trial. Curr Med Res Opin. 2019 Dec;35(12):2149-2158. doi: 10.1080/03007995.2019.1655257. Epub 2019 Aug 27.
PubMed 31402718Tampi MP, Pilcher L, Urquhart O, Kennedy E, O'Brien KK, Lockhart PB, Abt E, Aminoshariae A, Durkin MJ, Fouad AF, Gopal P, Hatten BW, Lang MS, Patton LL, Paumier T, Suda KJ, Cho H, Carrasco-Labra A. Antibiotics for the urgent management of symptomatic irreversible pulpitis, symptomatic apical periodontitis, and localized acute apical abscess: Systematic review and meta-analysis-a report of the American Dental Association. J Am Dent Assoc. 2019 Dec;150(12):e179-e216. doi: 10.1016/j.adaj.2019.09.011.
PubMed 31761029Al-Hadidi F, Bsisu I, AlRyalat SA, Al-Zu'bi B, Bsisu R, Hamdan M, Kanaan T, Yasin M, Samarah O. Association between mobile phone use and neck pain in university students: A cross-sectional study using numeric rating scale for evaluation of neck pain. PLoS One. 2019 May 20;14(5):e0217231. doi: 10.1371/journal.pone.0217231. eCollection 2019.
PubMed 31107910Mkontwana N, Novikova N. Oral analgesia for relieving post-caesarean pain. Cochrane Database Syst Rev. 2015 Mar 29;2015(3):CD010450. doi: 10.1002/14651858.CD010450.pub2.
PubMed 25821010
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Trypsin-Chymotrypsin and Naproxen Sodium for Post-endodontic Treatment Pain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06562816
- Acronym / sponsor ID
- 3376
- Conditions
- Effect of Drug
- Keywords
- Trypsin-Chymotrypsin, Naproxen Sodium, Symptomatic Irreversible Pulpitis, Acute Irreversible Pulpitis, Post-endodontic treatment pain, Root canal treatment, Proteolytic Enzyme
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the pain reduction efficacy of Trypsin-Chymotrypsin and Naproxen sodium after root canal treatment in patients with symptomatic irreversible pulpitis. A lot of patients suffer greatly from post endodontic treatment pain and have a fear of dental treatments due to the pain. Patients refuse to go to the dentists and neglect oral hygiene care. That's why it is very important to find an effective drug regimen to reduce this post treatment pain. The null hypothesis is that there will be no difference between the efficacy and mean pain scores of Trypsin-chymotrypsin and Naproxen Sodium for post-endodontic treatment pain. Conducted as a triple-blinded, parallel, randomized controlled trial, 100 patients will be randomly assigned to receive either Trypsin-Chymotrypsin or Naproxen sodium following standard root canal therapy. Pain levels will be assessed using a numerical rating scale at 1, 6, 12, and 24 hours post-treatment to evaluate the effectiveness of these two pain management modalities.
Detailed description
- Background Prevention or management of pain, especially after root canal treatment, is of utmost importance to Endodontists. Non-steroidal anti-inflammatory drugs (NSAIDs) have been the most commonly used pain reduction modality in cases of irreversible pulpitis, but they do come with certain demerits. A lot of other alternatives have been researched as better alternatives for NSAIDs. Trypsin- Chymotrypsin has been proven to be an effective pain reducer after endodontic therapy. ii. Objective The objective of this study is to compare the pain reduction efficacy of Trypsin- Chymotrypsin and Naproxen sodium after root canal treatment. iii. Methodology In this triple-blinded, parallel, randomized controlled trial, a total of 100 patients will be included who are coming to the Operative Dentistry department for root canal treatment for any tooth. The patient must have a history of symptomatic irreversible pulpitis. The patients will be randomly allocated into two groups. One group (n = 50 will be the Trypsin- Chymotrypsin group, and the second group (n = 50) will be the Naproxen sodium group (active control group). The root canal treatment will be performed as usual. The first group will receive Trypsin- Chymotrypsin 1:100000 and the second group will receive Naproxen Sodium 550mg in sealed envelopes. The intensity of post-operative pain will be evaluated using a numerical rating scale at 1 hour, 6 hours, 12 hours, and 24 hour intervals. iv. Sequence Generation: Computer generated randomization using appropriate software (random.org) to assign the participants to trypsin-chymotrypsin or naproxen sodium group, ensuring a complete random allocation to each treatment arm, decreasing a risk of bias and enhancing the internal validity of the study.
- Blinding: The participants, researcher and outcome assessors will be blinded in this research (triple blinded). vi. Allocation Concealment: The allocation concealment will be achieved by packaging medicines in tightly sealed, opaque envelopes by a different person not conducting research or assessing outcomes. This process ensured that researchers involved in participant enrollment could not predict or influence the treatment assignment, reducing the risk of selection bias.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trypsin-Chymotrypsin | Experimental | Drug: Trypsin-ChymotrypsinThis group will receive sealed envelopes containing oral formulations of Trypsin:Chymotryspin in the ratio of 6:1 with an enzymatic activity of 100000 A.U./tablet (Tab. Chymoral Forte) three times a day, 30 minutes before meals for 24 hours. |
| Naproxen Sodium | Active comparator | Drug: Naproxen Sodium 550mgThe active control group will receive oral formulation of Naproxen Sodium 550mg (Tab. Synflex) twice a day, after meals for 24 hours. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both male and female, healthy patients (ASA class 1).
- Patients between the age group of 18-45 years.
- Patients who are appointed for endodontic treatment.
- Maxillary or mandibular teeth diagnosed with symptomatic irreversible pulpitis based on delayed responses to vitality tests.
Key exclusion criteria (6 listed)
- Patients who will require emergency dental treatment.
- Teeth with any form of peri-apical lesion will be excluded.
- Patient who have taken analgesics within 24 hours prior to the treatment.
- Patients with known hypersensitivity or allergy to any of the study medications.
- Patients with any systemic disease such as uncontrolled diabetes, gastric ulcers, bleeding disorders, or cardiovascular problems.
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 |
|---|---|---|
| Trypsin-ChymotrypsinAlso: Chymoral Forte100000 IU | Drug | Trypsin-Chymotrypsin |
| Naproxen Sodium 550mgAlso: Synflex 550mg550mg | Drug | Naproxen Sodium |
Primary outcome
Change in post-endodontic treatment pain score using Numeric Rating Scale
Time frame: 24 hours
The Numeric Rating Scale (NRS-11) is an eleven-point scale that ranges from 0, indicating no pain, to 10, representing the most severe pain the patient has ever encountered.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Background: PubMed 21902704Mehrvarzfar P, Abbott PV, Saghiri MA, Delvarani A, Asgar K, Lotfi M, Karamifar K, Kharazifard MJ, Khabazi H. Effects of three oral analgesics on postoperative pain following root canal preparation: a controlled clinical trial. Int Endod J. 2012 Jan;45(1):76-82. doi: 10.1111/j.1365-2591.2011.01950.x. Epub 2011 Sep 8.
- Background: 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.
- Background: PubMed 31402718Cooper SA, Desjardins P, Brain P, Paredes-Diaz A, Troullos E, Centofanti R, An B. Longer analgesic effect with naproxen sodium than ibuprofen in post-surgical dental pain: a randomized, double-blind, placebo-controlled, single-dose trial. Curr Med Res Opin. 2019 Dec;35(12):2149-2158. doi: 10.1080/03007995.2019.1655257. Epub 2019 Aug 27.
- Background: PubMed 31761029Tampi MP, Pilcher L, Urquhart O, Kennedy E, O'Brien KK, Lockhart PB, Abt E, Aminoshariae A, Durkin MJ, Fouad AF, Gopal P, Hatten BW, Lang MS, Patton LL, Paumier T, Suda KJ, Cho H, Carrasco-Labra A. Antibiotics for the urgent management of symptomatic irreversible pulpitis, symptomatic apical periodontitis, and localized acute apical abscess: Systematic review and meta-analysis-a report of the American Dental Association. J Am Dent Assoc. 2019 Dec;150(12):e179-e216. doi: 10.1016/j.adaj.2019.09.011.
- Background: PubMed 31107910Al-Hadidi F, Bsisu I, AlRyalat SA, Al-Zu'bi B, Bsisu R, Hamdan M, Kanaan T, Yasin M, Samarah O. Association between mobile phone use and neck pain in university students: A cross-sectional study using numeric rating scale for evaluation of neck pain. PLoS One. 2019 May 20;14(5):e0217231. doi: 10.1371/journal.pone.0217231. eCollection 2019.
- Background: PubMed 25821010Mkontwana N, Novikova N. Oral analgesia for relieving post-caesarean pain. Cochrane Database Syst Rev. 2015 Mar 29;2015(3):CD010450. doi: 10.1002/14651858.CD010450.pub2.
- Individual participant dataSharing planned: No. There is some information that can be sensitive to some patients. Sharing this data can compromise their confidentiality and cause a breach of their privacy. Anonymous data can be shared upon request.
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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.
Dr. Hafsa Zaki principal investigator
DUHS
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 Trypsin-Chymotrypsin and Naproxen Sodium 550mg in people with Effect of Drug, run by Dow University of Health Sciences at 1 site in Pakistan.
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 6 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: status not confirmed, as of the sponsor's last update on 4 Nov 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 Pakistan. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Hafsa Zaki, BDS (+923462746052, hafsazaki99@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in post-endodontic treatment pain score using Numeric Rating Scale (time frame: 24 hours). 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 NCT06562816, which also lists 6 linked publications.
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 4 Nov 2024.