Pulpitis - IrreversiblePhase 4NCT07088042
Assessment of Different Medications in Modifying the Efficacy of Anesthesia in Mandibular Molars With Acute Irreversible Pulpitis
A Phase 4 study testing Limitless Allzyme, Oral tablets of Alphintern® and Cataflam® 50 coated tablet in people with Pulpitis - Irreversible, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to assess the effect of preoperative Oral Tablets of Trypsin/Chymotrypsin/Bromelain Limitless Allzyme® (15 microkatal/42microkatal/240 GDU) Oral tablets of Alphintern® (Trypsin/Chymotrypsin 5 micro Katals/14 micro Katals) Oral Tablets Non-Steroidal Anti-inflammatory drug (Cataflam®… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- Limitless Allzyme, Oral tablets of Alphintern® and Cataflam® 50 coated tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2024to 17 Feb 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • From 18 to 65 years old.
- Both male and female participants were accepted.
- Mandibular molars diagnosed with acute irreversible pulpitis.
- Class I occlusion with normal occlusal contacts
Who cannot join
- • Individuals with significant health issues: a history of gastrointestinal disorders, active bronchial asthma, renal diseases, liver dysfunction, heart diseases, blood disorders, hypertension or poorly controlled diabetes mellitus.
- Immunocompromised patients.
- Sensitivity or allergy to any of the pharmaceuticals or medications intended for use in the study
- Participants who could not read, comprehend, or complete the baseline pain scale questionnaire.
- Cases where clinical examination suggested necrotic teeth leading to a false positive diagnosis.
- Teeth exhibiting periodontal disease or periapical lesions confirmed through clinical assessment and pre-operative radiographs.
- Sensitivity to percussion or palpation in the included teeth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Assessment of Different Medications in Modifying the Efficacy of Anesthesia in Mandibular Molars With Acute Irreversible Pulpitis (A Randomized Clinical Trial)"
The goal of this clinical trial is to assess the effect of preoperative
- Oral Tablets of Trypsin/Chymotrypsin/Bromelain Limitless Allzyme® (15 microkatal/42microkatal/240 GDU)
- Oral tablets of Alphintern® (Trypsin/Chymotrypsin 5 micro Katals/14 micro Katals)
- Oral Tablets Non-Steroidal Anti-inflammatory drug (Cataflam® 50mg)
Read more
Regarding the efficacy of the inferior alveolar nerve block anesthesia in mandibular molars with symptomatic irreversible pulpitis and post operative pain follow up for 3 days.
The main question it aims to answer are: • Does premedication increase the success rate of inferior alveolar nerve block.
Participants will describe their preoperative pain level to the investigator and describe their pain level during the treatment. Researchers will compare different premedication to see if it increases the success rate of inferior alveolar nerve block using Visual Analogue Scale (VAS), Electric Pulp testing and cavity test.
- Conditions
- Pulpitis - Irreversible
- Being tested
- Limitless Allzyme, Oral tablets of Alphintern®, Cataflam® 50 coated tablet
- Keywords
- premedication, bromelain trypsin chymotrypsin, efficacy of anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limitless AllzymeDrug
Received Limitless Allzyme Max® Trypsin/Chymotrypsin/Bromelain(15 microkatal/42microkatal/240 GDU)
Oral tablets of Alphintern®Drug
received (Trypsin/Chymotrypsin 5 micro Katals/14 micro Katals)
Cataflam® 50 coated tabletDrug
of Cataflam 50 mg as part of their treatment protocol
| Study group | Role | What they receive |
|---|---|---|
| Non-Steroidal Anti-inflammatory drug (Cataflam 50mg) | Active comparator | Received Cataflam Receives: Drug: Cataflam® 50 coated tablet |
| Inferior alveolar nerve block only | No intervention | received Inferior alveolar nerve block only |
| Oral Tablets of Limitless Allzyme | Experimental | Not described Receives: Drug: Limitless Allzyme |
| Alphintern® (Trypsin/Chymotrypsin 5 micro Katals/14 micro Katals) | Active comparator | Not described Receives: Drug: Oral tablets of Alphintern® |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the effect of Preoperative administration of- Oral tablets of Trypsin/Chymotrypsin/Bromelain) - Regarding the efficacy of the inferior alveolar nerve block anesthesia in mandibular molars with symptomatic irreversible pulpitis
Assessment of outcome is done using cavity test.
Measured: Up to 30 minutes from lip numbness until the end of pulp exacerbation and post operative pain follow up for 3 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start15 Sep 2024
- Primary completion17 Feb 2025
- Study completion17 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulpitis - IrreversibleStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088042
- Sponsor's protocol ID
- FDASU-RecIM012370
- Status last verified
- Feb 2025
- First submitted
- 6 May 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Assessment of Different Medications in Modifying the Efficacy of Anesthesia in Mandibular Molars With Acute Irreversible Pulpitis (A Randomized Clinical Trial)"
- ClinicalTrials.gov ID
- NCT07088042
- Acronym / sponsor ID
- FDASU-RecIM012370
- Conditions
- Pulpitis - Irreversible
- Keywords
- premedication, bromelain trypsin chymotrypsin, efficacy of anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 28 Jul 2025 (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.
The goal of this clinical trial is to assess the effect of preoperative
- Oral Tablets of Trypsin/Chymotrypsin/Bromelain Limitless Allzyme® (15 microkatal/42microkatal/240 GDU)
- Oral tablets of Alphintern® (Trypsin/Chymotrypsin 5 micro Katals/14 micro Katals)
- Oral Tablets Non-Steroidal Anti-inflammatory drug (Cataflam® 50mg)
Regarding the efficacy of the inferior alveolar nerve block anesthesia in mandibular molars with symptomatic irreversible pulpitis and post operative pain follow up for 3 days.
The main question it aims to answer are: • Does premedication increase the success rate of inferior alveolar nerve block.
Participants will describe their preoperative pain level to the investigator and describe their pain level during the treatment. Researchers will compare different premedication to see if it increases the success rate of inferior alveolar nerve block using Visual Analogue Scale (VAS), Electric Pulp testing and cavity test.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-Steroidal Anti-inflammatory drug (Cataflam 50mg) | Active comparator | Drug: Cataflam® 50 coated tabletReceived Cataflam |
| Inferior alveolar nerve block only | No intervention | –received Inferior alveolar nerve block only |
| Oral Tablets of Limitless Allzyme | Experimental | Drug: Limitless Allzyme |
| Alphintern® (Trypsin/Chymotrypsin 5 micro Katals/14 micro Katals) | Active comparator | Drug: Oral tablets of Alphintern® |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • From 18 to 65 years old.
Key exclusion criteria (7 listed)
- • Individuals with significant health issues: a history of gastrointestinal disorders, active bronchial asthma, renal diseases, liver dysfunction, heart diseases, blood disorders, hypertension or poorly controlled diabetes mellitus.
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 |
|---|---|---|
| Limitless AllzymeReceived Limitless Allzyme Max® Trypsin/Chymotrypsin/Bromelain(15 microkatal/42microkatal/240 GDU) | Drug | Oral Tablets of Limitless Allzyme |
| Oral tablets of Alphintern®received (Trypsin/Chymotrypsin 5 micro Katals/14 micro Katals) | Drug | Alphintern® (Trypsin/Chymotrypsin 5 micro Katals/14 micro Katals) |
| Cataflam® 50 coated tabletof Cataflam 50 mg as part of their treatment protocol | Drug | Non-Steroidal Anti-inflammatory drug (Cataflam 50mg) |
Primary outcome
assess the effect of Preoperative administration of- Oral tablets of Trypsin/Chymotrypsin/Bromelain) - Regarding the efficacy of the inferior alveolar nerve block anesthesia in mandibular molars with symptomatic irreversible pulpitis
Time frame: Up to 30 minutes from lip numbness until the end of pulp exacerbation and post operative pain follow up for 3 days.
Assessment of outcome is done using cavity test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Results publication: 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Limitless Allzyme, Oral tablets of Alphintern® and Cataflam® 50 coated tablet in people with Pulpitis - Irreversible, 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 7 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 28 Jul 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
assess the effect of Preoperative administration of- Oral tablets of Trypsin/Chymotrypsin/Bromelain) - Regarding the efficacy of the inferior alveolar nerve block anesthesia in mandibular molars with symptomatic irreversible pulpitis (time frame: Up to 30 minutes from lip numbness until the end of pulp exacerbation and post operative pain follow up for 3 days.). 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 NCT07088042, 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 28 Jul 2025.